BIOSIMILARS / THERAPEUTIC DRUG MONITORING

The Rituximab (Rituxan) ELISA kit is intended for the quantitative determination of Rituximab (Rituxan) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Rituximab is a monoclonal antibody which has high specificity for CD20 and it is used to treat certain
autoimmune diseases and types of cancer. It is also used for non-Hodgkin's lymphoma, chronic lymphocytic
leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis, idiopathic thrombocytopenic purpura,
pemphigus vulgaris, myasthenia gravis and Epstein - Barr virus-positive mucocutaneous ulcers. It is given by
slow injection into a vein.

Intended Use:
The KRIBIOLISA™ Rituximab ELISA is used as an analytical tool for quantitative determination of Rituximab in
serum and plasma.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Rituximab are
pre-coated onto microwells. Samples and standards are pipetted into microwells and human Rituximab
present in the sample are bound by the capture antibody. Then a HRP (horseradish peroxidase)
conjugated anti-Rituximab antibody is pipetted and incubated. After washing microwells in order to remove
any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Rituximab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm. 

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/KBI1010_KRIBIOLISA_Rituximab_ELISA_Insert_RUO_Ver_4_0.pdf

The Infliximab (Remicade) ELISA kit is intended for the quantitative determination of Infliximab (Remicade) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Infliximab is a monoclonal antibody which has high specificity for TNFα, and does not neutralize TNF beta.
Infliximab causes programmed cell death of TNFα-expressing activated T lymphocytes, an important cell type
mediating inflammation; hence it is generally assumed that resolution of activated T cells by Infliximab explains
its efficacy in Crohn's disease.

Intended Use:
The KRIBIOLISA™ Infliximab (Remicade™) ELISA is used as an analytical tool for quantitative determination
of Infliximab in serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Infliximab are
pre-coated onto microwells. Samples and standards are pipetted into microwells and human Infliximab
present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase)
conjugated anti-Infliximab antibody is pipetted and incubated. After washing microwells in order to remove
any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Infliximab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/KBI1011-KRIBIOLISA-Infliximab-Remicade-ELISA-Kit-Insert-3-1.pdf

KRIBIOLISA™ Infliximab (REMICADE) ELISA (measures total drug - free, bound or partially bound)

Quantitative immunoassay for Infliximab

The Infliximab (Remicade) ELISA kit is intended for the quantitative determination of total Infliximab (free, bound, or partially bound) in serum and plasma samples.

Pharmacokinetics (PK) is a branch of science dedicated to the quantitative analysis of absorption, distribution, metabolism and excretion of drug molecules within the body of a living organism.

All pre-clinical and clinical studies include the measurement of serum drug concentration, both in animals and in patients, at different points after drug administration. The result is an important indicator of the drug’s pharmacokinetic properties and is pertinently relevant to dosing recommendations while developing the drug, and even while using in clinical therapy.

Krishgen PK kits are used for the quantitation of serum protein drug levels to provide accurate pharmacokinetic (PK) data that will help optimize drug dosing regimens.

About the kit:
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are 80 - 120%
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.

https://krishgen.com/product/details/Infliximab-ELISA-measures-total-drug-free-bound-or-partially-bound-REMICADE

The Alemtuzumab (Lemtrada) ELISA kit is intended for the quantitative determination of Alemtuzumab (Lemtrada) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Alemtuzumab is a drug used in the treatment of chronic lymphocytic leukemia (CLL), cutaneous T-cell
lymphoma (CTCL) and T-cell lymphoma under the trade names Campath, MabCampath and Campath-1H,
and in the treatment of multiple sclerosis as Lemtrada. It is also used in some conditioning regimens for bone
marrow transplantation, kidney transplantation and islet cell transplantation. It is a monoclonal antibody that
binds to CD52, a protein present on the surface of mature lymphocytes, but not on the stem cells from which
these lymphocytes are derived. After treatment with alemtuzumab, these CD52-bearing lymphocytes are
targeted for destruction. MabCampath was withdrawn from the markets in the US and Europe in 2012 to
prepare for a higher-priced relaunch of Lemtrada aimed at multiple sclerosis.

Intended Use:
The KRIBIOLISA™ Alemtuzumab ELISA is used as an analytical tool for quantitative determination of
Alemtuzumab in human serum and plasma.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Alemtuzumab
are pre-coated onto microwells. Samples and standards are pipetted into microwells and human
Alemtuzumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish
peroxidase) conjugated anti-Alemtuzumab antibody is pipetted and incubated. After washing microwells in
order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells
and color develops proportionally to the amount of Alemtuzumab in the sample. Color development is then
stopped by addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://www.krishgen.com/upload/datasheets/KBI1012-KRIBIOLISA-Alemtuzumab-ELISA-ver4_0.pdf

The Etanercept (Enbrel) ELISA kit is intended for the quantitative determination of Etanercept (Enbrel) in serum, plasma and cell culture samples. CE IVD marked

2.5 ng/ml - 160 ng/ml

Introduction:
Etanercept is a biopharmaceutical that treats autoimmune diseases by interfering with tumor necrosis factor
(TNF, a soluble inflammatory cytokine) by acting as a TNF inhibitor. It has U.S. F.D.A. approval to treat
rheumatoid arthritis, juvenile rheumatoid arthritis and psoriatic arthritis, plaque psoriasis and ankylosing
spondylitis. TNF-alpha is the "master regulator" of the inflammatory (immune) response in many organ
systems. Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential
to treat these diseases by inhibiting TNF-alpha.

Intended Use:
The KRIBIOLISA™ Etanercept ELISA is used as an analytical tool for quantitative determination of Etanercept
in serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Etanercept are
pre-coated onto microwells. Samples and standards are pipetted into microwells and human Etanercept
present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase)
conjugated anti-Etanercept antibody is pipetted and incubated. After washing microwells in order to remove
any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Etanercept in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/KBI1013-Etanercept-IFU-ver1.0-CE-mlang.pdf

KRIBIOLISA™ Etarnacept (ENBREL) ELISA (measures total drug - free, bound or partially bound)

Quantitative immunoassay for Adalimumab

Immunoassay for the quantitative determination of Ustekinumab in serum, plasma and cell culture supernatant.

Ustekinumab is a human monoclonal antibody. It is directed against interleukin 12 and interleukin 23, naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. In two Phase III trials for moderate to severe psoriasis, the longest >76 weeks, ustekinumab was safe and effective. A third Phase III trial, ACCEPT, compared the efficacy and safety of ustekinumab with etanercept in the treatment of moderate to severe plaque psoriasis. This trial found a significantly higher clinical response with ustekinumab over the 12-week study period compared to high-dose etanercept. It also demonstrated the clinical benefit of ustekinumab among patients who failed to respond to etanercept. Ustekinumab is approved in Canada, Europe
and the United States to treat moderate to severe plaque psoriasis.

Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well.

