{"title":"Planova™S20N是一种新型再生纤维素病毒去除过滤器，用于过滤具有挑战性的单克隆抗体。","authors":"Asami Inoue, Satoshi Murakami, Akika Futamura, Naoto Watanabe, Yumiko Masuda","doi":"10.1002/btpr.3533","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":8856,"journal":{"name":"Biotechnology Progress","volume":" ","pages":"e3533"},"PeriodicalIF":2.5000,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A design space for the filtration of challenging monoclonal antibodies using Planova™ S20N, a new regenerated cellulose virus removal filter.\",\"authors\":\"Asami Inoue, Satoshi Murakami, Akika Futamura, Naoto Watanabe, Yumiko Masuda\",\"doi\":\"10.1002/btpr.3533\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":8856,\"journal\":{\"name\":\"Biotechnology Progress\",\"volume\":\" \",\"pages\":\"e3533\"},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2025-01-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Biotechnology Progress\",\"FirstCategoryId\":\"5\",\"ListUrlMain\":\"https://doi.org/10.1002/btpr.3533\",\"RegionNum\":3,\"RegionCategory\":\"生物学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"BIOTECHNOLOGY & APPLIED MICROBIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biotechnology Progress","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1002/btpr.3533","RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"BIOTECHNOLOGY & APPLIED MICROBIOLOGY","Score":null,"Total":0}
A design space for the filtration of challenging monoclonal antibodies using Planova™ S20N, a new regenerated cellulose virus removal filter.
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.
期刊介绍：
Biotechnology Progress , an official, bimonthly publication of the American Institute of Chemical Engineers and its technological community, the Society for Biological Engineering, features peer-reviewed research articles, reviews, and descriptions of emerging techniques for the development and design of new processes, products, and devices for the biotechnology, biopharmaceutical and bioprocess industries.
Widespread interest includes application of biological and engineering principles in fields such as applied cellular physiology and metabolic engineering, biocatalysis and bioreactor design, bioseparations and downstream processing, cell culture and tissue engineering, biosensors and process control, bioinformatics and systems biology, biomaterials and artificial organs, stem cell biology and genetics, and plant biology and food science. Manuscripts concerning the design of related processes, products, or devices are also encouraged. Four types of manuscripts are printed in the Journal: Research Papers, Topical or Review Papers, Letters to the Editor, and R & D Notes.
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