Potency Testing of Whole-Cell Pertussis Containing Vaccines: Lesson Learned in a Multi-Laboratory Assessment of the Pertussis Serological Potency Test

Christina Von Hunolstein; Tim Schofield; Arjen Sloots; Sunil Gairola; Irma Riyanti; Pavlinka Stoyanova; Coenraad Hendriksen; Erti Resnawati; Sivashen Cunden; Pradip Das; Muhammad Erdiansyah; Viktoriya Milanova; Pavel Mitrenga; Saveta Mladenova; Supaporn Phumiamorn; Maya Ramdas; Sreenivasulu Reddy BasiReddy; Sonia Pagliusi; Valentina Salvati; Suchita Sharma; Yojana Shinde; Gurbaksh Singh; Dionne Williams-David; Marcel Thalen; Laura Viviani

doi:10.20944/preprints202311.0333.v1

How to cite: Von Hunolstein, C.; Schofield, T.; Sloots, A.; Gairola, S.; Riyanti, I.; Stoyanova, P.; Hendriksen, C.; Resnawati, E.; Cunden, S.; Das, P.; Erdiansyah, M.; Milanova, V.; Mitrenga, P.; Mladenova, S.; Phumiamorn, S.; Ramdas, M.; BasiReddy, S. R.; Pagliusi, S.; Salvati, V.; Sharma, S.; Shinde, Y.; Singh, G.; Williams-David, D.; Thalen, M.; Viviani, L. Potency Testing of Whole-Cell Pertussis Containing Vaccines: Lesson Learned in a Multi-Laboratory Assessment of the Pertussis Serological Potency Test. Preprints 2023, 2023110333. https://doi.org/10.20944/preprints202311.0333.v1 Von Hunolstein, C.; Schofield, T.; Sloots, A.; Gairola, S.; Riyanti, I.; Stoyanova, P.; Hendriksen, C.; Resnawati, E.; Cunden, S.; Das, P.; Erdiansyah, M.; Milanova, V.; Mitrenga, P.; Mladenova, S.; Phumiamorn, S.; Ramdas, M.; BasiReddy, S. R.; Pagliusi, S.; Salvati, V.; Sharma, S.; Shinde, Y.; Singh, G.; Williams-David, D.; Thalen, M.; Viviani, L. Potency Testing of Whole-Cell Pertussis Containing Vaccines: Lesson Learned in a Multi-Laboratory Assessment of the Pertussis Serological Potency Test. Preprints 2023, 2023110333. https://doi.org/10.20944/preprints202311.0333.v1

Abstract

The Developing Countries Vaccine Manufacturing Network coordinated a multi-laboratory study funded by the US National Institute for Innovation in Manufacturing Biopharmaceuticals to assess the performance of the Pertussis Serological Potency Test (PSPT) in the laboratories of seven whole-cell pertussis vaccine (wP) manufacturers and three National Control Laboratories based in Southeast Asian countries. To this end, common protocols for the immunization of mice and serological testing by ELISA were shared with all laboratories. Each laboratory used their own wP vaccines and the reference vaccine routinely used in the regulatory required mouse protection test (MPT) and assayed the products both in the MPT and PSPT. Whereas in all laboratories the PSPT showed decreased serum IgG levels after immunization with sub-potent compared to potent final batches, some issues were encountered during execution of the assay, which prevented drawing of definitive conclusions on assay performance. Nevertheless, the study provided the participants with the opportunity to familiarize themselves with the PSPT protocols and revealed the next steps to be addressed for implementation of the method.

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Potency Testing of Whole-Cell Pertussis Containing Vaccines: Lesson Learned in a Multi-Laboratory Assessment of the Pertussis Serological Potency Test

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