Hyd based Bharat Biotech to produce 700 million doses of Covaxin annually

Manufacturing scale-up has been carried out in a stepwise manner across multiple facilities at Hyderabad and Bangalore, the company said. Inactivated vaccines, while highly safe, are extremely complex and expensive to manufacture, resulting in lower yields when compared to live virus vaccines.

While capacity expansion in vaccines manufacturing is a long and tedious process, requiring investments of several millions of rupees and several years, Bharat Biotech said it was able to expand Covaxin-manufacturing capacity in a short time mainly due to the availability of new specially-designed BSL- 3 facilities and preexisting expertise and know-how to test and release highly purified inactivated viral vaccines.

"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 on Tuesday.

To further increase capacities, the company 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 that 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 indigenized and will be manufactured at commercial scale within the country. This is the first instance where a novel adjuvant has been commercialized in India.

"The protocols for manufacturing, testing, and release of inactivated vaccines have been tried, tested and validated across several of our vaccines, these also meet the requirements of WHO, Indian and other regulatory authorities. These protocols have delivered consistent results over a 15-year period with more than 300 million doses supplied globally, with excellent safety and performance record," the Hyderabad-based from said.

Covaxin has received emergency use authorizations (EUA) in several countries across the globe with another 60 in the process of doing the same. EUA's have now been obtained from Mexico, Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe, among several other countries. EUA's are in process in the USA and several European countries.