{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T04:10:36Z","timestamp":1793074236772,"version":"4.5.0"},"reference-count":28,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2022,7,5]],"date-time":"2022-07-05T00:00:00Z","timestamp":1656979200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100010767","name":"Innovative Medicines Initiative (IMI2)","doi-asserted-by":"publisher","award":["115924"],"award-info":[{"award-number":["115924"]}],"id":[{"id":"10.13039\/501100010767","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Sanofi","award":["115924"],"award-info":[{"award-number":["115924"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Vaccines undergo stringent batch-release testing, most often including in-vivo assays for potency. For combination vaccines, such as diphtheria-tetanus-pertussis (DTaP), chemical modification induced by formaldehyde inactivation, as well as adsorption to aluminum-based adjuvants, complicates antigen-specific in-vitro analysis. Here, a mass spectrometric method was developed that allows the identification and quantitation of DTaP antigens in a combination vaccine. Isotopically labeled, antigen-specific internal standard peptides were employed that permitted absolute quantitation of their antigen-derived peptide counterparts and, consequently, the individual antigens. We evaluated the applicability of the method on monovalent non-adjuvanted antigens, on final vaccine lots and on experimental vaccine batches, where certain antigens were omitted from the drug product. Apart from the applicability for final batch release, we demonstrated the suitability of the approach for in-process control monitoring. The peptide quantification method facilitates antigen-specific identification and quantification of combination vaccines in a single assay. This may contribute, as part of the consistency approach, to a reduction in the number of animal tests required for vaccine-batch release.<\/jats:p>","DOI":"10.3390\/vaccines10071078","type":"journal-article","created":{"date-parts":[[2022,7,6]],"date-time":"2022-07-06T21:15:52Z","timestamp":1657142152000},"page":"1078","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Mass Spectrometry-Based Quantification of the Antigens in Aluminum Hydroxide-Adjuvanted Diphtheria-Tetanus-Acellular-Pertussis Combination Vaccines"],"prefix":"10.3390","volume":"10","author":[{"given":"Larissa","family":"van der Maas","sequence":"first","affiliation":[{"name":"Intravacc, Antonie van Leeuwenhoeklaan 9, 3721 MA Bilthoven, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maarten","family":"Danial","sequence":"additional","affiliation":[{"name":"Intravacc, Antonie van Leeuwenhoeklaan 9, 3721 MA Bilthoven, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8884-0685","authenticated-orcid":false,"given":"Gideon F. A.","family":"Kersten","sequence":"additional","affiliation":[{"name":"Intravacc, Antonie van Leeuwenhoeklaan 9, 3721 MA Bilthoven, The Netherlands"},{"name":"Division of BioTherapeutics, Leiden Academic Centre for Drug Research (LACDR), Leiden University, 2333 CC Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6814-7656","authenticated-orcid":false,"given":"Bernard","family":"Metz","sequence":"additional","affiliation":[{"name":"Intravacc, Antonie van Leeuwenhoeklaan 9, 3721 MA Bilthoven, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0455-8899","authenticated-orcid":false,"given":"Hugo D.","family":"Meiring","sequence":"additional","affiliation":[{"name":"Intravacc, Antonie van Leeuwenhoeklaan 9, 3721 MA Bilthoven, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,7,5]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"73","DOI":"10.1016\/j.biologicals.2007.05.002","article-title":"The consistency approach for the quality control of vaccines","volume":"36","author":"Hendriksen","year":"2008","journal-title":"Biologicals"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"59","DOI":"10.1016\/j.biologicals.2010.12.001","article-title":"The consistency approach for quality control of vaccines-a strategy to improve quality control and implement 3Rs","volume":"39","author":"Chapsal","year":"2011","journal-title":"Biologicals"},{"key":"ref_3","unstructured":"European Commission (2019). 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