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Application of process analytical technology to plasma-derived protein pharmaceutical manufacturing processes.

机译：过程分析技术在血浆蛋白生产过程中的应用。

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摘要

The Process Analytical Technology (PAT) guidance is a scientific and regulatory framework issued in 2004 by the U.S. Food and Drug Administration for innovating and improving the pharmaceutical industry.;The implementation of PAT in the plasma-derived protein industry has been marked with delays due to regulatory and process complexities. This thesis demonstrates that the existing regulatory environment and technological advancements provide fertile grounds for the adoption of PAT in the plasma-derived industry. The paper presents regulatory guidance, which aids in resolving regulatory hurdles and promotes the adoption of PAT to harness benefits from the elimination of costly and time-consuming sample testing, revalidations, and submission reviews. This thesis shows that the technological advancements and tools developed for the biotechnology industry can serve as a basis for the implementation of PAT in the plasma-derived industry by overcoming process complexities, controlling variability, improving process understanding and control, increasing innovation, and reducing process waste.
机译：过程分析技术（PAT）指南是美国食品和药物管理局于2004年发布的科学和法规框架，旨在创新和改善制药行业。血浆衍生的蛋白质行业中PAT的实施已被标记为延迟监管和流程的复杂性。本文证明，现有的监管环境和技术进步为在等离子体衍生行业中采用PAT提供了沃土。本文提出了监管指南，有助于解决监管障碍，并促进采用PAT来利用从消除昂贵且耗时的样本测试，重新验证和提交审查中获得的收益。该论文表明，通过克服工艺复杂性，控制可变性，提高工艺理解和控制，增加工艺创新和减少工艺，为生物技术行业开发的技术进步和工具可以作为在血浆衍生行业中实施PAT的基础。浪费。

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  • 作者

    Nalbandyan, Lilit.;

  • 作者单位

    California State University, Dominguez Hills.;

  • 授予单位 California State University, Dominguez Hills.;
  • 学科 Engineering General.;Statistics.;Health Sciences Pharmacy.
  • 学位 M.S.
  • 年度 2014
  • 页码 89 p.
  • 总页数 89
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 现代史（1917年~）;
  • 关键词

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