Development of a multiplex-based immunoassay for the characterization of diphtheria, tetanus and acellular pertussis antigens in human combined DTaP vaccines

Agnolon, 2016, Multiplex immunoassay for in vitro characterization of acellular pertussis antigens in combination vaccines, Vaccine, 34, 1040, 10.1016/j.vaccine.2016.01.012 Akkermans, 2020, Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities, Biologicals, 68, 92, 10.1016/j.biologicals.2020.07.010 Aly, 2018, Assessment of in vitro potency of inactivated Newcastle disease oil adjuvanted vaccines using hemagglutination test and blocking ELISA, Vet. World, 11, 1222, 10.14202/vetworld.2018.1222-1228 Angeloni, S., Shubhagata, D., Dunbar, S., Stone, V. & Swift, S. Luminex xMAP® Cookbook. vol. 4. Bogahawaththa, 2019, Thermal denaturation of bovine β-lactoglobulin in different protein mixtures in relation to antigenicity, Int. Dairy J., 91, 89, 10.1016/j.idairyj.2018.10.004 Brito, 2013, Vaccine adjuvant formulations: a pharmaceutical perspective, Semin. Immunol., 25, 130, 10.1016/j.smim.2013.05.007 Bruysters, 2017, Drivers and barriers in the consistency approach for vaccine batch release testing: report of an international workshop, Biologicals, 48, 1, 10.1016/j.biologicals.2017.06.006 Chabaud-Riou, 2017, G-protein based ELISA as a potency test for rabies vaccines, Biologicals, 46, 124, 10.1016/j.biologicals.2017.02.002 Costa, 2011, Establishment and validation of an ELISA for the quantitation of HBsAg in recombinant hepatitis B vaccines, J. Virol. Methods, 172, 32, 10.1016/j.jviromet.2010.12.010 Davis, 1998, Protein modification by thermal processing, Allergy, 53, 102, 10.1111/j.1398-9995.1998.tb04975.x De Mattia, 2011, The consistency approach for quality control of vaccines – a strategy to improve quality control and implement 3Rs, Biologicals, 39, 59, 10.1016/j.biologicals.2010.12.001 Descamps, 2011, A case study of development, validation, and acceptance of a non-animal method for assessing human vaccine potency, Procedia Vaccinol., 5, 184, 10.1016/j.provac.2011.10.018 Dey, 2014, Physicochemical and functional characterization of vaccine antigens and adjuvants, Expert Rev. Vaccines, 13, 671, 10.1586/14760584.2014.907528 Dierick, 2022, The consistency approach for the substitution of in vivo testing for the quality control of established vaccines: practical considerations and progressive vision, Open Res. Eur., 2, 116, 10.12688/openreseurope.15077.2 European Medicines Agency European Parliament AND Council of the European Union, 2010 European Phamacopoeia. General chapter 5.2.14. Substitution of in vivo methods by in vitro methods for the quality control of vaccines. Eur. Pharmacop. 10. Francotte, A. et al. Characterization of a panel of monoclonal antibodies directed against the acellular pertussis antigens, a first step towards an alternative for in vivo potency assays. Biologicals Submitted. van Gageldonk, 2008, Development and validation of a multiplex immunoassay for the simultaneous determination of serum antibodies to Bordetella pertussis, diphtheria and tetanus, J. Immunol. Methods, 335, 79, 10.1016/j.jim.2008.02.018 Hubbard, 2018, Vapor phase hydrogen peroxide decontamination or sanitization of an isolator for aseptic filling of monoclonal antibody drug product—hydrogen peroxide uptake and impact on protein quality, PDA J. Pharm. Sci. Technol., 72, 348, 10.5731/pdajpst.2017.008326 Hutcheon, 2006, Physiochemical and functional characterization of antigen proteins eluted from aluminum hydroxide adjuvant, Vaccine, 24, 7214, 10.1016/j.vaccine.2006.06.043 Ibsen, 1996, The effect of formaldehyde, hydrogen peroxide