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首页> 外文会议>Regulatory sciences for biologics and vaccines: accelerating development and enabling manufacturing innovation >PLATFORMS PREPARE MANUFACTURING FOR RAPID RESPONSE
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PLATFORMS PREPARE MANUFACTURING FOR RAPID RESPONSE

机译：平台准备快速响应的制造

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Recent outbreaks have created an awareness of the complexity of manufacturing vaccines and therapeutics in time to address an emerging infectious disease threat. Emergent BioSolutions, as an HHS/ASPR/BARDA (Biodefense Advanced Research and Development Authority) Center for Innovation in Advanced Development and Manufacturing (CIADM), facilitates advanced development of chemical, biological, radiological, and nuclear (CBRN) medical countermeasures and ensures domestic manufacturing surge capacity to address the US government's preparedness priorities and needs. Emergent has a broad range of vaccine manufacturing experience and has been evaluating and implementing processes for the rapid manufacture of vaccines and therapeutics to address these events. For products in pre-clinical development, the use of an expression system with an established manufacturing platform greatly reduces time to initiate manufacturing and increases the probability of success. In addition, platform processes allow for some in-process and release tests to be developed and ready for implementation. However, success is still not guaranteed as challenges with purity, potency, yield and stability may still be encountered. While some of these challenges can be overcome by approaches such as developing and validating platforms, additional challenges may still be present such as availability of testing and fill/finish facilities and preparation and agreement on necessary legal and regulatory documents. Timelines for manufacture are still several months at the minimum and may take significantly longer. Preparing platforms for the response to a potential infectious disease outbreak in advance is the best way to have effective vaccines and therapeutics ready to counter it.
机译：最近的暴发使人们意识到及时制造疫苗和治疗剂的复杂性以应对新出现的传染病威胁。作为HHS / ASPR / BARDA（生物防御高级研究与开发局）先进开发与制造创新中心（CIADM），Emergent BioSolutions促进了化学，生物，放射和核医学（CBRN）医疗对策的先进开发，并确保了国内制造业激增的能力可以解决美国政府的备灾重点和需求。 Emergent拥有广泛的疫苗生产经验，并一直在评估和实施快速生产疫苗和治疗剂的方法来解决这些问题。对于临床前开发的产品，使用具有已建立的生产平台的表达系统可大大减少启动生产的时间，并增加成功的可能性。此外，平台流程允许开发一些进行中的测试和发布测试，并准备实施。但是，仍然不能保证成功，因为仍然可能会遇到纯度，效能，产率和稳定性方面的挑战。尽管可以通过诸如开发和验证平台之类的方法来克服其中的一些挑战，但仍然可能存在其他挑战，例如测试和填充/完成设施的可用性以及就必要的法律和法规文件进行准备和达成协议。制造时间表至少还需要几个月，并且可能需要更长的时间。预先准备应对潜在传染病暴发的平台，是准备有效疫苗和治疗剂以应对疾病的最佳方法。

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