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.

Keywords

Subject

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Not displayed online.

Please leave your comment to this article below.

Mathematical equations can be typed in either LaTeX formats \\[ ... \\] or $$ ... $$, or MathML format <math> ... </math>. Try the LaTeX or MathML example.

Type equation:

Preview:

Copy equation into message below

Close menu

Please click a symbol to insert it into the message box below:

Please enter the link here:

Optionally, you can enter text that should appear as linked text:

Copy link into message below

Please enter or paste the URL to the image here (please only use links to jpg/jpeg, png and gif images):

Copy image into message below

Type author name or keywords to filter the list of references in this group (you can add a new citation under Bibliography):

No existing citations in Discussion Group

Wikify editor is a simple editor for wiki-style mark-up. It was written by MDPI for Sciforum in 2014. The rendering of the mark-up is based on Wiky.php with some tweaks. Rendering of mathematical equations is done with MathJax. Please send us a message for support or for reporting bugs.

Please declare any conflicts of interest you may have with this paper, financial or otherwise.

I do not have a conflict of interest

I would like to declare a conflict of interest

Display my name on the website

Captcha

Renew

I accept the following conditions:

Comments must follow the standards of professional discourse and should focus on the scientific content of the article. Insulting or offensive language, personal attacks and off-topic remarks will not be permitted. Comments must be written in English. Preprints reserves the right to remove comments without notice. Readers who post comments are obliged to declare any competing interests, financial or otherwise.

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

Abstract

Keywords

Subject

Comments (0)