Fiocruz: Brazil API to undergo 14 tests in US

The longest of all tests is said to last 56 days

Published in 25/10/2021 - 14:26 By Vinícius Lisboa - Rio de Janeiro

The Oswaldo Cruz Foundation (Fiocruz) has sent to the US two pre-validation batches of the active pharmaceutical ingredient (API) produced by the Immuno-biological Technology Institute Bio-Manguinhos.

The raw material for the production of the AstraZeneca vaccine against COVID-19 have been approved by internal quality control and will now undergo another 14 tests to ensure they meet the same quality parameters of the imported API.

Fiocruz made the statement last Friday (Oct. 22) and explained that the process of producing the API is strictly controlled, encompassing 81 tests in all. Of the 14 that will be carried out in the US, the longest is said to last 56 days.

Bio-Manguinhos started producing Brazil’s API on July 21, after it received in early June the cell and virus banks as laid out in the technology transfer deal with the Anglo-Swiss firm. In addition to the pre-validation batches, already prepared, the institute has started the manufacture of another four batches, including three for qualification. “By the end of 2021, Bio-Manguinhos/Fiocruz should have, the equivalent of over 30 million doses—including API batches both produced and in process,” Fiocruz stated.

In addition to quality tests, Bio-Manguinhos next month will start the process of altering the AstraZeneca vaccine registration at Brazil’s national sanitary regulator Anvisa. As per the current vaccine registration, the API is produced at Chinese laboratory WuXi Biologics. Anvisa should thus include Bio-Manguinhos as place of manufacture. The change is expected to ensure that Fiocruz to continue providing vaccines under the country’s National Immunization Program (PNI).

Since March, the foundation has delivered 113.8 million doses of the vaccine, produced with imported API. More than 16.7 million doses are ready and are in a number of different stages of quality control. Of those, some 15 million may be ready next week.

Translation: Fabrício Ferreira -  Edition: Valéria Aguiar / Nira Foster

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