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Consequently, comprehensive and systematic characterization of leachables clearance during UF\/DF is required and essential.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>To achieve this,  the reduction capacity for 28 selected organic compounds spiked into 3 different proteins during UF\/DF processes was investigated\u00a0using liquid chromatography high-resolution mass spectrometry. Selection\u00a0of compounds was based on their presence in representative biomanufacturing processes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Most compounds (24) showed clearance over 98% across the process for the 3 protein materials. The specific protein characteristics and process parameters for each protein had a minimal impact on clearance, with sieving coefficients essentially the same for each\u00a0one of the 3 protein processes. The sieving coefficient is a parameter that characterizes clearance of compounds during UF\/DF. Physicochemical properties of the compounds under study significantly influenced their clearance, with the octanol\u2013water coefficient (Log P)\u00a0being the most crucial factor. Compounds with Log P\u2009&lt;\u20094 had sieving coefficients close to ideal clearance, and compounds with Log P\u2009&gt;\u20097 showed lower but still significant clearance (&gt;\u200993%). Other important parameters were established to be molecular weight, polarizability\u00a0and solvent accessible surface area. Modelling tools based on Orthogonal Partial Least Squares (OPLS) regression were created to predict sieving coefficients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The present work has created a strong background to describe the ability of UF\/DF to remove potential organic leachables. Application of these modelling approaches becomes critical to support product safety assessments. Demonstration of significant removal along UF\/DF operations confirms risk reduction of leachables coming mostly from upstream stages.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Graphical Abstract<\/jats:title>\n                  <\/jats:sec>","DOI":"10.1007\/s11095-026-04050-2","type":"journal-article","created":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T23:00:42Z","timestamp":1774393242000},"page":"1271-1289","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Investigation into Clearance of Organic Compounds from Biomanufacturing Process Streams during Ultrafiltration\/Diafiltration"],"prefix":"10.1007","volume":"43","author":[{"given":"Noem\u00ed","family":"Dorival-Garc\u00eda","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Mulligan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronan","family":"Hayes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Felice","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aidan","family":"Sexton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ping-Ping","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8978-2592","authenticated-orcid":false,"given":"Jonathan","family":"Bones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,3,24]]},"reference":[{"key":"4050_CR1","doi-asserted-by":"publisher","first-page":"98","DOI":"10.1016\/j.fbp.2013.12.002","volume":"93","author":"A Lopes","year":"2015","unstructured":"Lopes A. 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Aidan Sexton, Ronan Hayes, Charles Felice and Ping-Ping Wang are employees of Johnson & Johnson Innovative Medicine. Noem\u00ed Dorival-Garc\u00eda and Anna Mulligan have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}