BLG 699 Lecture Notes - Lecture 9: Active Ingredient, Drug Discovery, Glaxosmithkline
Document Summary
Pfizer designs manufacturing line for potential vaccine (may 2020) Developed a line to mass produce a vaccine in their facility. Mrna - very difficult to manufacture (requires technical) Modifications of manufacturing sites (e. g. colder temperatures to maintain vaccine potency, equipment, methods, etc. ) Potentially producing 10 million vaccines by the end of the year. A set of policies and procedures for manufacturers of drug products. The facilities, equipment, methods, and controls for producing drugs with the intended quality. The guidelines recommended by agencies that control authorization and licensing for manufacture and sales of food, drug products and active pharmaceutical products. Quality product cannot be tested into a product. It must be designed and built into each batch of the drug products throughout all aspects of its manufacturing processes. Manufacturers are required to abide by the gmp regulatory guidelines to ensure drugs are pure (free from contaminants), consistent, safe, and effective.
