PRECLINICAL SERVICES FOR BIOPHARMACEUTICAL PRODUCT DEVELOPMENT

生物制药产品开发的临床前服务

• 批准号: 10903687
• 负责人: PHILLIP ISHIKAWA
• 金额: $ 0.07万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10903687
• 关键词: Attenuated; Biological Products; Biotechnology; Development; Development Plans; Documentation; Evaluation; Formulation; Infectious Diseases Research; Monoclonal Antibodies; Nucleic Acids; Peptides; Plasmids; Process; Recombinant Proteins; Services; Small Interfering RNA; Translational Research; assay development; manufacture; pre-clinical; preclinical development; product development; service programs; vector

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.

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。