THE BIOTECHNOLOGY WORKPLACE. [email protected] OVERVIEW Biotechnology workplaces...
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THE BIOTECHNOLOGY WORKPLACE
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Transcript of THE BIOTECHNOLOGY WORKPLACE. [email protected] OVERVIEW Biotechnology workplaces...
THE BIOTECHNOLOGY WORKPLACE
NOT JUST ONE BIOTECHNOLOGY WORK PLACE Laboratory, field, office,
greenhouses, fermentation production facilities
Work with whole plants, whole animals, cells, microorganisms, instruments, computers
Academic, government, private company
LIFE CYCLE OF A PRODUCT
Discovery – from research laboratories
Research and DEVELOPMENT Pharmaceuticals have a particularly
long and complex development cycle
Production
BIOTECHNOLOGY COMPANY ORGANIZATION
Research and Development Production Quality Assurance/
Quality Control Other:
Technical support Marketing Metrology
ROOTS OF BIOECHNOLOGY COMPANIES Biotechnology has deep
roots in academic biological research
BEGINS WITH BASIC RESEARCH
Before there is R&D, there is basic research
Typically in academia
Goal of basic research is to understand nature
May lead to idea for a biotechnology company
DEVELOPMENT
All stages from earliest ideas for products to how to package the product for final sale.
DEVELOPMENT
What, exactly, is the product?
How does the product perform?
How is the product to be made?
R&D TEAM BEGINS DOCUMENTATION
Documentation- Standard Operating Procedures - Batch records, etc.
R&D TEAMS FIGURES OUT
Raw materials and suppliers Process for making the
product Equipment - maintenance,
operation, calibration Product packaging and
labeling Stability - Expiration dates
FIGURE OUT
How QC will test the product and raw materials
Method validation for testing
SCALE UP IS PART OF DEVELOPMENT
Move from research scale to production scale
Validation of processes
NEXT PHASE: PRODUCTION
Make products Many production systems Often involve cells:
Bacterial Insect Mammalian
SMALL SCALE PRODUCTION
Flasks, beakers, lab benches Small fermenters Looks like research laboratory,
but product is not data or knowledge
Much of what we say this week applies to small scale production
LARGE SCALE PRODUCTION WITH CELLS Looks quite different Fermenters may be several
stories tall Controlled by computers
OPERATORS IN LARGE SCALE PRODUCTION SETTING Work with valves, pipes,
large size equipment Work is quite different than in
laboratory
OTHER PRODUCTION
Plants and animals as bioreactors
Eggs Plants or animals as the
product
SO, THERE ARE MANY PRODUCTION SETTINGS Greenhouse Clean room Field Barn Fermentation facilities
BUT ARE COMMONALITIES
Production is: Where make a tangible item
for sale or distribution Business, where $$$ are Consistency, quality are
goals Change is challenging Regulations apply
PRODUCTION OPERATORS
Follow documented procedures to make products
Keep records Maintain consistency Maintain equipment, large or
small scale Monitor processes Maintain environment
PRODUCTION CULTURE
Follow procedures without deviation
Attention to detail Handle problems –
according to procedure Aware of problems Strive for consistency
QUALITY CONTROL/QUALITY ASSURANCE
Quality assurance: all the activities and people who ensure the final quality of products
Documentation Regulatory affairs
QUALITY CONTROL
Subdivision of QA, lab function
Follow instructions laid out by R&D team
Raw materials, in-process samples, and final products are tested
Test if meet specifications Document results
QA/QC CULTURE
Attention to detail Judgment Need to be prepared for
unusual events Handle problems Need to be willing to “fail” a
product
A “TYPICAL”BIOTECHNOLOGY COMPANY EVOLVES Cultures evolve New company is called a
start-up company Begin with idea, often from
professor in university Company is heavily invested
in R&D Culture is R&D
High percentage of employees with advanced degrees
Few employees Everyone does everything Often poor, looking for
investment
A SUCCESSFUL COMPANY MOVES TOWARDS PRODUCTION OF A PRODUCTCulture changes More employees Add regulatory people Human relations people Production people Marketing people Bigger More organized
MORE ABOUT LABORATORIES
We are interested mostly in the laboratory side of biotechnology
There are: Basic research labs in
academia, medical facilities, government, institutes
R&D labs where products are developed
Quality control labs
WHAT IS A LABORATORY?
A space in which to study nature
Place where the product is knowledge, data, information
In addition to research labs, testing labs
BASICS
Most of what we say in this course applies to all forms of labs.
Applies to academic research and company settings.
Applies to small scale biotech production also.
