Task 9: Product Validation - Biopharmaceutical Product Development Services program

针对传染病的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 for infectious diseases 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.