Red And White Vaccine Researchers Grateful For Biotis To Receive CPOB Certificate From BPOM

SURABAYA - Researchers from Airlangga University Surabaya are grateful that PT Biotis, the pharmaceutical company responsible for the mass manufacturing process of the Red and White Vaccine, has received a certificate of Good Manufacturing Practice (GMP) from the Food and Drug Administration.

Coordinator of COVID-19 Research Products Universitas Airlangga Prof. Ni Nyoman Tri Puspaningsih in Surabaya, Thursday said the GMP certificate was proof that PT Biotis had gone through and met the assessment standards as a pharmaceutical company that produces COVID-19 vaccines.

"BPOM has given a CPOB certificate, meaning that it has been recognized that PT Biotis will be able to mass produce the Red and White Vaccine whose research is carried out by Unair researchers," he said, quoted by Antara, Thursday, August 19.

Puspaningsih also said that the assessment is an assessment of the feasibility and standardization of production safety, namely the industrial production process must comply with GMP (good manufacturing product).

"So international standards have been met and certificates have been obtained. When the vaccine has finished clinical trials, it will be directly produced by PT Biotis, we as researchers are ready to go," he continued.

With PT Biotis getting this GMP certificate, he said, the vaccine development carried out by Unair researchers is just one step away, namely clinical trials.

Currently, said Puspaningsih, the vaccine development process has gone through the preclinical test stage with macaque animal testing.

The target of this vaskin is almost all groups, namely children over the age of 12 years, men, women, the elderly and pregnant women.

So, continued Puspaningsih, the macaque animal test was also carried out with the same category approach, namely testing on children, old, male, female and pregnant macaques.

"Currently there are 40 macaques with various categories that are in the process of being vaccinated. Some have been injected with the vaccine twice, some are still once. From this process we need to see progress and conduct an analysis," he said.

Preclinical trials on macaques, he said, would at least be completed in October, after which clinical trials could be conducted.