BPOM Grants GMP Certificate for Merah Putih Vaccine Production
18 August 2021 19:15 WIB
TEMPO.CO, Jakarta - The Food and Drug Monitoring Agency (BPOM) granted a certificate of Good Manufacturing Practices (GMP) Fill and Finish Facility for the production of homegrown Covid-19 vaccine candidate to PT Biotis Pharmaceuticals.
The vaccine developed by PT Biotis in collaboration with Airlangga University or Unair is part of the Merah Putih vaccine program being prepared by the government.
BPOM head Penny Lukito said her side carried out various assistance ranging from facility design, inspection, desk consultation, inspection, up to repairment, in order to issue the GMP certificate.
“This is not easy,” said Penny in an online press conference after the GMP certificate handover on Wednesday, August 18.
Penny said PT Biotis is the second-largest human vaccine production industry in Indonesia after state-run pharmacy Bio Farma. Of the six vaccine candidates being developed by a number of parties, the Merah Putih vaccine developed by Unair showed the most advanced development.
The first phase pre-clinical trial of the inactivated vaccine on transgenic animals has been completed. At present, the second phase trial on macaques is underway.
“Hopefully, the Merah Putih vaccine produced by Unair and Biotis [can be mass produced] in the first semester of 2022, if it goes according to the plan,” said Penny.