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Biotechnology and the Workplace. 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
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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)
Organization of a Biotech Company • 1. Research and Development • 2. Production • 3. Quality Control / Quality Assurance • 4. “Other” departments
“Other” departments • - facilities management (engineering) • - maintenance and housekeeping • - receiving and shipping • - dispensing • - metrology • - marketing and sales
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.
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.)
Correct Documentation • Bound notebook: pages should not be removed or rewritten • Pages numbered consecutively. • All entries in BLACK ink. • Legible, clear and complete in your writing. • All observations and data must be entered immediately in notebook (not on scrap of paper or your hand!) • Do NOT use white-out or similar product! Cross out errors with a single line, date and initial when entry was corrected. • Be honest. Never obscure, erase or ignore a mistake. • Include detailed info about equipment, reagents, samples etc. • Store notebook in a secure location.
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)
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
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.
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.
Controversy? • Balance of safety and efficacy against cost of attaining those goals. • Thalidomide (Frances Kelsey case) • Vioxx FDA information on Vioxx (rofecoxib) • Celebrex • Ephedra • Products are regulated on their “basis of risk”.
(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.
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.
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 – 1st 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.
(2) Regulation of food and agricultural products • Regulations pertain to safety, purity, labeling and “wholesomeness”. • Regulating Federal agencies are: • USDA: United States Department of Agriculture • FDA: Food and Drug Administration • EPA: Environmental Protection Agency
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)
Biotechnology products in the food industry • 1st recombinant DNA food ingredient was chymosin(renin) in 1990. • Other genetically modified foods…..taco chips, vegetables (tomatoes, carrots), soy products etc. • 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??