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

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
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
已结题
起止时间:
2023-09-26 至 2024-09-25

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中文摘要
翻译
传染病疫苗和其他生物制品的生产和表征服务(MCS)合同提供了涵盖产品开发规划和可行性评估的各种服务;产品优化;I/II期临床研究的产品开发和符合cGMP的生产;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。这些服务将促进开发和引进针对耐抗菌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)、疫苗递送系统、其他生物制剂和挑战材料的生产。
英文摘要
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.
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