Capacity expansion in vaccines manufacturing is a long and tedious process, requiring investments of several millions of rupees and several years. 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 preexisting expertise and know-how to manufacture, test and release highly purified inactivated viral vaccines, the company said in a statement.
‘Bharat Biotech has stated that capacity expansion has been implemented across multiple facilities here and in Bengaluru, to reach 700 million COVID doses a year, one of the largest production capacities for inactivated viral vaccines worldwide.’
It said it was also exploring manufacturing partnerships with its partners in other countries, who have prior expertise with commercial scale manufacture of inactivated viral vaccines under biosafety containment.
To further increase capacities, Bharat Biotech has partnered with Indian Immunologicals Ltd (IIL) to manufacture the drug substance for Covaxin. The technology transfer process is underway and IIL has the capabilities and expertise to manufacture inactivated viral vaccines at commercial scale and under biosafety containment.
Covaxin has received Emergency Use Authorisations (EUAs) 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 $15-20/dose.
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 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.
“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,” it added.
Source: IANS
