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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.<\/jats:p>","DOI":"10.1002\/btpr.3533","type":"journal-article","created":{"date-parts":[[2025,1,23]],"date-time":"2025-01-23T07:39:45Z","timestamp":1737617985000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["A design space for the filtration of challenging monoclonal antibodies using\n                    <scp>Planova\u2122 S20N<\/scp>\n                    , a new regenerated cellulose virus removal filter"],"prefix":"10.1002","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-6832-5513","authenticated-orcid":false,"given":"Asami","family":"Inoue","sequence":"first","affiliation":[{"name":"Technology Development Department, Bioprocess Division Asahi Kasei Medical Co., Ltd  Nobeoka Miyazaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Murakami","sequence":"additional","affiliation":[{"name":"Biologics Technology Research Laboratories, Biologics Division Daiichi Sankyo Co., Ltd  Oura\u2010gun Gunma Japan"},{"name":"Graduate School of Horticulture Chiba University  Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akika","family":"Futamura","sequence":"additional","affiliation":[{"name":"Scientific Affairs Group, Bioprocess Division Asahi Kasei Medical Co., Ltd  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoto","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Scientific Affairs Group, Bioprocess Division Asahi Kasei Medical Co., Ltd  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yumiko","family":"Masuda","sequence":"additional","affiliation":[{"name":"Biologics Technology Research Laboratories, Biologics Division Daiichi Sankyo Co., Ltd  Oura\u2010gun Gunma Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,1,23]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.4161\/19420862.2015.989042"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.2217\/imt.12.38"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600\u2010065X.2008.00601.x"},{"key":"e_1_2_10_5_1","unstructured":"ICH.International conference on harmonisation tripartite guideline.2023Accessed March 13 2024.https:\/\/database.ich.org\/sites\/default\/files\/ICH_Q5A%28R2%29_Guideline_2023_1101.pdf"},{"key":"e_1_2_10_6_1","volume-title":"Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products","author":"Committee for Medicinal Products for Human Use","year":"2008"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11157\u2010017\u20109434\u20101"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10570\u2010021\u201004319\u20102"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/btpr.415"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/btpr.533"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/btpr.2506"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/btpr.3237"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/btpr.3420"},{"key":"e_1_2_10_14_1","unstructured":"YoshidaM NakashimaS HimenoS KajiyamaK.Porous hollow\u2010fiber membrane and method for testing integrity. 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