About the kit:
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are between 85 - 115%
- Ready to use with a standard protocol with break-apart pre-coated wells
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.
- Shelf life: 1 year

The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Ustekinumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Ustekinumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Ustekinumab antibody is pipetted and incubated. After washing microwells in order to remove any nonspecific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Ustekinumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

The Ustekinumab (Stelara) ELISA kit is intended for the quantitative determination of Ustekinumab (Stelara) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Ustekinumab is a human monoclonal antibody. It is directed against interleukin 12 and interleukin 23, naturally
occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. In two Phase
III trials for moderate to severe psoriasis, the longest >76 weeks, ustekinumab was safe and effective. A third
Phase III trial, ACCEPT, compared the efficacy and safety of ustekinumab with etanercept in the treatment of
moderate to severe plaque psoriasis. This trial found a significantly higher clinical response with ustekinumab
over the 12-week study period compared to high-dose etanercept. It also demonstrated the clinical benefit of
ustekinumab among patients who failed to respond to etanercept. Ustekinumab is approved in Canada, Europe
and the United States to treat moderate to severe plaque psoriasis.

Intended Use:
The KRIBIOLISA™ Ustekinumab ELISA is a rapid and easy method for the quantitative determination of
Ustekinumab in human serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Ustekinumab are
pre-coated onto microwells. Samples and standards are pipetted into microwells and human Ustekinumab
present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated
anti-Ustekinumab antibody is pipetted and incubated. After washing microwells in order to remove any nonspecific binding, the ready to use substrate solution (TMB) is added to microwells and color develops
proportionally to the amount of Ustekinumab in the sample. Color development is then stopped by addition of stop
solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/KBI1014-KRIBIOLISA-USTEKINUMAB-STELARA-ELISA-VER-4-0-RUO.pdf

The Adalimumab (Humira) ELISA kit is intended for the quantitative determination of Adalimumab (Humira) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor
alpha (TNF-α). Adalimumab is produced by recombinant DNA technology in a mammalian cell expression
system and is purified by a process that includes specific viral inactivation and removal steps. Adalimumab
binds specifically to (TNF-α) and blocks its interaction with the p55 and p75 cell surface TNF receptors. TNF is
a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels
of TNF are found in the synovial fluid of rheumatoid arthritis, including juvenile idiopathic arthritis, psoriatic
arthritis, and ankylosing spondylitis patients and play an important role in both the pathologic inflammation and
the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in psoriasis
(Ps) plaques.

Intended Use:
The KRIBIOLISA™ Adalimumab (Humira™) ELISA is used as an analytical tool for quantitative determination of
Adalimumab in serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Adalimumab are
pre-coated onto microwells. Samples and standards are pipetted into microwells and human Adalimumab
present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase)
conjugated anti-Adalimumab antibody is pipetted and incubated. After washing microwells in order to remove
any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Adalimumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/Kribiolisa_Adalimumab_Humira_KBI1015-IFU_ver3-1_RUO.pdf

KRIBIOLISA™ Adalimumab ELISA - Antigen Capture (measures specifically the bound drug complex)

Quantitative immunoassay for Cetuximab

The antigen capture Adalimumab (Humira) ELISA kit is intended for the quantitative determination of bound drug complex of Adalimumab in serum, plasma and cell culture samples.

Pharmacokinetics (PK) is a branch of science dedicated to the quantitative analysis of absorption, distribution, metabolism and excretion of drug molecules within the body of a living organism.

All pre-clinical and clinical studies include the measurement of serum drug concentration, both in animals and in patients, at different points after drug administration. The result is an important indicator of the drug’s pharmacokinetic properties and is pertinently relevant to dosing recommendations while developing the drug, and even while using in clinical therapy.

Krishgen PK kits are used for the quantitation of serum protein drug levels to provide accurate pharmacokinetic (PK) data that will help optimize drug dosing regimens.

About the kit:
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are 80 - 120%
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.

https://krishgen.com/product/details/Adalimumab-ELISA-Antigen-Capture-measures-specifically-the-bound-drug-complex

The Bevacizumab (Avastin) ELISA kit is intended for the quantitative determination of Bevacizumab (Avastin) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Bevacizumab is a recombinant Human IgG;κ monoclonal antibody specific for all human vascular endothelial
growth factor A (VEGF-A) isoforms. Additionally, Bevacizumab binds to and neutralizes all human VEGF-A
isoforms an bioactive proteolytic fragments, but not mouse or rat VEGF.

Intended Use:
The KRIBIOLISA™ Bevacizumab (Avastin™) ELISA is used as an analytical tool for quantitative
determination of Bevacizumab in human serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Bevacizumab
are pre-coated onto microwells. Samples and standards are pipetted into microwells and human
Bevacizumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish
peroxidase) conjugated anti-Bevacizumab antibody is pipetted and incubated. After washing microwells in
order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to
microwells and color develops proportionally to the amount of Bevacizumab in the sample. Color
development is then stopped by addition of stop solution. Absorbance is measured at 450 nm. 

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/KBI1016-Bevacizumab-IFU-ver4.1-CE-mlang.pdf

The Trastuzumab (Herceptin) ELISA kit is intended for the quantitative determination of Trastuzumab (Herceptin) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Trastuzumab is a humanized monoclonal antibody which targets Her-2/neu receptor. Trastuzumab is
approved for use in treating breast cancers and is being tested for other cancers that over expresses HER2/neu.

Intended Use:
The KRIBIOLISA™ Trastuzumab (HERCEPTINTM) ELISA is used as an analytical tool for quantitative
determination of Trastuzumab in serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Trastuzumab are
pre-coated onto microwells. Samples and standards are pipetted into microwells and human Trastuzumab
present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase)
conjugated anti-Trastuzumab antibody is pipetted and incubated. After washing microwells in order to remove
any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Trastuzumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/KBI1017_Kribiolisa_Trastuzumab-(HERCEPTIN)_ELISA_RUO_Ver5-0.pdf

KRIBIOLISA™ Trastuzumab (HERCEPTIN) ELISA (measures specifically the bound drug complex)

Quantitative immunoassay for Omalizumab

The antigen capture Trastuzumab (HERCEPTIN) ELISA kit is intended for the quantitative determination of bound drug complex of Trastuzumab in serum, plasma and cell culture samples.

Pharmacokinetics (PK) is a branch of science dedicated to the quantitative analysis of absorption, distribution, metabolism and excretion of drug molecules within the body of a living organism.

All pre-clinical and clinical studies include the measurement of serum drug concentration, both in animals and in patients, at different points after drug administration. The result is an important indicator of the drug’s pharmacokinetic properties and is pertinently relevant to dosing recommendations while developing the drug, and even while using in clinical therapy.

Krishgen PK kits are used for the quantitation of serum protein drug levels to provide accurate pharmacokinetic (PK) data that will help optimize drug dosing regimens.

