Establishment of a reference material for potency and identity assays of recombinant COVID-19 vaccine active ingredients, intermediary and final products

Introduction: The Immunobiological Technology Institute (Bio-Manguinhos) has been producing the recombinant COVID-19 vaccine (RCV) due to a technology transfer (TT) with AstraZeneca and Oxford University. The RCV is a replication-deficient adenoviral vector vaccine that is offered free of charge to the Brazilian population through the National Immunization Program. Two of the specified tests for quality control release of the vaccine are the potency and the identity determination. To perform these assays, a reference vaccine provided by the transfers is used as a reference material (RM) in order to validate the results. After the TT completion, Bio-Manguinhos had to establish its own RM. Therefore, homogeneity and stability studies were carried out to verify the suitability of RM produced by Bio-Manguinhos.