Zoonoses Anticipation and Preparedness Initiative, stakeholders conference, February 4 & 5, 2021

Martin Beer, Leanne Amery, Berend Jan Bosch, Alexander Brix, Olalekan Daramola, Sophie Inman, Carmen Jungbäck, Jeroen Kortekaas, Viv Lindo, Uche Okorji-Obike, Sara Rodriguez-Conde, Alison Tang, Ronen Tchelet, Joris Vandeputte*, Paul J. Wichgers Schreur, Ab Osterhaus, Bart Haagmans, Jean Christophe Audonnet

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

The Zoonoses Anticipation and Preparedness Initiative (ZAPI) was set up to prepare for future outbreaks and to develop and implement new technologies to accelerate development and manufacturing of vaccines and monoclonal antibodies. To be able to achieve surge capacity, an easy deployment and production at multiple sites is needed. This requires a straightforward manufacturing system with a limited number of steps in upstream and downstream processes, a minimum number of in vitro Quality Control assays, and robust and consistent platforms. Three viruses were selected as prototypes: Middle East Respiratory Syndrome (MERS) coronavirus, Rift Valley fever virus, and Schmallenberg virus. Selected antibodies against the viral surface antigens were manufactured by transient gene expression in Chinese Hamster Ovary (CHO) cells, scaling up to 200 L. For vaccine production, viral antigens were fused to multimeric protein scaffold particles using the SpyCatcher/SpyTag system. In vivo models demonstrated the efficacy of both antibodies and vaccines. The final step in speeding up vaccine (and antibody) development is the regulatory appraisal of new platform technologies. Towards this end, within ZAPI, a Platform Master File (PfMF) was developed, as part of a licensing dossier, to facilitate and accelerate the scientific assessment by avoiding repeated discussion of already accepted platforms. The veterinary PfMF was accepted, whereas the human PfMF is currently under review by the European Medicines Agency, aiming for publication of the guideline by January 2022.

Original languageEnglish
Pages (from-to)10-15
Number of pages6
JournalBiologicals
Volume74
DOIs
Publication statusPublished - Nov 2021

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