About the kit:
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are 80 - 120%
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.

https://krishgen.com/product/details/Trastuzumab-ELISA-measures-specifically-the-bound-drug-complex-HERCEPTIN

The Cetuximab (Erbitux) ELISA kit is intended for the quantitative determination of Cetuximab (Erbitux) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor used for the treatment of
metastatic colorectal cancer, metastatic non-small cell lung cancer and head and neck cancer. Cetuximab
is a chimeric (mouse/human) monoclonal antibody given by intravenous infusion that is distributed under
the trade name Erbitux in the U.S. and Canada by the drug company Bristol-Myers Squibb and outside
the U.S. and Canada by the drug company Merck KGaA. In Japan, Merck KGaA, Bristol-Myers Squibb
and Eli Lilly have a co-distribution. In July 2009, FDA approved Cetuximab (Erbitux) for treatment of
colon cancer with wild-type KRAS, since it had little or no effect in colorectal tumors harboring
a KRAS mutation (this also applied to the EGFR antibody panitumumab).

Intended Use:
The KRIBIOLISA™ Cetuximab ELISA is used as an analytical tool for quantitative determination of
Cetuximab in human serum and plasma.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Cetuximab
are pre-coated onto microwells. Samples and standards are pipetted into microwells and human
Cetuximab present in the sample are bound by the capture antibody. Then a HRP (horseradish
peroxidase) conjugated anti-Cetuximab antibody is pipetted and incubated. After washing microwells in
order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to
microwells and color develops proportionally to the amount of Cetuximab in the sample. Color
development is then stopped by addition of stop solution. Absorbance is measured at 450 nm. 

Human, Mouse and Rat Available for Customisation

https://krishgen.com/product/details/Cetuximab-ELISA-measures-free-and-partially-bound-drug-ERBITUX

https://krishgen.com/upload/datasheets/KBI1018_Cetuximab_(ERBITUX)_ELISA_Kit_Insert_Ver4-0_.pdf

Quantitative immunoassay for Eculizumab

This Cetuximab (Erbitux) ELISA kit is intended for the quantitative determination of free and partially bound Cetuximab in serum, plasma and cell culture samples.

Pharmacokinetics (PK) is a branch of science dedicated to the quantitative analysis of absorption, distribution, metabolism and excretion of drug molecules within the body of a living organism.

All pre-clinical and clinical studies include the measurement of serum drug concentration, both in animals and in patients, at different points after drug administration. The result is an important indicator of the drug’s pharmacokinetic properties and is pertinently relevant to dosing recommendations while developing the drug, and even while using in clinical therapy.

Krishgen PK kits are used for the quantitation of serum protein drug levels to provide accurate pharmacokinetic (PK) data that will help optimize drug dosing regimens.

About the kit:
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are 80 - 120%
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.

https://krishgen.com/product/details/Cetuximab-ELISA-measures-free-and-partially-bound-drug-ERBITUX

The Golimumab (Simponi) ELISA kit is intended for the quantitative determination of Golimumab (Simponi) in serum, plasma and cell culture samples

Introduction:
Golimumab (CNTO 148) is a human monoclonal antibody which is used as an immunosuppressive drug and
marketed under the brand name Simponi. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a proinflammatory molecule and hence is a TNF inhibitor. Profound reduction in C-reactive protein (CRP) levels,
interleukin (IL)-6, intercellaular adhesion molecules (ICAM)-1, matrix metalloproteinase (MMP)-3, and vascular
endothelial growth factor (VEGF) demonstrates golimumab as an effective modulator of inflammatory markers
and bone metabolism.

Intended Use:
The KRIBIOLISA™ Golimumab ELISA is used as an analytical tool for quantitative determination of Golimumab
in serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Golimumab are
pre-coated onto microwells. Samples and standards are pipetted into microwells and human Golimumab
present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase)
conjugated anti-Golimumab antibody is pipetted and incubated. After washing microwells in order to remove
any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Golimumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/product/details/Golimumab-ELISA-measures-total-drug-free-bound-or-partially-bound-SIMPONI

https://krishgen.com/upload/datasheets/KBI1019-Golimumab-IFU-ver1.0-CE-mlang.pdf

KRIBIOLISA™ Golimumab (SIMPONI) ELISA (measures total drug - free, bound or partially bound)

Quantitative immunoassay for Denosumab

The Golimumab (SIMPONI) ELISA kit is intended for the quantitative determination of total Golimumab (free, bound, or partially bound) in serum and plasma samples.

Pharmacokinetics (PK) is a branch of science dedicated to the quantitative analysis of absorption, distribution, metabolism and excretion of drug molecules within the body of a living organism.

All pre-clinical and clinical studies include the measurement of serum drug concentration, both in animals and in patients, at different points after drug administration. The result is an important indicator of the drug’s pharmacokinetic properties and is pertinently relevant to dosing recommendations while developing the drug, and even while using in clinical therapy.

Krishgen PK kits are used for the quantitation of serum protein drug levels to provide accurate pharmacokinetic (PK) data that will help optimize drug dosing regimens.

About the kit:
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are 80 - 120%
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.

https://krishgen.com/product/details/Golimumab-ELISA-measures-total-drug-free-bound-or-partially-bound-SIMPONI

KRIBIOLISA™ Golimumab (SIMPONI) ELISA (measures specifically the bound drug complex)

Quantitative immunoassay for Atezolizumab

The antigen capture Golimumab (SIMPONI) ELISA kit is intended for the quantitative determination of bound drug complex of Golimumab in serum, plasma and cell culture samples.

Pharmacokinetics (PK) is a branch of science dedicated to the quantitative analysis of absorption, distribution, metabolism and excretion of drug molecules within the body of a living organism.

All pre-clinical and clinical studies include the measurement of serum drug concentration, both in animals and in patients, at different points after drug administration. The result is an important indicator of the drug’s pharmacokinetic properties and is pertinently relevant to dosing recommendations while developing the drug, and even while using in clinical therapy.

Krishgen PK kits are used for the quantitation of serum protein drug levels to provide accurate pharmacokinetic (PK) data that will help optimize drug dosing regimens.

About the kit:
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are 80 - 120%
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.

https://krishgen.com/product/details/Golimumab-ELISA-measures-specifically-the-bound-drug-complex-SIMPONI

The Natalizumab (Tysabri) ELISA kit is an assay intended for the quantitative determination of Natalizumab (Tysabri) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Natalizumab (Tysabri®) is a humanized monoclonal antibody against the cell adhesion molecule α4-integrin used in
the treatment of multiple sclerosis and Crohn’s disease. Tysabri® and was previously named Antegren®. Natalizumab
is administered by intravenous infusion every 28 days and reduces the ability of inflammatory immune cells to attach to
and pass through the cell layers lining the intestines and blood–brain barrier.

