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生物制造业高效技术转让的QbD框架

Dogan Ornek1

  • 1Process Sciences and Development, Boston Institute of Biotechnology, Southborough, MA, USA don.ornek@bostonbib.com.

PDA journal of pharmaceutical science and technology
|January 30, 2026
PubMed
概括

实施设计质量 (QbD) 原则简化了客户和合同组织之间的技术转让. 这种系统的方法提高了效率,缩短了时间表,并确保了监管合规的产品质量一致.

关键词:
生物制品 制造业 制造业在CDMO CDMO中使用.有效的技术转让.美国联邦航空和航空管理局 (FMEA) 的FMEAEAEA.通过设计的质量.关于征求建议的要求工作范围的工作范围.

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