Oswaldo Cruz Foundation (Fiocruz)
By means of its Immunobiological Technology Institute (Bio-Manguinhos), last Monday (September 27th) Fiocruz ended the production of the first batches called pre-validation batches of the national Active Pharmaceutical Ingredient (API) for the COVID-19 vaccine. The ingredient will now be submitted to quality control tests at the institution to then be sent to the final processing phase of the vaccine. The first pre-validation batch, which was produced early in September, is also under analysis.
The goal of the two pre-validation batches is to show that the process works as expected and, if that is the case, to detect the need to adapt documents and processes. They were both manufactured under Good Manufacturing Practices (GMP); all the production procedures, protocols and validations have already been approved.
Two other batches, of a second stage for the manufacturing of the national API for the validation of this ingredient produced in Brazil, are under production: one is at the bioreaction phase, when cells are infected by the virus so the virus can multiply, and the other is in the cellular expansion phase, when cells are multiplied in culture media. A third validation batch for the ingredient is also to be produced, according to the regulation requisites to request a registration.
The batches will be sent to AstraZeneca for comparability tests, so as to confirm that the results obtained by Bio-Manguinhos/Fiocruz are in accordance with those preconized by the origin of the technology transfer. After this phase, the documents necessary to alter the place of manufacture of the API in the registration of the vaccine will be sent to the National Agency of Sanitary Surveillance (Anvisa), a requirement for the delivery of the national doses to the National Immunization Program.
Fiocruz works with a conservative scenario for the phases of production, quality control, and registration to supply Covid-19 vaccines made with the national API. Delivery is expected to begin in the last quarter of 2021.