Hester Biosciences Ltd expects to start supplies of drug substance for Bharat Biotech’s Covid-19 vaccine, Covaxin, by July 2022. The company informed that the recent World Health Organization (WHO) directives suspending Covaxin supplies over GMP compliance concerns will not impact the company’s planned commissioning of the new facility, from where it is slated to supply the active substance for Covaxin.
“This (WHO suspension on Covaxin) is of no concern to us at this point of time. We will continue developing the facility and don’t expect any impact on supplies of drug substance for Covaxin,” Rajiv Gandhi, Managing Director, Hester Biosciences, told BusinessLine.
Earlier this month, the WHO announced suspension of Covaxin’s global supplies through UN procurement agencies after it found deficiencies regarding good manufacturing practices (GMP) at an inspection of Bharat Biotech facility, following which, Bharat Biotech assured corrective measures. Further, WHO ruled out any change in the risk-benefit ratio of the vaccine, and stated that the data available with WHO indicated the vaccine to be “effective and no safety concerns existed”.
Hester Biosciences is developing a Biosafety Level-III (BSL-III) facility to make vaccine substance, which will then be supplied to Bharat Biotech for Covaxin doses. “We have a tie-up with Bharat Biotech who will give us the technology and we will make the drug substance and supply to them. They will make the final product,” said Gandhi.
Commercial rollout soon
The upcoming new facility will be set up at the company's existing plant at Mehsana in North Gujarat. Under the agreement with Bharat Biotech, Hester will supply total 7 million doses-equivalent of finished products. The commercial rollout has been extended by a couple of months due to delay in imports of equipment. "We expect the commercial rollout by June or July," Gandhi told BusinessLine adding that the supplies will happen in a phased-manner.
Also, Hester has developed the facility to suit its future ambitions to foray into human vaccine production. “Our present objective is to produce only the Covid vaccine substance for Covaxin. But, going forward, if Covid incidences drop and the business dynamics change, we need to be prepared for the second plan. We are making a multipurpose BSL-III lab which, in days to come, could be used for other vaccines’ production. This could be our gateway to get into human vaccines,” said Gandhi.
₹130-crore Investment
Hester has also received Grant-in-Aid of ₹60 crore (in phased manner) from Biotechnology Industry Research Assistance Council (BIRAC), Government of India, to support Covid vaccine manufacturing under Mission Covid Suraksha.
"Besides this grant, we will invest additionally ₹70 crore, taking the total investment for the project to ₹130 crore," said Gandhi.
Hester Biosciences, a part of the Gujarat COVID Vaccine Consortium (GCVC) had signed a memorandum of understanding (MoU) with Hyderabad-based vaccine maker Bharat Biotech. Besides Hester, GCVC has Gujarat Biotechnology Research Centre (GBRC) and Omnibrx Biotechnologies as its partners.
Under the agreement signed with GCVC, Bharat Biotech will provide the vaccine substance production technology, while Hester is given the responsibility to provide BSL-III lab for manufacturing, GBRC will provide advisory and mentorship for the technology transfer, while Omnibrx Biotechnologies is the technology support partner in the consortium, which was announced last year.