Brazil’s Fiocruz says that production of the active pharmaceutical ingredient (API) for its COVID-19 vaccines is ongoing and is now moving on to a new and important phase of the process.
Two pre-validation batches of the product manufactured by Fiocruz have been approved in all in-house quality tests and are now on their way to an external quality control at US laboratories. At these labs, the samples will go through a complex testing process that involves 14 tests in addition to those carried out in Brazil, the longest of which takes 56 days to complete.
This set of tests compare Brazilian and foreign APIs, ensuring that the product manufactured at the Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz) meets the same quality standards and safety of those acquired by means of Technological Order signed with UK pharma major AstraZeneca (LSE: AZN).
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