{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T06:47:53Z","timestamp":1792392473965,"version":"4.4.0"},"reference-count":32,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T00:00:00Z","timestamp":1792281600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T00:00:00Z","timestamp":1792281600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biotech &amp;amp; Bioengineering"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Monoclonal antibody downstream processing often requires multiple pH adjustments between Protein A capture and polishing steps. These adjustments increase process complexity and make direct unit\u2010operation connection more difficult. We evaluated a connected post\u2010capture polishing block operated at approximately pH 5.0 using mild\u2010pH Protein A elution, an acidic\u2010window anion exchange (AEX) membrane, and cation exchange (CEX) chromatography. Praesto Jetted A50 HipH generated IgG1 eluates near pH 5.0 with conductivity suitable for direct AEX loading. Under standard condition (pH 5.0, 5.0 mS\/cm), the AEX membrane reduced xenotropic murine leukemia virus to the assay limit (\u2265\u20093 log10) and minute virus of mice by approximately 2\u20133 log10. In a connected proof\u2010of\u2010concept run without intermediate pH adjustment, the AEX\u2013CEX polishing block reduced host cell proteins from &gt;\u200925 to &lt;\u200910\u2009ng\/mg\u2010IgG and high\u2010molecular\u2010weight species from 1.3% to &lt;\u20091% in the final product pool, maintained low\u2010molecular\u2010weight species below 1%, and achieved 97.6% product recovery. For two additional IgGs, archived strong\u2010AEX flow\u2010through records at pH 7.5 and sequence\u2010derived charge descriptors supported the plausibility of product flow\u2010through at pH 5.0. In a same\u2010IgG1 retrospective comparison, the connected configuration used fewer vessels and conditioning operations and had shorter recipe\u2010derived programmed chromatography time. These findings support process\u2010representative evaluation of single\u2010pH connected polishing.<\/jats:p>","DOI":"10.1002\/bit.70415","type":"journal-article","created":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T06:37:55Z","timestamp":1792391875000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Feasibility Assessment of a Single\u2010pH Connected Polishing Train for Monoclonal Antibody Purification Using Mildly Acidic Protein A Elution and an Acidic\u2010Window Anion Exchange Membrane"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-8354-7612","authenticated-orcid":false,"given":"Takaki","family":"Aiso","sequence":"first","affiliation":[{"name":"BioProcess Technology Research Laboratories I, Daiichi Sankyo Co. Ltd., 2716\u20101 Kurakake Akaiwa Gunma Japan"},{"name":"Graduate School of Science and Technology Gunma University Kiryu Gunma Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8573-7428","authenticated-orcid":false,"given":"Hiroshi","family":"Muto","sequence":"additional","affiliation":[{"name":"BioProcess Technology Research Laboratories I, Daiichi Sankyo Co. Ltd., 2716\u20101 Kurakake Akaiwa Gunma Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyota","family":"Suzuki","sequence":"additional","affiliation":[{"name":"BioProcess Technology Research Laboratories I, Daiichi Sankyo Co. Ltd., 2716\u20101 Kurakake Akaiwa Gunma Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yumiko","family":"Masuda","sequence":"additional","affiliation":[{"name":"Biologics Production Technology Department Daiichi Sankyo Co. 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