Intended Use:
The KRIBIOLISA™ Natalizumab ELISA is used as an analytical tool for quantitative determination of
Natalizumab in serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Natalizumab are
pre-coated onto microwells. Samples and standards are pipetted into microwells and human Natalizumab
present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase)
conjugated anti-Natalizumab antibody is pipetted and incubated. After washing microwells in order to remove
any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Natalizumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/KBI1020-Natalizumab-IFU-ver1.0-CE-mlang.pdf

The Omalizumab (Xolair) ELISA kit is intended for the quantitative determination of Omalizumab (Xolair) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Omalizumab, sold under the trade name Xolair, is a medication originally designed to reduce sensitivity to allergens. It
has been used to try to control severe allergic asthma, which does not respond to high doses of corticosteroids and
less widely for chronic spontaneous urticaria.Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal
antibody that specifically binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to
membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes. Unlike an ordinary anti-IgE
antibody, it does not bind to IgE that is already bound by the high affinity IgE receptor (FcεRI) on the surface of mast
cells, basophils, and antigen-presenting dendritic cells.

Intended Use:
The KRIBIOLISA™ Omalizumab ELISA is used as an analytical tool for quantitative determination of
Omalizumab in serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Omalizumab are
pre-coated onto microwells. Samples and standards are pipetted into microwells and human Omalizumab
present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase)
conjugated anti-Omalizumab antibody is pipetted and incubated. After washing microwells in order to remove
any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Omalizumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/product/details/Omalizumab-IgE-ELISA-measures-specifically-the-bound-drug-complex-XOLAIR

https://krishgen.com/upload/datasheets/KBI1021-Omalizumab-IFU-ver1.0-CE-mlang.pdf

KRIBIOLISA™ Omalizumab (XOLAIR) IgE ELISA (measures specifically the bound drug complex)

Quantitative immunoassay for Anti-Rituximab

The antigen capture Omalizumab (XOLAIR) ELISA kit is intended for the quantitative determination of bound drug complex of Omalizumab in serum, plasma and cell culture samples.

Pharmacokinetics (PK) is a branch of science dedicated to the quantitative analysis of absorption, distribution, metabolism and excretion of drug molecules within the body of a living organism.

All pre-clinical and clinical studies include the measurement of serum drug concentration, both in animals and in patients, at different points after drug administration. The result is an important indicator of the drug’s pharmacokinetic properties and is pertinently relevant to dosing recommendations while developing the drug, and even while using in clinical therapy.

Krishgen PK kits are used for the quantitation of serum protein drug levels to provide accurate pharmacokinetic (PK) data that will help optimize drug dosing regimens.

About the kit:
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are 80 - 120%
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.

https://krishgen.com/product/details/Omalizumab-IgE-ELISA-measures-specifically-the-bound-drug-complex-XOLAIR

The Tocilizumab (Actemra) ELISA kit is intended for the quantitative determination of Tocilizumab (Actemra) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Tocilizumab, also known as atlizumab, is an immunosuppressive drug, mainly for the treatment of rheumatoid
arthritis (RA) and systemic juvenile idiopathic arthritis, a severe form of arthritis in children. It is a humanized
monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an
important role in immune response and is implicated in the pathogenesis of many diseases, such as
autoimmune diseases, multiple myeloma and prostate cancer. It was developed by Hoffmann–La Roche and
Chugai.

Intended Use:
The KRIBIOLISA™ Tocilizumab ELISA is used as an analytical tool for quantitative determination of
Tocilizumab in serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Tocilizumab are
pre-coated onto microwells. Samples and standards are pipetted into microwells and human Tocilizumab
present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase)
conjugated anti-Tocilizumab antibody is pipetted and incubated. After washing microwells in order to remove
any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Tocilizumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/product/details/KRIBIOLISA-Tocilizumab-ACTEMRA-ELISA-CE-MARKED

https://krishgen.com/upload/datasheets/KBI1022-Kribiolisa-Tocilizumab-ELISA-ver-2-0.pdf

KRIBIOLISA™ Tocilizumab (ACTEMRA) ELISA (measures total drug - free, bound or partially bound)

Quantitative immunoassay for Anti-Infliximab

The Tocilizumab (ACTEMRA) ELISA kit is intended for the quantitative determination of total Tocilizumab (free, bound, or partially bound) in serum and plasma samples.

Pharmacokinetics (PK) is a branch of science dedicated to the quantitative analysis of absorption, distribution, metabolism and excretion of drug molecules within the body of a living organism.

All pre-clinical and clinical studies include the measurement of serum drug concentration, both in animals and in patients, at different points after drug administration. The result is an important indicator of the drug’s pharmacokinetic properties and is pertinently relevant to dosing recommendations while developing the drug, and even while using in clinical therapy.

Krishgen PK kits are used for the quantitation of serum protein drug levels to provide accurate pharmacokinetic (PK) data that will help optimize drug dosing regimens.

About the kit:
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are 80 - 120%
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.

https://krishgen.com/product/details/Tocilizumab-ELISA-measures-total-drug-free-bound-or-partially-bound-ACTEMRA

The Eculizumab (Soliris) ELISA kit is intended for the quantitative determination of Eculizumab (Soliris) in serum, plasma and cell culture samples. CE IVD marked

The Eculizumab (Soliris) ELISA kit is intended for the quantitative determination of Eculizumab (Soliris) in serum, plasma and cell culture samples. CE IVD marked.

Pharmacokinetics (PK) is a branch of science dedicated to the quantitative analysis of absorption, distribution, metabolism and excretion of drug molecules within the body of a living organism.

All pre-clinical and clinical studies include the measurement of serum drug concentration, both in animals and in patients, at different points after drug administration. The result is an important indicator of the drug’s pharmacokinetic properties and is pertinently relevant to dosing recommendations while developing the drug, and even while using in clinical therapy.

Krishgen PK kits are used for the quantitation of serum protein drug levels to provide accurate pharmacokinetic (PK) data that will help optimize drug dosing regimens.

About the kit:
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are 80 - 120%
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/KBI1024_KRIBIOLISA_Eculizumab_IFU_Ver_4_0.pdf

The Ipilimumab (Yervoy) ELISA kit is an assay intended for the quantitative determination of Ipilimumab (Yervoy) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Ipilimumab, sold under the brand name Yervoy, is a monoclonal antibody medication that works to activate the
immune system by targeting CTLA-4, a protein receptor that downregulates the immune system. Cytotoxic T
lymphocytes can recognize and destroy cancer cells.

Intended Use:
The KRIBIOLISA™ Ipilimumab (YERVOY) ELISA is used as an analytical tool for the quantitative determination
of Ipilimumab in human serum and plasma.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Ipilimumab are
pre-coated onto microwells. Samples and standards are pipetted into microwells and human Ipilimumab
present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase)
conjugated anti-Human IgG antibody is pipetted and incubated. After washing microwells in order to remove
any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Ipilimumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/KBI1025-Kribiolisa-Ipilumumab-KBI1025-IFU-ver4.0-RUO.pdf

KRIBIOLISA™ Ipilimumab (YERVOY) ELISA (measures specifically the bound drug complex)

Quantitative immunoassay for Anti- Ustekinumab

The antigen capture Ipilimumab (YERVOY) ELISA kit is intended for the quantitative determination of bound drug complex of Ipilimumab in serum, plasma and cell culture samples.

