The Pharmaceutical Technology Institute (Farmanguinhos/Fiocruz) announced that it has completed yet another stage in the transfer of technology for an antiretroviral used in pre-exposure HIV prophylaxis (PrEP). This transfer process is intended to enable the institute to master the stages of drug development and marketing.
The antiretroviral is a tablet made up of Emtricitabine+Tenofovir. Like the other drugs used in PrEP, if used daily, it acts as a chemical barrier against the virus, preventing HIV contamination. Those who do this type of prophylaxis, however, should not stop using condoms.
The institution performs the technology transfer in reverse order, that is, it starts with the final phases (quality control and packaging), proceeds to validation with Anvisa (National Health Surveillance Agency) and, subsequently, continues to internalize the other stages of drug production.
The stage now completed by the institute is the primary packaging of the drug. About 75 thousand units can already be sent to the Ministry of Health. The next phase, which will be carried out in 2022, consists of absorbing the manufacturing process of the pills. From then on, the entire production of the antiretroviral will take place at the Drug Technological Complex (CTM) in Farmanguinhos.
“This is a big and important step for the project to fully internalize the production in Farmanguinhos, as it involves a lot of validation work, monitoring the quality of the pills”, says Abel Alves, responsible for the Management Assistance area for Absorption and Transfer Projects Institute of Technology.
The national industry Blanver, a partner of Farmanguinhos/Fiocruz, accompanied the packaging stage. Now, the unit must forward the request for the production of primary packaging to Anvisa.
Reference: CNN Brasil
