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INTRODUCTION TO BIOTECHNOLOGY AND THE BIOTECH WORKPLACE

BASIC LABORATORY METHODS IN A REGULATED ENVIRONMENT

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LECTURE OVERVIEW

  • “Modern” Biotech
  • Various biotechnology workplaces
  • What is meant by a “laboratory”

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LECTURE OVERVIEW

  • “Modern” Biotech
  • Various biotechnology workplaces
  • What is meant by a “laboratory”

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THE ORIGIN OF “MODERN BIOTECHNOLOGY”

  • Emerged as scientists learned to manipulate DNA
  • Had major commercial impact:
    • Allowed scientists to move genes into bacteria or other cells in culture
    • Modified cells could be used to manufacture protein products
      • This is biomanufacturing
    • Biopharmaceuticals have been most commercially significant biotech products

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MANUFACTURING A PROTEIN PRODUCT WITH CELLS

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Example: Biomanufacturing of Shingrix vaccine

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INTERACTIVE WEBSITE

To see what it means to use cells to produce a product, check out this interactive website:

https://www.franklinbiologics.org/

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BIOTECHNOLOGY HAS EXPANDED GREATLY

  • Biotechnology now encompasses much more than the production of pharmaceuticals using cells
    • It includes regenerative medicine, like the use of stem cells to treat cancer

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BIOTECHNOLOGY INCLUDES:

  • New methods of creating vaccines
    • Such as mRNA vaccines used to help prevent COVID-19

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BIOTECHNOLOGY INCLUDES:

  • Methods to modify food crops
  • And much more

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LECTURE OVERVIEW

  • “Modern” Biotech
  • Various biotechnology workplaces
  • What is meant by a “laboratory”

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THERE ARE MANY BIOTECHNOLOGY WORKPLACES

  • Biotechnologists work in:
    • Laboratories
    • Agricultural fields
    • Natural areas
    • Offices
    • Greenhouses
    • Production facilities

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BIOTECHNOLOGY WORKPLACES

  • Biotechnologists work with:
    • Nucleic acids and proteins
    • Cells
    • Plants
    • Animals
    • Microorganisms
    • Instruments
    • Computers

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BIOTECHNOLOGY COMPANIES

  • Biotechnology is rooted in biological research

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  • Goal of “basic research” is to understand nature

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  • Sometimes can lead to idea for a product and a biotechnology company

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THE BIG PICTURE

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BIOTECHNOLOGY COMPANY ORGANIZATION

Units of a biotech company

    • Research and Development (R&D)
    • Production
    • Quality Assurance/ Quality Control
    • Other:
      • Technical support
      • Marketing
      • Metrology
      • Regulatory

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RESEARCH AND DEVELOPMENT

  • R&D - transforms science into a product

- All stages from earliest ideas for products to how to package the product for final sale

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  • Defining all characteristics of product development
    • What, exactly, is the product?
    • How does the product perform?
    • How is the product to be made?

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THE RESPONSIBILITIES OF RESEARCH AND DEVELOPMENT UNITS

  • Work out the basic characteristics of product and how it is to be made
    • Raw materials and suppliers
    • Process for making the product
    • Equipment - maintenance, operation, calibration
    • Product packaging and labeling
    • Stability - Expiration dates

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THE RESPONSIBILITIES OF RESEARCH AND DEVELOPMENT UNITS

  • Begin development of documentation

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Lseidman@madisoncollege.edu

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THE RESPONSIBILITIES OF RESEARCH AND DEVELOPMENT UNITS

  • Establishing methods for controlling the quality of the product
    • What features product must have
    • How QC will test the product and raw materials

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THE RESPONSIBILITIES OF RESEARCH AND DEVELOPMENT UNITS

  • Work out methods to increase the scale of production
    • “Scale up”
    • Help move from research scale to production scale

