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Review Trends in biotechnology. 2025 Mar 27:S0167-7799(25)00079-4. doi: 10.1016/j.tibtech.2025.02.016 Q114.32024

Process and quality considerations for recombinant adeno-associated virus manufacturing platforms

重组腺相关病毒生产平台的工艺和质量考量因素 翻译改进

Min Tae Park  1, Amrisha Verma  1, Clifford A Froelich  1, Seyed Pouria Motevalian  2

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作者单位

  • 1 BioProcess Sciences, Pharma Services, Viral Vector Services, Thermo Fisher Scientific, Plainville, MA 02762, USA.
  • 2 BioProcess Sciences, Pharma Services, Viral Vector Services, Thermo Fisher Scientific, Plainville, MA 02762, USA. Electronic address: pouria.motevalian@thermofisher.com.
  • DOI: 10.1016/j.tibtech.2025.02.016 PMID: 40148137

    摘要 Ai翻译

    Recombinant adeno-associated virus (AAV) is a prominent gene therapy vector, offering a strong safety profile and sustained gene expression. Scaling up AAV manufacturing remains challenging due to its complex processes, high development costs, and the need for rigorous quality control. This review examines the most common AAV suspension production platforms, specifically transfection, infection, and stable producer cell lines (PCLs). For each platform, a list of common unit operations and typical ranges for critical operating parameters is provided, along with high-level product quality specifications. This review aims to offer insights into the advantages and challenges of each manufacturing platform, providing a framework for accelerated process development and informed selection of suitable production platform based on intended clinical use and target product profile.

    Keywords: adeno-associated virus; baculovirus infection; gene therapy; producer cell line; transfection.

    Keywords:manufacturing platforms; quality considerations

    Copyright © Trends in biotechnology. 中文内容为AI机器翻译,仅供参考!

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    期刊名:Trends in biotechnology

    缩写:TRENDS BIOTECHNOL

    ISSN:0167-7799

    e-ISSN:1879-3096

    IF/分区:14.3/Q1

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    Process and quality considerations for recombinant adeno-associated virus manufacturing platforms