Determining identity, purity and activity of Benzonase® endonuclease applied on the Recombinant Covid-19 Vaccine active pharmaceutical ingredient production

Abstract

gel was able to detect the presence of putative contaminant proteins in amounts as low as 0.6 μg. The enzymatic activity by UV-Visible method proved to be precise and robust for variations in the incubation time on ice and wavelength of reading. The validation of ICP-OES method for the elemental impurities complied with selectivity acceptance criteria and showed an acceptable sensibility degree. Conclusion: Our results providing sufficient evidences to demonstrate that all assays are suitable for its intended purpose. This multidisciplinary work is now part of the routine of analysis required before Benzonase® utilization in the production of the Recombinant Covid-19 Vaccine API by Bio-Manguinhos/Fiocruz.