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R & D CULTURE

  • Typical research culture:
    • Change
    • Uncertainty
    • Complexity

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THE RESPONSIBILITIES OF PRODUCTION UNITS

Make products

  • Many production systems
  • Often involve cells:
    • Bacterial
    • Insect
    • Mammalian

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SMALL-SCALE PRODUCTION FACILITIES

  • Look like research laboratory, but product is not data or knowledge
    • Use flasks, beakers, lab benches
    • Small fermenters

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LARGE SCALE PRODUCTION WITH CELLS

    • Fermenters may be several stories tall
    • Controlled by computers
    • Workers perform more mechanical work

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OTHER TYPES OF PRODUCTION FACILITIES

  • Plants and animals as bioreactors
    • Greenhouses and fields as workplaces
  • Eggs
  • Plants or animals as the product
    • Barns as workplace

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COMMON FEATURES OF PRODUCTION FACILITIES

  • Make a tangible item for sale or distribution
  • Business, for profit
  • Consistency, quality are goals
  • Regulations apply

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RESPONSIBILITIES OF PRODUCTION UNITS TO MAINTAIN QUALITY

  • Consistently follow documented procedures
  • Keep records
  • Maintain equipment, large or small scale
  • Monitor processes
  • Maintain environment
  • Troubleshoot problems

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PRODUCTION CULTURE

  • Follow procedures with attention to detail
  • Handle problems – according to procedure
    • Aware of problems
    • Strive for consistency

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RESPONSIBILITIES OF QUALITY CONTROL/QUALITY ASSURANCE UNITS

  • What is “quality assurance”?
    • All the activities and people who ensure the final quality of products
      • Work a lot with documentation

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RESPONSIBILITIES OF QUALITY CONTROL/QUALITY ASSURANCE UNITS

  • What is “Quality Control”
    • Subdivision of QA, lab function
    • Follow instructions laid out by R&D team
      • Test raw materials, in-process samples, and final products
      • Test to see if meet specifications
      • Document results

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QA/QC CULTURE

  • Attention to detail
  • Judgment
  • Need to be prepared for unusual events
  • Ability to handle problems
  • Need to be willing to “fail” a product

Lseidman@madisoncollege.edu

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THE EVOLUTION OF BIOTECH COMPANIES

  • Begin with idea, often from academia (start-up)
  • Culture is R&D
    • High percentage of employees with advanced degrees
    • Few employees
    • Everyone does everything
    • Usually looking for financial resources

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THE EVOLUTION OF BIOTECH COMPANIES

  • Move into production culture once product is developed
    • More employees
      • Add regulatory people
      • Human relations people
      • Production people
      • Marketing people
    • Bigger
    • More organized

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Lseidman@madisoncollege.edu

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LECTURE OVERVIEW

  • “Modern” Biotech
  • Various biotechnology workplaces
  • What is meant by a “laboratory”

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DEFINITION OF “LABORATORY”

  • A space in which to study nature
  • Place where the product is knowledge, data, information
    • Includes research labs, testing labs

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TYPES OF LABS

  • Basic research labs
      • In academia, medical facilities, government institutes
  • Research and development labs
      • Where products are developed
  • Testing Labs

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TESTING LABS

  • Testing labs:
    • Test samples
    • Product is a test result
    • QC is type of testing lab
    • Clinical laboratories - samples from patients are tested

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  • Forensics laboratories - samples from crime scenes are tested

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  • Environmental laboratories - where samples from the environment are tested

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TESTING LABS

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WHAT ARE “BASICS”?

  • Principles/methods/ideas that apply to nearly all biotech workplaces
  • Basics apply to laboratories and also to small scale production facilities.

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TO DELVE DEEPER INTO THE TOPICS IN THIS LECTURE

  • Check out Chapters 1 and 2 in Basic Laboratory Methods for Biotechnology, 3rd Edition
    • Introduces the science of biotechnology from manipulating DNA and proteins to regenerative medicine and more
  • Check out Chapter 3 to learn more about the business of biotechnology