动物细胞培养过程PAT和在线生物检测技术

PAT and on-line biological detection technology for animal cell culture

利用动物细胞反应器大规模培养生产疫苗和抗体是现代生物医药产业的重要组成部分,这些产品在疾病管控、治疗重大疾病当中的作用是不可替代的。在过去的几十年中,动物细胞大规模培养技术已取得了长足的进步,相关产品的产量显著提高。现代生物制药对产品质量和一致性提出了更高的要求。越来越多的过程研究工作致力于提高产品质量和一致性。而一致的工艺性能和Qb D需要充分利用过程分析技术(process analytical technology,PAT)。对动物细胞培养过程的PAT应用、过程检测的类型、过程在线检测传感器和在线检测技术进行了较系统的介绍。

Large scale production of vaccines and antibodies using animal cell reactors is an important part of the modern biomedical industry. These products are irreplaceable in disease control and treatment of major diseases. In the past few decades, large-scale animal cell culture technology has made great progress, and the output of related products has been signifi cantly improved. Modern biopharmaceutic has put forward higher requirements for product quality and consistency. More and more process research work is committed to improving product quality and consistency. Consistent process performance and successful implementation of quality by design（Qb D）need to take advantage of process analysis technology（PAT）. In this paper, the application of PAT in animal cell culture＇s process, the type of process detection, the on-line detection sensor and on-line detection technology are introduced systematically.