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Updated: Jul 6, 2026

Expression and Purification of Virus-like Particles for Vaccination
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Published on: June 2, 2016

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推动监管对话:改善疫苗生物制造的in silico模型 - - 专家会议报告

Irina Meln1, Wim Van Molle2, Mónica Perea Vélez3

  • 1European Vaccine Initiative e.V., Heidelberg, Germany.

Vaccine
|April 27, 2025
PubMed
概括

监管专家正在探索疫苗开发的减少稳定性数据,可能加快产品的可用性. 通过质量数据和主动参与支持的可靠的过程模型可以简化监管提交,并促进生物制造新工具的接受.

关键词:
化学,制造和控制 (CMC) 工作下游建模下游建模数学模型的数学模型.稳定性设计 稳定性设计稳定性建模,上游建模.不确定性 不确定性疫苗的研发工作正在进行中.

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