Bharat Biotech enters contract manufacturing deal for COVAXIN drug substance
Hester Biosciences on Thursday said a memorandum of understanding (MoU) has been signed between Hyderabad-based vaccine maker Bharat Biotech and Gujarat COVID-19 Vaccine Consortium (GCVC) for contract manufacturing the drug substance for COVAXIN. "GCVC comprises Gujarat Biotechnology Research Center (GBRC), Hester Biosciences and Omnibrx Biotechnologies Pvt. Ltd.," Hester Biosciences had said in a regulatory filing.
Here are the details of the arrangement
"As per 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. "Hester shall provide infrastructure at its Gujarat plant for manufacturing of the drug substance and Omnibrx shall act as a technology support partner," the filing said.
Estimated cost of the project pegged at Rs. 40 crore
"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," it added. "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.
Important to accelerate vaccine production: Gujarat government
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 that 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.
Contract manufacturing can solve the vaccine crisis
"This is possible by expanding the production of the current vaccine through contract manufacturing," it added. Considering this, GBRC along with Hester and Omni BRx Technologies have formed a consortium and entered into MoU with Bharat Biotech for contract manufacturing of drug substance for COVAXIN.
Vaccine manufacturing facilities need to meet several criteria
The manufacturing of vaccine is a complicated procedure and 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.
GBRC has signed MoU with three companies
"The Gujarat government, at a suitable point of time, will enter into a buyback agreement with Bharat Biotech for required doses of COVAXIN as per the rate and policy of the Government of India," it further said. GBRC had last year signed MoU with three companies - Hester Biosciences, Supratech Laboratory and Vekaria Healthcare LLP - to develop a COVID-19 vaccine and diagnostics.
