Task V33: Manufacturing of Master Cell Bank Production and Formulation Development for Antibacterial resistance

任务V33：主细胞库生产的制造和抗菌药物耐药性的制剂开发

• 批准号: 10937160
• 负责人: CHRISTINE MEYER
• 金额: $ 44.33万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-26 至 2024-09-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10937160
• 关键词: Adjuvant; Bacterial Drug Resistance; Biological Products; Candida; Clinical Research; Communicable Diseases; Contracts; Cyclic GMP; Development; Development Plans; Formulation; Phase; Production; Services; System; United States Food and Drug Administration; Vaccines; cell bank; fungus; manufacture; novel vaccines; pathogen; product development; vaccine delivery; vaccine development

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 antibacterial resistant pathogens. This contract also provides for manufacture of 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针对抗菌耐药病原体的新疫苗和生物制剂。 该合同还规定了疫苗、疫苗成分（包括佐剂）、疫苗输送系统、其他生物制剂和攻毒材料的生产。