Inoue Asami, Murakami Satoshi, Futamura Akika, Watanabe Naoto, Masuda Yumiko
Technology Development Department, Bioprocess Division, Asahi Kasei Medical Co., Ltd, Nobeoka, Miyazaki, Japan.
Biologics Technology Research Laboratories, Biologics Division, Daiichi Sankyo Co., Ltd, Oura-gun, Gunma, Japan.
Biotechnol Prog. 2025 May-Jun;41(3):e3533. doi: 10.1002/btpr.3533. Epub 2025 Jan 23.
Virus removal by filtration is a crucial step in ensuring the safety of therapeutic antibodies and other biopharmaceutical products by mitigating the risk of endogenous and adventitious viral contamination. However, there are monoclonal antibodies (mAb) that are difficult to filter effectively using virus removal filters (i.e., challenging mAbs), necessitating the creation of guidelines for designing suitable filtration conditions for these challenging molecules. This study presents a filtration design space for filtration conditions using a new regenerated cellulose membrane filter with a representative challenging mAb. The filter demonstrated that filtration throughput is adaptable across a wide range of conditions for low to medium mAb concentrations, indicating its suitability for introduction into platform processes for related biopharmaceutical products.
通过过滤去除病毒是确保治疗性抗体和其他生物制药产品安全的关键步骤，可降低内源性和外来病毒污染的风险。然而，存在一些单克隆抗体（mAb）难以使用病毒去除过滤器进行有效过滤（即具有挑战性的mAb），因此需要制定为这些具有挑战性的分子设计合适过滤条件的指南。本研究使用具有代表性的具有挑战性的mAb，通过新型再生纤维素膜过滤器展示了过滤条件的设计空间。该过滤器表明，对于低至中等mAb浓度，过滤通量在广泛的条件下具有适应性，表明其适合引入相关生物制药产品的平台工艺中。
