Task V06: Process development and manufacture of cGMP compliant parvovirus B19 vaccine drug product for use in Phase I/II clinical trials

任务 V06：用于 I/II 期临床试验的符合 cGMP 的细小病毒 B19 疫苗药品的工艺开发和制造

• 批准号: 10001092
• 负责人: TIMOTHY FOUTS
• 金额: $ 209.37万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-15 至 2028-05-14
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10001092
• 关键词: Adjuvant; Biological; Clinical Research; Clinical Trials; Communicable Diseases; Contracts; Cyclic GMP; Development; Development Plans; Human Parvovirus B19; Pharmaceutical Preparations; Phase; Process; Services; System; United States Food and Drug Administration; Vaccines; novel vaccines; product development; vaccine candidate; vaccine delivery

The Manufacture and Characterization Services (MCS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of services spanning product development planning and feasibility assessments; product optimization; product development and cGMP compliant manufacture for Phase I/II clinical 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 a wide array of infectious diseases. This contract also provides for manufacture of candidate vaccines, vaccine components including adjuvants, vaccine delivery systems, other biologics, and challenge material.

传染病疫苗和其他生物制剂的生产和表征服务（MCS）合同提供各种服务，包括产品开发规划和可行性评估;产品优化;产品开发和I/II期临床研究的cGMP合规生产;技术和设施审计;以及适用于提交给美国食品药品监督管理局（FDA）的监管支持。 这些服务将促进开发和引进新的疫苗和生物制剂，以防治各种传染病。 该合同还规定了候选疫苗、疫苗组分（包括佐剂）、疫苗输送系统、其他生物制剂和挑战材料的生产。