1. THE BIOTECHNOLOGY WORKPLACE

2. lseidman@matcmadison.edu OVERVIEW Biotechnology workplaces Laboratories

3. lseidman@matcmadison.edu 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

4. lseidman@matcmadison.edu LIFE CYCLE OF A PRODUCT Discovery – from research laboratories Research and DEVELOPMENT  Pharmaceuticals have a particularly long and complex development cycle Production

5. lseidman@matcmadison.edu BIOTECHNOLOGY COMPANY ORGANIZATION Research and Development Production Quality Assurance/ Quality Control Other:  Technical support  Marketing  Metrology

6. lseidman@matcmadison.edu ROOTS OF BIOECHNOLOGY COMPANIES Biotechnology has deep roots in academic biological research

7. lseidman@matcmadison.edu 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

8. lseidman@matcmadison.edu RESEARCH AND DEVELOPMENT R&D -- transforms science into a product

9. lseidman@matcmadison.edu DEVELOPMENT  All stages from earliest ideas for products to how to package the product for final sale.

10. lseidman@matcmadison.edu DEVELOPMENT What, exactly, is the product? How does the product perform? How is the product to be made?

11. lseidman@matcmadison.edu R&D TEAM BEGINS DOCUMENTATION Documentation- Standard Operating Procedures - Batch records, etc.

12. lseidman@matcmadison.edu 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

13. lseidman@matcmadison.edu FIGURE OUT How QC will test the product and raw materials Method validation for testing

14. lseidman@matcmadison.edu SCALE UP IS PART OF DEVELOPMENT Move from research scale to production scale Validation of processes

15. lseidman@matcmadison.edu R & D CULTURE Typical research culture: Change Uncertainty Complexity

16. lseidman@matcmadison.edu NEXT PHASE: PRODUCTION Make products Many production systems Often involve cells:  Bacterial  Insect  Mammalian

17. lseidman@matcmadison.edu 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

18. LARGE SCALE PRODUCTION WITH CELLS Looks quite different Fermenters may be several stories tall Controlled by computers

19. lseidman@matcmadison.edu OPERATORS IN LARGE SCALE PRODUCTION SETTING Work with valves, pipes, large size equipment Work is quite different than in laboratory

20. lseidman@matcmadison.edu OTHER PRODUCTION Plants and animals as bioreactors Eggs Plants or animals as the product

21. lseidman@matcmadison.edu SO, THERE ARE MANY PRODUCTION SETTINGS Greenhouse Clean room Field Barn Fermentation facilities

22. lseidman@matcmadison.edu 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

23. lseidman@matcmadison.edu PRODUCTION OPERATORS Follow documented procedures to make products Keep records Maintain consistency Maintain equipment, large or small scale Monitor processes Maintain environment

24. lseidman@matcmadison.edu PRODUCTION CULTURE Follow procedures without deviation Attention to detail Handle problems – according to procedure Aware of problems Strive for consistency

25. lseidman@matcmadison.edu QUALITY CONTROL/QUALITY ASSURANCE Quality assurance: all the activities and people who ensure the final quality of products Documentation Regulatory affairs

26. lseidman@matcmadison.edu 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

27. lseidman@matcmadison.edu QA/QC CULTURE Attention to detail Judgment Need to be prepared for unusual events Handle problems Need to be willing to “fail” a product

28. lseidman@matcmadison.edu 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

29. lseidman@matcmadison.edu High percentage of employees with advanced degrees Few employees Everyone does everything Often poor, looking for investment

30. lseidman@matcmadison.edu A SUCCESSFUL COMPANY MOVES TOWARDS PRODUCTION OF A PRODUCT Culture changes More employees Add regulatory people Human relations people Production people Marketing people Bigger More organized

31. lseidman@matcmadison.edu 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

32. lseidman@matcmadison.edu 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

33. lseidman@matcmadison.edu TESTING LABS Test samples Product is a test result QC is type of testing lab

34. lseidman@matcmadison.edu OTHER TESTING LABS Clinical laboratories -- samples from patients are tested

35. lseidman@matcmadison.edu Forensics laboratories -- samples from crime scenes are tested

36. lseidman@matcmadison.edu Environmental laboratories -- where samples from the environment are tested

37. lseidman@matcmadison.edu 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.