Pharmacokinetics (PK) is a branch of science dedicated to the quantitative analysis of absorption, distribution, metabolism and excretion of drug molecules within the body of a living organism.

All pre-clinical and clinical studies include the measurement of serum drug concentration, both in animals and in patients, at different points after drug administration. The result is an important indicator of the drug’s pharmacokinetic properties and is pertinently relevant to dosing recommendations while developing the drug, and even while using in clinical therapy.

Krishgen PK kits are used for the quantitation of serum protein drug levels to provide accurate pharmacokinetic (PK) data that will help optimize drug dosing regimens.

About the kit:
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are 80 - 120%
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.

https://krishgen.com/product/details/Ipilimumab-ELISA-measures-specifically-the-bound-drug-complex-YERVOY

The Denosumab (Prolia) assay kit is an ELISA intended for the quantitative determination of Denosumab (Prolia) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Denosumab (trade names Prolia and Xgeva) is a human monoclonal antibody for the treatment of
osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone. Denosumab is
contraindicated in people with low blood calcium levels. The most common side effects are joint and muscle
pain in the arms or legs. Denosumab is a RANKL inhibitor, which works by preventing the development of
osteoclasts which are cells that break down bone (bone resorption).

Intended Use:
The KRIBIOLISA™ Denosumab (PROLIA) ELISA is used as an analytical tool for quantitative determination of
Denosumab (PROLIA) in serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Denosumab
are pre-coated onto microwells. Samples and standards are pipetted into microwells and human
Denosumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish
peroxidase) conjugated Anti-Denosumab antibody is pipetted and incubated. After washing microwells in
order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells
and color develops proportionally to the amount of Denosumab in the sample. Color development is then
stopped by addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/product/details/Denosumab-ELISA-measures-free-and-partially-bound-drug-PROLIA

https://krishgen.com/upload/datasheets/KBI1026-Denosumab-IFU-ver1.0-CE-mlang.pdf

Quantitative immunoassay for Denosumab

Introduction:
Denosumab (trade names Prolia™ and Xgeva™) is a human monoclonal antibody for the treatment of
osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone. Denosumab is
contraindicated in people with low blood calcium levels. The most common side effects are joint and muscle
pain in the arms or legs. Denosumab is a RANKL inhibitor, which works by preventing the development of
osteoclasts which are cells that break down bone (bone resorption).

Intended Use:
The KRIBIOLISA™ Denosumab (PROLIA) ELISA is used as an analytical tool for quantitative determination of
Denosumab (PROLIA) in human serum and plasma. Denosumab is a fully human monoclonal antibody that
binds the cytokine RANKL (receptor activator of NFκB ligand). The capture antibody in the KRIBIOLISA™
Denosumab ELISA kit inhibits the binding of Denosumab to RANKL leading to the kit estimating only the free
and partially bound Denosumab in samples.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Denosumab
free drug are pre-coated onto microwells. Samples and standards are pipetted into microwells and human
Denosumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish
peroxidase) conjugated anti-Denosumab antibody is pipetted and incubated. After washing microwells in
order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells
and color develops proportionally to the amount of Denosumab in the sample. Color development is then
stopped by addition of stop solution. Absorbance is measured at 450 nm.

https://krishgen.com/product/details/Denosumab-ELISA-measures-free-and-partially-bound-drug-PROLIA

https://www.krishgen.com/upload/datasheets/Denosumab_(PROLIA)_KBI1026-2_ver1-0_RUO.pdf

The Atezolizumab (Tecentriq) ELISA kit is an assay intended for the quantitative determination of Atezolizumab (Tecentriq) in serum, plasma and cell culture samples. CE IVD marked

Introduction:
Denosumab (trade names Prolia™ and Xgeva™) is a human monoclonal antibody for the treatment of
osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone. Denosumab is
contraindicated in people with low blood calcium levels. The most common side effects are joint and muscle
pain in the arms or legs. Denosumab is a RANKL inhibitor, which works by preventing the development of
osteoclasts which are cells that break down bone (bone resorption).

Intended Use:
The KRIBIOLISA™ Denosumab (PROLIA) ELISA is used as an analytical tool for quantitative determination of
Denosumab (PROLIA) in human serum and plasma. Denosumab is a fully human monoclonal antibody that
binds the cytokine RANKL (receptor activator of NFκB ligand). The capture antibody in the KRIBIOLISA™
Denosumab ELISA kit inhibits the binding of Denosumab to RANKL leading to the kit estimating only the free
and partially bound Denosumab in samples.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Denosumab
free drug are pre-coated onto microwells. Samples and standards are pipetted into microwells and human
Denosumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish
peroxidase) conjugated anti-Denosumab antibody is pipetted and incubated. After washing microwells in
order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells
and color develops proportionally to the amount of Denosumab in the sample. Color development is then
stopped by addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/KBI1027-Atezolizumab-Tecentriq-ELISA-ver2.1.pdf

The Daratumumab (Darzalex) ELISA kit is an assay intended for the quantitative determination of Daratumumab (Darzalex) in serum, plasma and cell culture samples. CE IVD marked

0 ng/ml - 2560 ng/ml

Introduction:
Daratumumab (trade name Darzalex) is an anti-cancer drug. It binds to CD38, which multiple myeloma cells
overexpress. Daratumumab was originally developed by Genmab, but it is now being jointly developed by
Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide
commercialization rights to the drug from Genmab.Daratumumab was given breakthrough therapy drug status in
2013 for multiple myeloma. It was awarded orphan drug status for multiple myeloma, diffuse large B cell
lymphoma, follicular lymphoma, and mantle cell lymphoma.

Intended Use:
The KRIBIOLISA™ Daratumumab (Darzalex™) ELISA is used as an analytical tool for quantitative determination
of Daratumumab in serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Daratumumab are
pre-coated onto microwells. HRP Conjugate, Samples / Standards are pipetted into microwells and human
Daratumumab present in the sample are bound by the capture antibody. After washing microwells in order to
remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Daratumumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/KBI1028-Daratumumab-IFU-ver1.0-CE-mlang.pdf

The Ranibizumab (Lucentis) kit is an assay intended for the quantitative determination of Ranibizumab (Lucentis) in serum, plasma and cell culture samples.



Key features:

<ul>
<li>uses highly specific monoclonal anti-idiotypic antibodies</li>
<li>calibrators used is commerically available daratumumab injection itself</li>
<li>Recovery: 80-120%</li>
<li>Precision CV <15%</li>
</ul>

Introduction:
Ranibizumab (Lucentis) is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and
inhibits vascular endothelial growth factor A (VEGF-A). VEGF is a biochemical signal protein that promotes
angiogenesis throughout the body and in the eye. Through binding to VEGF-A, ranibizumab interrupts the
interaction of VEGF with its receptors, and thus prevents the subsequent growth of new blood vessels.

