Task 9: Product Validation - Biopharmaceutical Product Development Services program

传染病生物制药产品开发服务项目提供服务，促进从生物技术过程中获得的材料的临床前开发，如单克隆抗体和单克隆抗体的衍生物；重组蛋白;肽;核酸载体（siRNA、质粒）；以及活的，被修改的活的和/或弱化的实体。服务内容包括：产品开发策划与评估；分析开发和产品释放测试；工艺开发和制定；GMP制造;监管CMC文件支持。

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.