Established bioprocesses for producing antibodies as a basis for future planning
Established bioprocesses for producing antibodies as a basis for future planning
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DOI：
10.1007/10_014
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发表时间：
2006-01-01
期刊：
影响因子：
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通讯作者：
Farid, Suzanne S.
中科院分区：
文献类型：
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作者：
Farid, Suzanne S.
在用于人类治疗和诊断的单克隆抗体生产的早期，所使用的方法是由各个组织制定的。然而，现在关于抗体和片段的信息不断积累，这些抗体和片段是通过批准用于人类使用的工艺生产的。当潜在的基于抗体的药物数量急剧增长时，这些信息就变得可用。审查讨论了报告的生产路线、规模和达到的滴度。它确定了补料分批和灌注培养与分批培养的性能，并比较了用于诊断的抗体和抗体片段的生产过程。该分析确定了在严格法规限制新技术的行业中未来可能的生产路线。它还表明新方法需要达到什么水平的性能才能具有竞争力。
In the early years of monoclonal antibody production for human therapy and diagnosis the methods used were arrived at by individual organisations. However, there is now an accumulating body of information on antibodies and fragments that have been produced by processes approved for human use. This information is becoming available at a time when the number of potential antibody-based medicines is growing sharply.The review addresses the reported production routes, their scale and the titres achieved. It identifies the performances of fed-batch and perfusion culture versus batch culture, and compares processes for the production of antibodies for diagnosis and for antibody fragments.The analysis defines the likely routes of future production in a sector where demanding regulations constrain new technology. It also indicates what levels of performance new approaches will need to meet to be competitive.