PRECLINICAL SERVICES FOR BIOPHARMACEUTICAL PRODUCT DEVELOPMENT

生物制药产品开发服务计划提供服务，以促进生物技术过程中衍生材料的临床前开发，例如单克隆抗体和单克隆抗体衍生物;重组蛋白;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：产品开发计划和评估;检测开发和产品表征;工艺开发和配方; GMP生产;以及CMC法规文件支持。其目的是为传染病进行先进的转化研究。

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 characterization; process development and formulation; GMP manufacturing; and regulatory CMC documentation support. The aim is advance translational research for infectious diseases.