Propagation of SARS-CoV-2 in a Closed Cell Culture Device: Potential GMP Compatible Production Platform for Live-Attenuated Vaccine Candidates under BSL-3 Conditions?

Klessing S, Peter AS, Fraedrich K, Wagner J, Kummer M, Deutschmann J, Steininger P, Steibl HD, Überla K (2023)

Publication Type: Journal article

Publication year: 2023

Journal

Viruses MDPI

Book Volume: 15

Journal Issue: 2

DOI: 10.3390/v15020397

Abstract

Live-attenuated SARS-CoV-2 vaccines present themselves as a promising approach for the induction of broad mucosal immunity. However, for initial safety assessment in clinical trials, virus production requires conditions meeting Good Manufacturing Practice (GMP) standards while maintaining biosafety level 3 (BSL-3) requirements. Since facilities providing the necessary complex ventilation systems to meet both requirements are rare, we here describe a possibility to reproducibly propagate SARS-CoV-2 in the automated, closed cell culture device CliniMACS Prodigy® in a common BSL-3 laboratory. In this proof-of-concept study, we observed an approximately 300-fold amplification of SARS-CoV-2 under serum-free conditions with high lot-to-lot consistency in the infectious titers obtained. With the possibility to increase production capacity to up to 3000 doses per run, this study outlines a potential fast-track approach for the production of live-attenuated vaccine candidates based on highly pathogenic viruses under GMP-like conditions that may contribute to pandemic preparedness.

Authors with CRIS profile

Antonia Sophia Peter Institute of Clinical and Molecular Virology Jannik Wagner Institute of Clinical and Molecular Virology Janina Deutschmann Institute of Clinical and Molecular Virology Philipp Steininger Institute of Clinical and Molecular Virology Klaus Überla Lehrstuhl für Klinische und Molekulare Virologie

Involved external institutions

Miltenyi Biotec GmbH

Germany (DE)

How to cite

APA:

Klessing, S., Peter, A.S., Fraedrich, K., Wagner, J., Kummer, M., Deutschmann, J.,... Überla, K. (2023). Propagation of SARS-CoV-2 in a Closed Cell Culture Device: Potential GMP Compatible Production Platform for Live-Attenuated Vaccine Candidates under BSL-3 Conditions? Viruses, 15(2). https://doi.org/10.3390/v15020397

MLA:

Klessing, Stephan, et al. "Propagation of SARS-CoV-2 in a Closed Cell Culture Device: Potential GMP Compatible Production Platform for Live-Attenuated Vaccine Candidates under BSL-3 Conditions?" Viruses 15.2 (2023).

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