The Hyderabad-based manufacturer uses a proprietary adjuvant Algel-IMDG, which has now proven to be a safe and effective adjuvant, especially to stimulate memory T cell responses.
Bharat Biotech on Tuesday said it has scaled up its COVID-19 vaccine Covaxin manufacturing capacity to 700 million doses per annum.
According to a press release issued by the Hyderabad-based vaccine maker, manufacturing scale up has been carried out in a stepwise manner across multiple facilities at Hyderabad and Bangalore.
Sources said the company had 200 million doses capacity when it started producing Covaxin in the beginning.
Capacity expansion in vaccines manufacturing is a long and tedious process, requiring investments and several years, the release said.
"Bharat Biotech is able to expand Covaxin manufacturing capacity in a short timeline, mainly due to the availability of new specially designed BSL-3 facilities, first of its kind for manufacturing in India that have been repurposed and pre-existing expertise and know how to manufacture, test and release highly purified inactivated viral vaccines," the firm said.
Manufacturing partnerships are being explored with our partners in other countries, who have prior expertise with commercial scale manufacture of inactivated viral vaccines under biosafety containment, Bharat Biotech said.
To further increase capacities, Bharat Biotech has partnered with Indian Immunologicals (IIL) to manufacture the drug substance for Covaxin.
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.
Bharat Biotech uses a proprietary adjuvant Algel-IMDG, which has now proven to be a safe and effective adjuvant, especially to stimulate memory T cell responses.
The synthesis and manufacture of the IMDG component has been successfully indigenised and will be manufactured at commercial scale within the country.
This is the first instance where a novel adjuvant has been commercialised in India.
Covaxin has received Emergency Use Authorisations in several countries across the globe with another 60 in process.
EUAs have now been obtained from Mexico, the Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe, among several other countries.
EUAs are in process in the USA and several European countries.
Pricing for international markets and supplies to governments under EUAs have been established between USD15 -20/ dose, the vaccine maker said.