This course provides a general overview of Food and Drug Administration regulations as they pertain to the biotechnology field. Knowledge of Current Good Laboratory Practices (cGLP) and Current Good Manufacturing Practices (cGMP) is needed to work in biotechnology manufacturing and preclinical research laboratories. The course will emphasize practices of cGLP, cGMP and SOP that pertain to biopharmaceutical industry. CSU After successful completion of this course, students will be able to: Outcome 1: Explain the historical events that led to the creation of good laboratory practices (GLP), good manufacturing practices (GMP) regulations, and the Food and Drug Administration (FDA). Outcome 2: Describe how the FDA insures the safety and efficacy of drugs and biologics. Outcome 3: Describe the role of quality assurance (QA) and quality control (QC) in the development of drugs and biologics. Outcome 4: Apply principles of GLP and GMP to work in a regulated biotechnology setting.

Introduction to techniques for culturing mammalian cells, including media formulation, aseptic technique, freezing, thawing, subculturing, and maintaining cells. Theory includes maintaining proper growth conditions, preventing contamination, as well as cellular responses to DNA damage and gene expression. Practical experience includes the proper use and care of equipment for culturing cells and performing cell growth and viability assays. CSU After successful completion of this course, students will be able to: Outcome 1: Evaluate cell counts to calculate and prepare proper cell concentrations for transfers, feeding and to carry out analyses of basic cell growth and viability. Outcome 2: Describe proper and safe operation of cell culture lab equipment. Outcome 3: Analyze and discuss experimental data in industry-standard laboratory notebook format. Outcome 4: Apply knowledge of cell biology concepts to prepare and maintain cells in culture.