Page 24 - Badan POM Serahkan Sertifikat CPOB kepada PT Biotis untuk Dukung Produksi Vaksin Merah Putih

Judul : BPOM Grants GMP Certificate for Merah Putih Vaccine Production

Nama Media : tempo.co

Tanggal : 18 Agustus 2021

Halaman/URL:https://en.tempo.co/read/1496000/bpom-grants-gmp-certificate-for-
merah-putih-vaccine-production

Tipe Media : Online

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.