and genetic detoxification of pertussis toxin on epitope recognition by murine monoclonal antibodies, Vaccine, 14, 359, 10.1016/0264-410X(95)00230-X Kalies, 2006, The use of combination vaccines has improved timeliness of vaccination in children, Pediatr. Infect. Dis. J., 25, 507, 10.1097/01.inf.0000222413.47344.23 Kishore, 2012, Thermal, chemical and pH induced denaturation of a multimeric β-galactosidase reveals multiple unfolding pathways, PLoS One, 7, 10.1371/journal.pone.0050380 Kushwah, 2020, Towards an understanding of the adsorption of vaporized hydrogen peroxide (VHP) residues on glass vials after a VHP decontamination process using a miniaturized tool, J. Pharm. Sci., 109, 2454, 10.1016/j.xphs.2020.04.012 Liu, 2005, Multiplexed analysis of biomarkers related to obesity and the metabolic syndrome in human plasma, using the Luminex-100 system, Clin. Chem., 51, 1102, 10.1373/clinchem.2004.047084 Maas, 2000, Antigen quantification as in-vitro alternative for potency testing of inactivated viral poultry vaccines, Vet. Q., 22, 223, 10.1080/01652176.2000.9695063 Marshall, 2007, Use of combination vaccines is associated with improved coverage rates, Pediatr. Infect. Dis. J., 26, 496, 10.1097/INF.0b013e31805d7f17 Riches-Duit, 2019, Evaluation of a capture antigen ELISA for the characterisation of tetanus vaccines for veterinary use, Biologicals, 61, 8, 10.1016/j.biologicals.2019.08.003 Riches-Duit, 2021, Characterisation of diphtheria monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay, Biologicals, 69, 38, 10.1016/j.biologicals.2020.12.002 Riches-Duit, 2021, Characterisation of tetanus monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay, Biologicals, 71, 31, 10.1016/j.biologicals.2021.04.002 Seeber, 1991, Solubilization of aluminum-containing adjuvants by constituents of interstitial fluid, J. Parenter. Sci. Technol. Publ. Parenter. Drug Assoc., 45, 156 Shanmugham, 2010, Immunocapture enzyme-linked immunosorbent assay for assessment of in-vitro potency of recombinant hepatitis B vaccines, Clin. Vaccine Immunol., 17, 1252, 10.1128/CVI.00192-10 Sigoillot-Claude, 2015, A versatile in vitro ELISA test for quantification and quality testing of infectious, inactivated and formulated rabies virus used in veterinary monovalent or combination vaccine, Vaccine, 33, 3843, 10.1016/j.vaccine.2015.06.091 Skibinski, 2011, Combination vaccines, J. Global Infect. Dis., 3, 63, 10.4103/0974-777X.77298 Stalpers, 2021, Variability of in vivo potency tests of diphtheria, tetanus and acellular pertussis (DTaP) vaccines, Vaccine, 39, 2506, 10.1016/j.vaccine.2021.03.078 Stalpers, 2022, Corrigendum to “Variability of in vivo potency tests of Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccines” [Vaccine 39(18) (2021) 2506–2516], Vaccine, 40, 3272, 10.1016/j.vaccine.2022.04.047 Suresh, 2018, Quality control of vaccines-a journey from classical approach to 3Rs, Microbiol. Curr. Res., 02 Ugozzoli, 2011, Flow cytometry: an alternative method for direct quantification of antigens adsorbed to aluminum hydroxide adjuvant, Anal. Biochem., 418, 224, 10.1016/j.ab.2011.07.012 United States Pharmacopoeia, 2010 VAC2VAC Wang, 2018, Development of a relative potency test using ELISA for human rabies vaccines, Biologicals, 55, 59, 10.1016/j.biologicals.2018.06.003 Weißer, 1997 World Health Organization, 2013, 300 Yurkovetsky, 2010, Development of a multimarker assay for early detection of ovarian Cancer, J. Clin. Oncol., 28, 2159, 10.1200/JCO.2008.19.2484 Zhu, 2009, Development of a direct Alhydrogel formulation immunoassay (DAFIA), J. Immunol. Methods, 344, 73, 10.1016/j.jim.2009.03.005