Preclinical Services for Antibacterial Resistance Biopharmaceutical Product Development

抗菌药物耐药性生物制药产品开发的临床前服务

• 批准号: 10934774
• 金额: $ 0.26万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-08 至 2030-09-07
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10934774
• 关键词: Attenuated; Bacterial Drug Resistance; 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，促进源自生物技术过程的材料的临床前开发，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）；以及活体、修饰活体和/或减毒实体。服务内容包括：产品开发策划与评估；检测开发和产品表征；工艺开发和制定； GMP生产；和监管 CMC 文档支持。目的是推进传染病的转化研究。