Indian Immunologicals Ltd (IIL) is expected to start production of the Covaxin antigen from June, which it will supply to Bharat Biotech International Ltd for processing into a formulation and packaging, said two people aware of the issue.
“The company has already set up its BSL3 installation (biosafety level 3). It was just a small upgrade to its existing BSL2 + installation. Technology transfer had taken place and small-scale product testing has been completed. Now production will start from the second week of June, ”said one of the two people, seeking anonymity, adding that batches of the drug substance will be sent to Bharat Biotech in July.
Bharat Biotech’s Covaxin is an inactivated vaccine, consisting of two main components: a drug called antigen, which is a virus that has been grown in large quantities at a BSL3 manufacturing facility and then killed with a chemical and of an adjuvant that is a chemical. used to stimulate the immune response of the antigen.
However, despite production starting in mid-June, it would take about two more months for the vaccine to be ready, as growing the virus requires a long gestation period, the other person said.
“Even after the drug is produced and sent to Bharat Biotech, there will be processing, adjuvant addition and a number of other processes that must take place before the vaccine is ready. In addition, once filling is complete, it should be sent to the CDL (Central Drugs Laboratory) in Kasauli to be tested before release. The whole process takes about three months, ”said the second person, seeking anonymity.
Indian Immunologicals is expected to produce a drug substance for about 10 to 15 million doses per month, according to the government. Questions sent to a spokesperson for Bharat Biotech were unanswered at the time of publication, while Indian Immunologicals chief executive K. Anand Kumar declined to comment.
Bharat Biotech announced in April it was partnering with Indian Immunologicals – a vaccine maker owned by the National Dairy Development Board – to manufacture the drug substance for Covaxin. The developer of Covaxin then said that the technology transfer process was underway and that its partner “has the capacity and expertise to manufacture inactivated viral vaccines on a commercial scale and under biosafety containment”.
As Covaxin involves the cultivation of highly infectious SARS-COV-2 in large batches, a BSL3 installation is considered necessary, which has posed many challenges in increasing the capacity of the locally developed vaccine.
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