The Oswaldo Cruz Foundation (Fiocruz) has sent two batches of Pharmaceutical Active Ingredients (IFA) produced at the Institute of Immuno-Biotechnology (Bio-Manguinhos) to the United States.
The batches of raw materials for the production of the AstraZeneca coronavirus vaccine have been approved in internal quality control tests and will now undergo 14 additional tests to ensure they are of the same quality as the imported API.
This was revealed by Fiocruz last Friday (22), adding that the IFA production process goes through strict oversight, which includes 81 tests. Of the 14 scheduled to take place in the US, the longest will last 56 days.
Bio-Manguinhos began national IFA production on July 21, after it received the cell and virus banks stipulated in a technology transfer agreement signed with the Anglo-Swedish pharmaceutical company in early June. In addition to the ready-made pre-validation kits, the institute has already begun production of four more batches, including three qualification batches. “By the end of 2021, Bio-Manguinhos/Fiocruz expects to have, among the API batches produced and processed, the equivalent of more than 30 million doses,” says Fiocruz.
In addition to quality checks, Bio-Manguinhos will begin the process of changing the AstraZeneca vaccine’s registration with the National Health Surveillance Agency (Anvisa) next month. Currently, the vaccine registry reports that IFA for dosing is produced in the Chinese laboratory WuXi Biologics. Anvisa will include Bio-Manguinhos as a manufacturing hub. The change is necessary for Fiocruz to continue providing the vaccine to the National Immunization Program (PNI).
Since March, the Foundation has already delivered 113.8 million doses of the vaccine, produced using imported IFA. Another 16.7 million doses are ready and in various stages of the quality control process. Of those, about 15 million could come out as of next week.
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