Development of a Monoclonal Antibody Against NIpah and Hendra Viruses

抗 Nipah 和 Hendra 病毒单克隆抗体的开发

• 批准号: 8563812
• 金额: $ 2.02万
• 依托单位: SCIENCE APPLICATIONS INTERNATIONAL CORP
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-14 至 2012-11-23
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8563812
• 关键词: Antibodies; Attenuated; Biological Products; Biotechnology; Development; Development Plans; Documentation; Drug Formulations; Evaluation; Hendra Virus; Life; Monoclonal Antibodies; Nipah Virus; Nucleic Acids; Peptides; Plasmids; Process; Recombinant Proteins; Services; Small Interfering RNA; Testing; assay development; base; pre-clinical; product development; 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 release testing; process development and formulation; GMP manufacturing; and regulatory CMC documentation support.

生物制药产品开发服务项目提供服务，以促进来自生物技术过程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。