Task C2: Analytical Method, Process Development and Manufacturing for Therapeutics

生物制药产品开发服务计划提供服务，以促进源自生物技术过程的材料的临床前开发，如单抗和单抗的衍生物、重组蛋白质、多肽、基于核酸的载体(siRNA、质粒)以及活的、修饰的活的和/或减毒的实体。服务包括：产品开发规划和评估；化验开发和产品发布测试；工艺开发和配方；GMP制造；以及法规CMC文档支持。

The Biopharmaceutical Product Development Services program provides services to facilitate preclinical development of materials that are derived from biotechnology processes, such as monoclonal antibodies and derivatives of monoclonal antibodies; recombinant proteins; peptides; nucleic acid based vectors (siRNA, plasmids); and live, modified-live and/or attenuated entities. Services include: product development planning and evaluation; assay development and product release testing; process development and formulation; GMP manufacturing; and regulatory CMC documentation support.