CDMO Jubilant HollisterStier will supply Indian COVID-19 vaccine Covaxin from its sterile injectable site in Spokane, Washington, currently undergoing a capacity expansion.

Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is a highly purified and inactivated vaccine manufactured using a vero cell manufacturing platform.

Philadelphia-based biotech Ocugen is working with Bharat to bring the vaccine in Canada and the US and has selected contract development and manufacturing organization (CDMO) Jubilant HollisterStier to help produce the drug product for the Covaxin ahead of its potential commercialization.

Jubilant Hoister’s facility in Spokane, WA. Image c/o Google

“We are fully committed to bringing Covaxin to the US and Canadian markets because we believe it has the potential to save lives by adding a weapon to the arsenal in the fight against emerging variants,” said J.P. Gabriel, Ocugen’s SVP of Manufacturing and Supply Chain.

“Securing US-based manufacturing capability is a critical step as we prepare to submit our regulatory submissions to the FDA and Health Canada. Based on Bharat Biotech’s strong track record of developing and commercializing vaccines globally and Jubilant’s proven track record in manufacturing, we are well-prepared to transition US manufacturing of Covaxin to our new partner.”

Jubilant HollisterStier has two facilities in North America – one in Montreal, Canada and the other in Spokane, Washington.

The Ocugen deal will be serviced from the Spokane site, which earlier this month was subject to a $92 million sterile injectable expansion by the CDMO, expected to be operational in 2024.

The investment will add a 400 vials-a-minute injectable fill line with isolator technology, increasing the Spokane facility’s capacity by 50%. Two 300 square-foot lyophilizers will also be added.

“With two facilities in North America working to manufacture multiple COVID-19 vaccines and therapies, we remain committed to supporting efforts to eradicate this global pandemic and are prepared for a potential future pandemic response,” said Pramod Yadav, CEO Jubilant Pharma Limited (the CDMO’s parent company).

“This expansion will also help us meet high demand from our global Specialty Pharmaceutical customers, with whom the company has established strong relationships.”