Intended Use:
The KRIBIOLISA™ Ranibizumab (LucentisTM) ELISA is used as an analytical tool for quantitative determination
of Ranibizumab in serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Ranibizumab are
pre-coated onto microwells. HRP Conjugate, Samples / Standards are pipetted into microwells and human
Ranibizumab present in the sample are bound by the capture antibody. After washing microwells in order to
remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Ranibizumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/KBI1029-Kribiolisa-Ranibizumab-ELISA-RUO-ver4.0.pdf

KRIBIOLISA™ Ranibizumab (LUCENTIS) ELISA (measures total drug - free, bound or partially bound)

Quantitative immunoassay for Anti-Natalizumab

Introduction:
Ranibizumab (Lucentis) is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and
inhibits vascular endothelial growth factor A (VEGF-A). VEGF is a biochemical signal protein that promotes
angiogenesis throughout the body and in the eye. Through binding to VEGF-A, ranibizumab interrupts the
interaction of VEGF with its receptors, and thus prevents the subsequent growth of new blood vessels.
This kit KRIBIOLISA™ Ranibizumab (Lucentis™) ELISA specifically recognizes the monoclonal antibody drug
Ranibizumab and Ranibizumab when in complex with recombinant human vascular endothelial growth factor A
(VEGF-A). It does not recognize free human VEGF-A or bevacizumab. This kit can be used to measure levels of
free Ranibizumab and biosimilars in patient samples.

Intended Use:
The KRIBIOLISA™ Ranibizumab (Lucentis™) ELISA is used as an analytical tool for quantitative determination
of Ranibizumab in serum and plasma. The kit measures total drug (free, bound or partially bound).

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Ranibizumab are
pre-coated onto microwells. HRP Conjugate, Samples / Standards are pipetted into microwells and human
Ranibizumab present in the sample are bound by the capture antibody. After washing microwells in order to
remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Ranibizumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm. 

https://krishgen.com/product/details/Ranibizumab-ELISA-measures-total-drug-free-bound-or-partially-bound-LUCENTIS

https://krishgen.com/upload/datasheets/KBI1029-3_KRIBIOLISA_Ranibizumab-ELISA_RUO_ver1-0.pdf

KRIBIOLISA™ Ranibizumab (LUCENTIS) ELISA (measures specifically the bound drug complex)

Quantitative immunoassay for Anti-Omalizumab

Introduction:
Ranibizumab (Lucentis) is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and
inhibits vascular endothelial growth factor A (VEGF-A). VEGF is a biochemical signal protein that promotes
angiogenesis throughout the body and in the eye. Through binding to VEGF-A, ranibizumab interrupts the
interaction of VEGF with its receptors, and thus prevents the subsequent growth of new blood vessels.
This kit KRIBIOLISA™ Ranibizumab (Lucentis™) ELISA specifically recognizes Ranibizumab only when bound
to its target, human VEGF-A. It does not recognize free human VEGF-A or bevacizumab. The kit can be used to
measure levels of bound Ranibizumab and biosimilars in patient samples.

Intended Use:
The KRIBIOLISA™ Ranibizumab (Lucentis™) ELISA is used as an analytical tool for quantitative determination
of Ranibizumab in serum and plasma. The kit measures bound Ranibizumab complex.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Ranibizumab are
pre-coated onto microwells. HRP Conjugate, Samples / Standards are pipetted into microwells and human
Ranibizumab present in the sample are bound by the capture antibody. After washing microwells in order to
remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Ranibizumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm. 

https://krishgen.com/product/details/Ranibizumab-ELISA-measures-specifically-the-bound-drug-complex-LUCENTIS

https://krishgen.com/upload/datasheets/KBI1029-4_KRIBIOLISA_Ranibizumab-ELISA_RUO_ver1-0.pdf

The Darbepoetin (Aranesp) ELISA kit is an assay intended for the quantitative determination of Darbepoetin (Aranesp) in serum, plasma and cell culture samples. CE IVD marked

0.625 ng/ml - 20 ng/ml

Introduction:
Erythropoietin (EPO) is a heavily glycosylated protein with a molecular weight of about 30,000 - 34,000
Daltons. Human EPO is a polypeptide consisting of 165 amino acids, containing one O-linked and three Nlinked carbohydrate chains. The recombinant EPO is a good substitute for the native protein for use in an
immunoassay. Darbepoetin is a re-engineered form of erythropoietin, contains 5 N-linked oligosaccharide
chains and has a molecular weight of 37,100 Daltons and a carbohydrate composition of 51%.It has a 3-fold
longer serum half-life compared to epoetin alpha and epoetin beta.

Intended Use:
The KRIBIOLISA™ Darbepoetin (ARANESP) ELISA is used as an analytical tool for quantitative determination
of Darbepoetin in human serum and plasma.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique Standards or samples are
pipetted into microwells pre-coated with Anti-Darbepoetin antibody and Darbepoetin present in the sample and
standards are bound by Anti-Darbepoetin antibody. In the second step, Detection antidody is added and
incubated. In the third step, a HRP conjugate is pipetted and incubated. Free HRP conjugate will be removed by
washing. Addition of TMB substrate will develop blue color and intensity of blue colour in wells is proportional to
the concentration of Darbepoetin present in standard or sample. Color development is then stopped by addition
of stop solution. Absorbance is measured at 450 nm.

https://krishgen.com/upload/datasheets/Kribiolisa_Darbepoetin_KBI1030-IFU_ver_2_0_RUO.pdf

Quantitative immunoassay for Anti-Eculizumab

Enzyme Immunoassay for the quantitative determination of Daratumumab in serum, plasma and cell culture supernatant.


Daratumumab (trade name Darzalex) is an anti-cancer drug. It binds to CD38, which multiple myeloma cells overexpress. Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab.Daratumumab was given breakthrough therapy drug status in 2013 for multiple myeloma. It was awarded orphan drug status for multiple myeloma, diffuse large B cell
lymphoma, follicular lymphoma, and mantle cell lymphoma.


Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well.

About the kit:
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are between 85 - 115%
- Ready to use with a standard protocol with break-apart pre-coated wells
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.
- Shelf life: 1 year

The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Daratumumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Daratumumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Daratumumab antibody is pipetted and incubated. After washing microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells
and color develops proportionally to the amount of Daratumumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

The Nivolumab (Opdivo) ELISA kit is an assay intended for the quantitative determination of Nivolumab (Opdivo) in serum, plasma and cell culture samples. RUO only

Introduction:
OPDIVO® (Nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) as a first
treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your
lung cancer has spread to other parts of your body (metastatic) and your tumors are positive for PD-L1, but do
not have an abnormal EGFR or ALK gene.

