TASK V31: PROCESS DEVELOPMENT FOR PANFUNGAL VACCINES

任务 V31：全真菌疫苗的工艺开发

• 批准号: 10888432
• 负责人: TIM FOUTS
• 金额: $ 47.76万
• 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: 2023-01-20 至 2028-05-14
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10888432
• 关键词: Antimicrobial Resistance; Biological Products; Bioterrorism; Candida auris; Clinical Research; Communicable Diseases; Contracts; Cyclic GMP; Development; Development Plans; Drug resistance; Emerging Communicable Diseases; Phase; Process; Services; Toxicology; United States Food and Drug Administration; Vaccines; manufacture; novel vaccines; pathogenic fungus; 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 and emerging and re-emerging infectious diseases.

传染病合同的疫苗和其他生物制剂的制造和表征服务（MCS）提供了各种产品开发服务，涵盖了产品开发计划和可行性评估； I/II期临床研究的产品开发和CGMP符合CGMP的制造；毒理学研究；技术和设施审核；以及适合向美国食品药品监督管理局（FDA）提交的监管支持。 这些服务将有助于开发和引入新的疫苗和生物制剂，以针对生物恐怖主义的潜在药物以及新兴和重新出现的传染病。