1. Biotechnology and the Workplace

2. Roles for Biomedical scientists Laboratory technicians: - Healthcare or clinical labs (CLS, MLT) - Research laboratories (government labs, university or non-for-profit facilities, private companies) - Pharmaceutical companies - Biotechnology companies (R&D, production, QA/QC)

3. Organization of a Biotech Company  1. Research and Development  2. Production  3. Quality Control / Quality Assurance  4. “Other” departments

4. “Other” departments  - facilities management (engineering)  - maintenance and housekeeping  - receiving and shipping  - dispensing  - metrology  - marketing and sales

5. Documentation  1. Laboratory Notebooks: primary document of record, legal document. 2. Standard Operating Procedures (SOPs): step-by step outline of how a task is to be performed, regularly updated.  3. Protocol: describes how to perform a task to answer a hypothesis or question.  4. Instrument logbooks: chronological record of status and maintenance for an instrument/equipment.

6. 5. Reports: describes the results of an executed protocol, with summary, technician name, conclusions etc.  6. Electronic documentation: computer analysis, tabulation, databases etc.  7. Identification numbers: used for documents, equipment, raw materials, chemicals etc.  8. Training reports: shows type of training, dates etc. (In Production facilities only: Batch Records and Final Product Release Records are also required.)

7. Correct Documentation 1. Bound notebook: pages should not be removed or rewritten 2. Pages numbered consecutively. 3. All entries in BLACK ink. 4. Legible, clear and complete in your writing. 5. All observations and data must be entered immediately in notebook (not on scrap of paper or your hand!) 6. Do NOT use white-out or similar product! Cross out errors with a single line, date and initial when entry was corrected. 7. Be honest. Never obscure, erase or ignore a mistake. 8. Include detailed info about equipment, reagents, samples etc. 9. Store notebook in a secure location.

8. Laboratory Safety  A number of state, federal and local agencies regulate safety and environmental protection in clinical, pharmaceutical and academic labs.  Occupational Health and Safety Administration (OSHA):  Environmental Protection Agency (EPA)  Department of Transportation (DOT)  Nuclear Regulatory Commission (NRC)

9. Chemical Hygiene Plan  Institutional Policies and Procedures to address: - general chemical safety rules - purchase, distribution and storage of chemicals - environmental monitoring - availability of medical programs - record keeping policies - training and employee information programs - availability of protective devices and clothing - accident and spill policies - waste disposal programs

10. Material Safety Data Sheet (MSDS).  Labeling of hazardous chemicals is required under HCS and an MSDS must be available for every chemical in the lab.  MSDS is a technical document describing the specific properties of a chemical. For example: chemical name, supplier, potential health effects, exposure levels, handling and storage procedures, toxicological data, disposal recommendation, regulatory recommendations etc.

11. GLP, GMP, GCP and FDA regulations

12. Regulation of Medical and Food Products Regulations relate to: (1) safety, (2) honesty in labeling and (3) effectiveness and reliability.  FDCA (Food, Drug and Cosmetics Act)   CFR (Code of Federal Regulations)   FDA also publishes Guidelines, not enforced by law but should be followed by the company.

13. Controversy?  Balance of safety and efficacy against cost of attaining those goals.  Thalidomide (Frances Kelsey case)  Vioxx FDA information on Vioxx (rofecoxib)FDA information on Vioxx (rofecoxib)  Celebrex  Ephedra  Products are regulated on their “basis of risk”.

14. (1) Regulation of medical products  2 separate regulatory systems within the FDA  Center for Drug Evaluation and Research (CDER): Includes antibiotics and other products of microbial metabolism produced by fermentation, compounds produced by chemical synthesis and hormones extracted from animal tissues (e.g.. insulin)  Center for Biologics Evaluation and Research (CBER): includes products extracted from human or animal plasma, vaccines produced from microbes, and viruses and allergens extracted from animal sources.

15. GMP, GLP and GCP.  “Drugs” and “biologics” must be produced using GMP and are subject to scrutiny for safety and efficacy.  FDA also instituted GLP to govern animal studies of pharmaceutical products i.e. correct documentation practices must be followed (written protocols, SOPs etc). GMP: good manufacturing practices GLP: good laboratory practices. GCP: good clinical practices.

16. Good Clinical Practices. If a product is safe in animal studies then clinical trials can be planned. GCP relate to the performance of clinical trials of drug safety and efficacy in human subjects.  Phase I – 1 st introduction of proposed drug into humans.  Phase II – performed on a small # of diseased patients to determine the drugs efficacy.  Phase III – involves more patients.  If successful an NDA is submitted to the FDA.NDA

17. (2) Regulation of food and agricultural products  Regulations pertain to safety, purity, labeling and “wholesomeness”.  Regulating Federal agencies are: 1. USDA: United States Department of Agriculture 2. FDA: Food and Drug Administration 3. EPA: Environmental Protection Agency

18. Major issues related to food safety include: - Avoiding contamination by pathogens (bacteria, parasites), - Minimizing adverse effects of unintentional additives (e.g.. pesticides) - Minimizing the effect of intentional additives (e.g.. coloring agents and sweeteners)

19. Biotechnology products in the food industry  1 st recombinant DNA food ingredient was chymosin(renin) in 1990.chymosin  Other genetically modified foods…..taco chips, vegetables (tomatoes, carrots), soy products etc.taco chipstomatoessoy products  Genetically modified organisms…  resistance to herbicides, insects or viruses.  A special review is only required if, (1) the product can cause an allergic reaction or (2) has a different nutritional value.  Controversial??