Intended Use:
The KRIBIOLISA™ Nivolumab ELISA is used as an analytical tool for quantitative determination of Nivolumab
in human serum and plasma.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Nivolumab are
pre-coated onto microwells. Samples and standards are pipetted into microwells and human Nivolumab
present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase)
conjugated anti-nivolumab antibody is pipetted and incubated. After washing microwells in order to remove
any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Nivolumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.

https://krishgen.com/upload/datasheets/Nivolumab-OPDIVO-KBI1050-ver1-0-RUO.pdf

The Obinutuzumab (Gazyva) ELISA kit is intended for the quantitative determination of Obinutuzumab (Gazyva) in serum, plasma and cell culture samples. RUO only

Introduction:
Obinutuzumab is a fully humanized monoclonal antibody that binds to an epitope on CD20 that partially
overlaps with the epitope recognized by rituximab. Obinutuzumab binds to CD20 on B cells and causes these
cells to be destroyed by engaging the adaptive immune system, directly activating intracellular apoptosis
pathways, and activating the complement system.

Intended Use:
The KRIBIOLISA™ Obinutuzumab ELISA is used for quantitative detection of Obinutuzumab in serum and
plasma.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Obinutuzumab
are pre-coated onto microwells. Samples and standards are pipetted into microwells and human
Obinutuzumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish
peroxidase) conjugated Anti-Obinituzumab is pipetted and incubated. After washing microwells in order to
remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Obinutuzumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.

https://krishgen.com/upload/datasheets/KBI1058-Kribiolisa-Obinutuzumab-GAZYVA-ELISA-Insert-ver1.0.pdf

Quantitative immunoassay for Anti-Ranibizumab

The Palivizumab (Synagis) ELISA kit is intended for the quantitative determination of Palivizumab (Synagis) in serum, plasma and cell culture samples. RUO only.

Pharmacokinetics (PK) is a branch of science dedicated to the quantitative analysis of absorption, distribution, metabolism and excretion of drug molecules within the body of a living organism.

All pre-clinical and clinical studies include the measurement of serum drug concentration, both in animals and in patients, at different points after drug administration. The result is an important indicator of the drug’s pharmacokinetic properties and is pertinently relevant to dosing recommendations while developing the drug, and even while using in clinical therapy.

Krishgen PK kits are used for the quantitation of serum protein drug levels to provide accurate pharmacokinetic (PK) data that will help optimize drug dosing regimens.

About the kit:
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are 80 - 120%
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.

The Palivizumab (Synagis) ELISA kit is intended for the quantitative determination of Palivizumab (Synagis) in serum, plasma and cell culture samples. RUO only

50 ng/ml - 1000 ng/ml

Introduction:
Palivizumab is a humanized monoclonal antibody (IgG) directed against an epitope in the A antigenic site of
the F protein of RSV. It is used in the prevention of respiratory syncytial virus (RSV) infections. It is
recommended for infants that are high-risk because of prematurity or other medical problems such as
congenital heart disease.

Intended Use:
The KRIBIOLISA™ Palivizumab (Synagis™) ELISA is used for quantitative detection of Palivizumab in serum
and plasma.

Principle:
The method employs the quantitative enzyme immunoassay technique. Standards or samples are pipetted
into microwells pre-coated with Anti- Palivizumab antibody and Palivizumab present in the sample and
standards are bound by Anti- Palivizumab antibody. In the second step, Detection antidody is added
and incubated. In the third step, a HRP conjugate is pipetted and incubated. Free HRP conjugate
will be removed by washing. Addition of TMB substrate will develop blue color and intensity of blue colour in
wells is proportional to the concentration of Palivizumab present in standard or sample. Color development is
then stopped by addition of stop solution. Absorbance is measured at 450 nm.

https://krishgen.com/upload/datasheets/KBI1080-Kribiolisa-Palivizumab-Synagis-ELISA-Insert-ver1.0.pdf

The Panitumumab (Vectibix) ELISA kit is intended for the quantitative determination of Panitumumab (Vectibix) in serum, plasma and cell culture samples. RUO only

50 ng/ml - 1000 ng/ml

Introduction:
Panitumumab, is a IgG2 human monoclonal antibody specific to the epidermal growth factor receptor. EGFR is
a transmembrane protein. Panitumumab works by binding to the extracellular domain of the EGFR preventing
its activation. This results in halting of the cascade of intracellular signals dependent on this receptor.

Intended Use:
The KRIBIOLISA™ Panitumumab (Vectibix™) ELISA is used for quantitative detection of Panitumumab in
serum and plasma.

Principle:
The method employs the quantitative enzyme immunoassay technique. Standards or samples are
pipetted into microwells pre-coated with Anti- Panitumumab antibody and Panitumumab present in the
sample and standards are bound by Anti- Panitumumab antibody. In the second step, Detection
antidody is added and incubated. In the third step, a HRP conjugate is pipetted and incubated.
Free HRP conjugate will be removed by washing. Addition of TMB substrate will develop blue color and
intensity of blue colour in wells is proportional to the concentration of Panitumumab present in standard or
sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450
nm.

https://krishgen.com/upload/datasheets/KBI1082-Kribiolisa-Panitumumab-Vectibix-ELISA-Insert-ver1.0.pdf

The Pembrolizumab (Keytruda) ELISA kit is intended for the quantitative determination of Pembrolizumab (Keytruda) in serum, plasma and cell culture samples. RUO only

Introduction:
Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody used in cancer immunotherapy
that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, and cervical
cancer. Pembrolizumab was approved for medical use in the United States in 2014. In 2017, the US Food and
Drug Administration (FDA) approved it for any unresectable or metastatic solid tumor with certain genetic
anomalies (mismatch repair deficiency or microsatellite instability). It is on the World Health Organization's List
of Essential Medicines.

Intended Use:
The KRIBIOLISA™ Pembrolizumab ELISA is used as an analytical tool for quantitative determination of
Pembrolizumab in human serum and plasma.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to
Pembrolizumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and
human Pembrolizumab present in the sample are bound by the capture antibody. Then, a HRP
(horseradish peroxidase) conjugated anti-pembrolizumab antibody is pipetted and incubated. After washing
microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added
to microwells and color develops proportionally to the amount of Pembrolizumab in the sample. Color
development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/KBI1084-Kribiolisa-Pembrolizumab-Keytruda-ELISA-Insert-ver1.0.pdf

The Tremilimumab ELISA kit is intended for the quantitative determination of Tremilimumab in serum, plasma and cell culture samples. RUO only

50 ng/ml - 1000 ng/ml

Introduction:
Tremelimumab (formerly ticilimumab, CP-675,206) is a fully human monoclonal antibody against CTLA-4. It is
an immune checkpoint blocker. Cytotoxic T lymphocytes (CTLs) can recognize and destroy cancer cells.
However, there is also an inhibitory mechanism (immune checkpoint) that interrupts this destruction.
Tremelimumab turns off this inhibitory mechanism and allows CTLs to continue to destroy the cancer cells.

