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Regulatory guidelines require manufacturers to monitor process\u2010related impurities along the purification workflow. Mass spectrometry (MS) has recently been considered as a complementary method to the well\u2010established ELISA for HCPs quantification, since it has the advantage of unambiguously identifying individual HCP. In this study, we developed an innovative standard dedicated to MS\u2010based HCP profiling analysis in order to monitor the consistency of viral vaccine intermediate purification samples. This standard, termed the HCP\u2010PROFILER standard, is composed of a water\u2010soluble bead (READYBEADS technology) which, after being added into the sample, releases unlabeled peptides in controlled amounts. The standard meets three desired criteria: (1) it is composed of multiple peptides, at different concentration levels, allowing construction of a calibration curve covering the dynamic range of HCPs present in the target sample, ensuring quantification accuracy; (2) it demonstrates high batch\u2010to\u2010batch reproducibility, ensuring quantification robustness and consistency over time; and (3) it is easy to use and avoids user\u2010induced analytical biases. In this study, we present the use of the HCP\u2010PROFILER standard for vaccine batches comparison and downstream process performance studies.<\/jats:p>","DOI":"10.1002\/pmic.202000152","type":"journal-article","created":{"date-parts":[[2021,1,18]],"date-time":"2021-01-18T08:32:47Z","timestamp":1610958767000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["An innovative standard for LC\u2010MS\u2010based HCP profiling and accurate quantity assessment: Application to batch consistency in viral vaccine samples"],"prefix":"10.1002","volume":"21","author":[{"given":"Mathieu","family":"Trauchessec","sequence":"first","affiliation":[{"name":"ANAQUANT  Villeurbanne France"},{"name":"CEA  17 av. des Martyrs Grenoble 38000 France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne Marie","family":"Hesse","sequence":"additional","affiliation":[{"name":"CEA  17 av. des Martyrs Grenoble 38000 France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Kraut","sequence":"additional","affiliation":[{"name":"CEA  17 av. des Martyrs Grenoble 38000 France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yves","family":"Berard","sequence":"additional","affiliation":[{"name":"SANOFI PASTEUR  Marcy\u2010l\u2019\u00c9toile France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Herment","sequence":"additional","affiliation":[{"name":"ANAQUANT  Villeurbanne France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanguy","family":"Fortin","sequence":"additional","affiliation":[{"name":"ANAQUANT  Villeurbanne France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christophe","family":"Bruley","sequence":"additional","affiliation":[{"name":"CEA  17 av. des Martyrs Grenoble 38000 France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myriam","family":"Ferro","sequence":"additional","affiliation":[{"name":"CEA  17 av. des Martyrs Grenoble 38000 France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1055-0834","authenticated-orcid":false,"given":"Catherine","family":"Manin","sequence":"additional","affiliation":[{"name":"SANOFI PASTEUR  Marcy\u2010l\u2019\u00c9toile France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,2,23]]},"reference":[{"key":"e_1_2_9_2_1","first-page":"52","article-title":"Defining your product profile and maintaining control over it, part 2","volume":"3","author":"Champion K.","year":"2005","journal-title":"Bioprocess International"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-016-9998-7"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/bit.22982"},{"key":"e_1_2_9_5_1","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 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