TY - JOUR
T1 - Zoonoses Anticipation and Preparedness Initiative, stakeholders conference, February 4 & 5, 2021
AU - Beer, Martin
AU - Amery, Leanne
AU - Bosch, Berend-Jan
AU - Brix, Alexander
AU - Daramola, Olalekan
AU - Inman, Sophie
AU - Jungbäck, Carmen
AU - Kortekaas, Jeroen
AU - Lindo, Viv
AU - Okorji-Obike, Uche
AU - Rodriguez-Conde, Sara
AU - Tang, Alison
AU - Tchelet, Ronen
AU - Vandeputte, Joris
AU - Wichgers Schreur, Paul J
AU - Osterhaus, Ab
AU - Haagmans, Bart
AU - Audonnet, Jean-Christophe
N1 - Funding Information:
The Zoonoses Anticipation and Preparedness Initiative project (ZAPI; IMI Grant Agreement n°115760) has been performed with the assistance and financial support of IMI and the European Commission , and in-kind contributions from EFPIA partners.
Publisher Copyright:
© 2021
PY - 2021/11
Y1 - 2021/11
N2 - 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.
AB - 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.
KW - Antibody
KW - Bacterial superglue
KW - Multimeric protein scaffold particles
KW - Platform master file
KW - Surge capacity
KW - Vaccine
UR - http://www.scopus.com/inward/record.url?scp=85119514448&partnerID=8YFLogxK
U2 - 10.1016/j.biologicals.2021.10.003
DO - 10.1016/j.biologicals.2021.10.003
M3 - Article
C2 - 34736782
SN - 1045-1056
VL - 74
SP - 10
EP - 15
JO - Biologicals
JF - Biologicals
ER -