Bharat Biotech, GCVC sign MoU to produce drug substance for Covaxin
Bharat Biotech shall provide the technology for the production of the drug substance for Covaxin and GBRC will act as an advisor and mentor and will facilitate the technology transfer from Bharat Biotech
28th May, 2021, Mumbai
Hester Biosciences on 27th May 2021 said a memorandum of understanding (MoU) has been signed between vaccine maker Bharat Biotech and Gujarat Covid Vaccine Consortium (GCVC) for contract manufacturing the drug substance for Covaxin.
GCVC comprises Gujarat Biotechnology Research Centre (GBRC), Hester Biosciences and Omnibrx Biotechnologies Pvt Ltd, Hester Biosciences said in a regulatory filing.
As per the MoU, Bharat Biotech shall provide the technology for the production of the drug substance for Covaxin and GBRC will act as an advisor and mentor and will facilitate the technology transfer from Bharat Biotech, it added.
As per filing, Hester shall provide the complete infrastructure at its Gujarat plant for the manufacturing of the drug substance and Omnibrx shall act as a technology support partner.
If everything goes as per the schedule, the drug substance would be available from August 2021 which will be supplied back to Bharat Biotech for producing Covaxin
Hester has estimated an outlay of Rs 40 crore for this project, the company said.
The entire process is facilitated by the Department of Biotechnology, it added.
Shares of Hester Biosciences closed at Rs 2,717.55 per scrip on BSE, up 7.35 percent from the previous close.
Separately, the Gujarat government in a release said in the current situation of COVID-19, it is required to accelerate the production of vaccines which can be made available to the people of Gujarat and India.
This is possible by expanding the production of current vaccine through contract manufacturing, it added.
Considering this, Gujarat Biotechnology Research Centre (GBRC), an autonomous society established under Department of Science and Technology, Government of Gujarat, along with Hester Bioscience Ltd (HBL) and Omni BRx Technologies have formed a consortium (GCVC) and entered into the MoU with Bharat Biotech for contract manufacturing of drug substance for Covaxin.
The manufacturing of vaccine is a highly regulated it requires building BSL3 GMP facility, that is Biosafety Level 3 and bio containment facilities.
According to CDC and WHO guidelines, Biosafety Level 3 is applicable to laboratories where work with indigenous or exotic agents may cause serious disease because of exposure by inhalation route, it said.
However, if everything goes as per the plan, then bulk production of this drug substance equivalent to 20 million doses per month will begin from August 2021.
This will be then supplied back to Bharat Biotech for producing vaccine doses, it noted.
GBRC and Government of Gujarat are acting as mentor, advisor and facilitator for the technology transfer from Bharat Biotech.
HBL will build the BSL3 facility suitable for manufacturing drug substance for Covaxin and shall obtain necessary regulatory approvals, whereas Omni BRx will act as technology support partner, it further said.
HBL CEO and Managing Director Rajiv Gandhi said this entire process is facilitated by the Department of Biotechnology, Government of India.