Task X16: Fecal Microbiota for Transplantation (FMT) Process Development

任务 X16：用于移植 (FMT) 工艺开发的粪便微生物群

• 批准号: 10926783
• 负责人: JAMES RICHARDSON
• 金额: $ 0.94万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-21 至 2020-05-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10926783
• 关键词: Antimicrobial Resistance; Biological Products; Bioterrorism; Clinical Research; Clostridium difficile; Communicable Diseases; Contracts; Cyclic GMP; Development; Development Plans; Emerging Communicable Diseases; Phase; Process; Services; Toxicology; United States Food and Drug Administration; Vaccines; drug resistant pathogen; fecal transplantation; manufacture; novel vaccines; product development; vaccine development

The Manufacture and Characterization Services (MCS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of product development services spanning product development planning and feasibility assessments; product development and cGMP compliant manufacture for Phase I/II clinical studies; toxicology studies; technical and facility audits; and regulatory support appropriate for submission to the U.S. Food and Drug Administration (FDA). These services will facilitate the development and introduction of new vaccines and biologics against potential agents of bioterrorism, drug-resistant pathogens, and emerging and re-emerging infectious diseases. This contract also provides for manufacture of challenge material.

疫苗和其他传染病生物制剂的制造和表征服务 (MCS) 合同提供各种产品开发服务，涵盖产品开发规划和可行性评估； I/II 期临床研究的产品开发和符合 cGMP 的生产；毒理学研究；技术和设施审核；以及适合提交给美国食品和药物管理局 (FDA) 的监管支持。 这些服务将促进新疫苗和生物制剂的开发和引进，以应对潜在的生物恐怖主义、耐药病原体以及新出现和重新出现的传染病。 该合同还规定了挑战材料的制造。