Indian Immunologicals to produce Covaxin drug substance for Bharat

Amid a shortage of vaccines in India, Hyderabad-based public sector undertaking, Indian Immunologicals Limited (IIL) has produced a drug substance to boost the production of Bharat Biotech's vaccine Covaxin.

The development is expected to pave the way for augmenting the indigenous COVID-19 vaccine production. In April this year, the Indian government had asked IIL and Bharat Biotech to team up to ensure adequate supplies of Covaxin.

IIL has been sanctioned a grant of $8.07 million towards enhancing production capabilities. IIL is also working on another COVID-19 vaccine with animal trials underway.

In a short period of time, IIL performed several activities including the signing of four agreements with Bharat Biotech, even as it repurposed its manufacturing facility in Hyderabad. The company said several activities were done at breakneck speed and production commenced in July.

Better than expected yields

The batches produced at IIL’s manufacturing facility were rigorously tested at Bharat Biotech and met the required quality specifications for the drug substance. "The yields are more than expected," IIL said in a statement.

Dr K Anand Kumar, managing director, IIL, handed over the first lot of the Covaxin Drug Substance to Dr Krishna Ella, chairman and managing director, Bharat Biotech.

Stating that IIL is expected to produce the drug substance for about 10 to 15 million doses per month, Dr Kumar said it will be initially for two to three million doses and will be scaled up to six to seven million per month later in the year.

IIL is in the process of converting its Karakapatla manufacturing unit near Hyderabad into a Bio Safety Level -3 (BSL3) facility for the production of the drug substance, and is also taking up construction of another block. This is as part of the Indian government’s plan to augment the vaccine production in the country and support some public sector companies with grants under 'Mission Covid Suraksha'.