Cellsubstrate-财团法人医药品查验中心.PPT

4-7-2011 * Product development-a reference to check US National Institute of Allergy and Infectious Diseases-Vaccines Instruction and advise to HIV vaccine researchers Information regarding (HIV) vaccines in all aspects Preclinical master contract (HIV vaccines) Manufacture GMP pilot lots of vaccine for testing in humans, or lots for testing in nonhuman primates Perform tests for safety, immunogenicity and other preclinical testing of vaccine candidates Preparation of FDA submissions leading up to human trials 4-7-2011 * Overview of product development of a vaccine Source: US NIAID Thank you! 4-7-2011 * SPARE SLIDES 4-7-2011 * 4-7-2011 * Phase 2 3- incremental requirement PC characterization, to more detail Character(s) affected by manufacture process Batch information Comparability due to changes such as process, scale Stability data, update Manufacturing and controls, update Specification, update Phase-in validation Process validation (phase 3 or NDA) Analytical method validation (phase 3 or NDA) 4-7-2011 * Phase 1 3- incremental requirement Paul-Ehrlich-Institut 4-7-2011 * Phase 1 3- incremental requirement Paul-Ehrlich-Institut 4-7-2011 * Phase 1 3- incremental requirement Paul-Ehrlich-Institut Different role and thus point of view Scientist Contract manufacturer Sponsor Regulatory agency 4-7-2011 * Concentration of test drug Scientist If only the purified protein is potent, as expected. Concentration is not a major issue. Sponsor Concentration affects injection volume, either for animal study or clinical trial. Volume/dose for sc, id, im is less than iv, thus more concentrate formulation is required for route other than iv. Concentration affects the vaccine formulation, if adjuvant is to be used. Contract manufacturer Concentration be clarified before agreement. It depends on the capacity of the production. Process improvement or modification Timeline, cost Regulation If only the stability of produc