COVID-19疫苗制剂和包装(重组)继续工艺验证

Annals of the symposium: vaccines, biopharmaceuticals, in vitro diagnosis, management, other related themes Pub Date : 2022-01-01 DOI:10.35259/isi.2022_52269

Paulo Silva, Pedro Correia, Daiane Grugel, Victor Ferreira, Rayane Gonçalves

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引用次数: 0

摘要

生产周期不到1年，共生产391批。所有被评估的变量都处于控制或警戒状态。由于这是一种新产品，可以理解的是，过程中可能存在一些变化，因此，所有这些变化将继续以季度为基础进行评估，直到完成CPV阶段3b的一年多的评估期。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Continued Process Verification for COVID-19 Vaccine Formulation and Packaging (recombinant)

period of less than 1 year of production, as 391 batches were produced. All variables evaluated are under control or on alert. As this is a new product, it is understood that some variations may be inherent to the process and therefore, all will continue to be evaluated on a quarterly basis until completing the period of one more year for the evaluation of phase 3b of the CPV.

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Annals of the symposium: vaccines, biopharmaceuticals, in vitro diagnosis, management, other related themes

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