Intended Use:
The KRIBIOLISA™ Tremelimumab ELISA is used for quantitative detection of Tremelimumab in serum and
plasma.

Principle:
The method employs the quantitative enzyme immunoassay technique. Standards or samples are
pipetted into microwells pre-coated with Anti- Tremelimumab antibody and Tremelimumab present in the
sample and standards are bound by Anti- Tremelimumab antibody. In the second step, Detection
antidody is added and incubated. In the third step, a HRP conjugate is pipetted and incubated.
Free HRP conjugate will be removed by washing. Addition of TMB substrate will develop blue color and
intensity of blue colour in wells is proportional to the concentration of Tremelimumab present in standard or
sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450
nm.

https://krishgen.com/upload/datasheets/KBI1090-Kribiolisa-Tremelimumab-ELISA-Insert-ver1.0.pdf

The Vedolizumab (Entyvio) ELISA kit is intended for the quantitative determination of Vedolizumab (Entyvio) in serum, plasma and cell culture samples. RUO only

31.25 ng/ml  - 2000 ng/ml

Introduction:
Vedolizumab is a recombinant humanized IgG1 monoclonal antibody directed against the human lymphocyte
α4β7 integrin, a key mediator of gastrointestinal inflammation. It is used in the treatment of moderate to severe
active ulcerative colitis and Crohn's disease for patients who have had an inadequate response with, lost
response to, or were intolerant to inhibitors of tumor necrosis factor-alpha (TNF-alpha) or other conventional
therapies. By blocking its primary target, α4β7 integrin, vedolizumab reduces inflammation in the gut.

Intended Use:
The KRIBIOLISA™ Vedolizumab (ENTYVIO™) ELISA is used as an analytical tool for quantitative
determination of Vedolizumab (ENTYVIO™) in serum, plasma and cell culture supernatant.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Vedolizumab are
pre-coated onto microwells. Samples and standards are pipetted into microwells and human Vedolizumab
present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase)
conjugated anti-Vedolizumab antibody is pipetted and incubated. After washing microwells in order to remove
any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color
develops proportionally to the amount of Vedolizumab in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.

Human, Mouse and Rat Available for Customisation

https://krishgen.com/upload/datasheets/KBI1096-Vedolizumab-ENTYVIO-ver1.0-RUO.pdf

Quantitative immunoassay for Anti- Ustekinumab

Abciximab (REOPRO) ELISA for quantitative determination of Abciximab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Anti-Adalimumab

Abelacimab ELISA for quantitative determination of Abelacimab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Anti-Bevacizumab

Abituzumab ELISA for quantitative determination of Abituzumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Anti-Trastuzumab

Abrezekimab ELISA for quantitative determination of Abrezekimab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Anti-Cetuximab

Abrilumab ELISA for quantitative determination of Abrilumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Anti-Golimumab

Afasevikumab ELISA for quantitative determination of Afasevikumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Anti-Natalizumab

Alirocumab ELISA for quantitative determination of Alirocumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

https://www.krishgen.com/upload/datasheets/KRIBIOLISAT_Alirocumab_ELISA_KBI1124_ver1_1_RUO.pdf

Quantitative immunoassay for Anti-Omalizumab

Amatuximab ELISA for quantitative determination of Amatuximab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Anti-Tocilizumab

Amivantamab ELISA for quantitative determination of Amivantamab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Anti-Eculizumab

Andecaliximab ELISA for quantitative determination of Andecaliximab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Anti-Ipilimumab

Anetumab Ravtansine ELISA for quantitative determination of Anetumab Ravtansine in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Anti-Denosumab

Anifrolumab ELISA for quantitative determination of Anifrolumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Anti-Atezolizumab

Anrukinzumab ELISA for quantitative determination of Anrukinzumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Anti-Daratumumab

Apamistamab ELISA for quantitative determination of Apamistamab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Anti-Ranibizumab

Aprutumab ELISA for quantitative determination of Aprutumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Aprutumab Ixadotin ELISA for quantitative determination of Aprutumab Ixadotin in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Rituximab

Ascrinvacumab ELISA for quantitative determination of Ascrinvacumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Infliximab

Astegolimab ELISA for quantitative determination of Astegolimab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Alemtuzumab

Atinumab ELISA for quantitative determination of Atinumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Etanercept

Avdoralimab ELISA for quantitative determination of Avdoralimab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Ustekinumab

Avelumab ELISA for quantitative determination of Avelumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Adalimumab

Avizakimab ELISA for quantitative determination of Avizakimab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Bevacizumab

Axatilimab ELISA for quantitative determination of Axatilimab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Trastuzumab

Azintuxizumab ELISA for quantitative determination of Azintuxizumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Cetuximab

Azintuxizumab Vedotin ELISA for quantitative determination of Azintuxizumab Vedotin in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Golimumab

Balstilimab ELISA for quantitative determination of Balstilimab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Natalizumab

Basiliximab ELISA for quantitative determination of Basiliximab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Omalizumab

Batoclimab ELISA for quantitative determination of Batoclimab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Tocilizumab

Bavituximab ELISA for quantitative determination of Bavituximab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Eculizumab

Begelomab ELISA for quantitative determination of Begelomab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Ipilimumab

Belantamab ELISA for quantitative determination of Belantamab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Denosumab

Belantamab Mafodotin ELISA for quantitative determination of Belantamab Mafodotin in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Atezolizumab

Belimumab ELISA for quantitative determination of Belimumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Quantitative immunoassay for Daratumumab

Bemarituzumab ELISA for quantitative determination of Bemarituzumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Enzyme Immunoassay for the quantitative determination of Benralizumab in serum, plasma and cell culture supernatant

Benralizumab ELISA for quantitative determination of Benralizumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

https://www.krishgen.com/upload/datasheets/Benralizumab_KBI1183_ver1_0_RUO.pdf

Meachanism of action based reporter assay

Benufutamab ELISA for quantitative determination of Benufutamab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Bermekimab ELISA for quantitative determination of Bermekimab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Bertilimumab ELISA for quantitative determination of Bertilimumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Besilesomab ELISA for quantitative determination of Besilesomab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Bimagrumab ELISA for quantitative determination of Bimagrumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Bimekizumab ELISA for quantitative determination of Bimekizumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Birtamimab ELISA for quantitative determination of Birtamimab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Bivatuzumab ELISA for quantitative determination of Bivatuzumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Bleselumab ELISA for quantitative determination of Bleselumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Blinatumomab ELISA (BLINCYTO)

Blinatumomab (BLINCYTO) ELISA for quantitative determination of Blinatumomab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Blosozumab ELISA for quantitative determination of Blosozumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Brazikumab ELISA for quantitative determination of Brazikumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year

Briakinumab ELISA for quantitative determination of Briakinumab in human serum, plasma Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year