Bharat Biotech may receive Covaxin drug substance from IIL in June

Bharat Biotech, which is in the process of scaling up production capacity for its Covid-19 vaccine Covaxin to one billion doses per annum (pa), is likely to receive the drug substance manufactured by its partner Indian Immunologicals (IIL) by mid-June.

Bharat Biotech will fill-and-finish the drug substance to make the final vaccine formulation. Drug substance manufacturing requires high biosafety level (BSL) environments and involves culturing the viral antigen in large cultures to get the raw material of the vaccine. This is the time-consuming part of vaccine production and vaccine industry veterans say it needs time and precision.

Industry sources confirmed that IIL is likely to produce drug substances to manufacture 10-15 million doses per month. In April, Bharat Biotech had said it has partnered Hyderabad-based IIL to procure drug substance and the technology transfer process was underway. “The technology transfer process is well underway and IIL has the capabilities and expertise to manufacture inactivated viral vaccines at commercial scale and under biosafety containment,” the company had said then.

Drug substance is the raw material needed to make the vaccine formulation and contains the viral antigen. In the case of Bharat Biotech’s vaccine, it is the inactivated Sars-CoV-2 virus (which is prepared in large cultures in BSL-3 labs and then inactivated chemically). Meanwhile, Bharat Biotech is actively ramping up capacities to make Covaxin at its sites. On Thursday, the firm said it will make 200 million doses of Covaxin pa at its rabies vaccine manufacturing facility in Ankleshwar, Gujarat.

The Chiron Behring vaccine manufacturing facility was acquired by Bharat Biotech in 2019 from GlaxoSmithKline(GSK) Asia and is a single-product manufacturing site. This capacity is expected to be available in the October-December quarter of 2021.

Together with Ankleshwar, the company’s Covaxin manufacturing capacity is estimated to touch 900 million doses per annum – 500 million doses per annum from its two sites in Hyderabad Genome Valley and 200 million doses from Kolar facility near Bengaluru.
 

Add to this the drug substance to make 120 million doses of Covaxin per annum from IIL.

The total Covaxin capacity is thus expected to cross one billion doses annually.

This is almost equal to the AstraZeneca vaccine (Covishield) by Serum Institute of India (SII). SII is now making 60 million doses a month of Covishield, and from July, it is expected to make 100 million doses a month of the vaccine, taking its total capacity in 2021 to 960 million doses.

The Union health ministry said recently that it expects 750 million doses of Covishield to be available between August and December. Around 550 million doses of Covaxin will be available during the same period.

Apart from its own facilities, talks are on for potential partnerships to further augment Covaxin production. The Centre has already said that Mumbai-based Haffkine Biopharmaceutical Corporation, IIL and Bharat Immunologicals & Biologicals (BIBCOL) will also partner Bharat Biotech. Of this, Haffkine is expected to make 20 million doses per month and BIBCOL around 10-15 million doses per month. Gujarat-based Hester Biosciences is also likely to partner in capacity ramp-up and a review of its facilities is currently on.

BSL-3 facilities have to be set up at these firms before any tech transfer can happen from Bharat Biotech. IIL could do it faster, as it already has a BSL-2 facility.