Univercells Introduces Vaccine Manufacturing Platform

Univercells announced the commercial launch of its proprietary NevoLine bioproduction system for vaccines. The system was initially developed as part of a $12 million Grand Challenges grant awarded by the Bill & Melinda Gates Foundation to deliver affordable inactivated polio vaccine(sIPV).Leading the consortium, Univercells was responsible for the NevoLine system, Batavia Biosciencesfor the polio manufacturing process and Merckfor the purification membrane. After attaining its goals of delivering a very low Cost of Goods for an sIPV below $0.30per trivalent dose, the consortium has now received a $4M grant extension to scale-up the manufacturing system and process in preparation for clinical and commercial application. The first NevoLine system will be installed in Batavia Biosciences’ polio dedicated Biosafety level 3Facility in Leiden, the Netherlands. Based on a novel process architecture, Univercells designed the automated NevoLine bioproduction system that facilitates safer, faster and closed bioprocessing in a much smaller footprint. Through intensification and chaining of unit steps into a continuous process, users achieve high yields with less time and money invested. The sIPV production process using the NevoLine system is capable of producing trivalent sIPV atless than$0.30/dose, representing a five-fold reduction compared to current manufacturing technologies.

"This challenging two-year project aimed at delivering a new manufacturing systemto drastically decrease cost, footprint and time to market for vaccine manufacturers, and we are pleased to have met these goals," Hugues Bultot, CEO and co-founder of Univercells said."The NevoLine system is self-contained into a 6m² series of isolators. A facility designed with four NevoLine units would deliver up to 50 million sIPV doses per year for an estimated capital cost of $20M. These breakthrough achievements further strengthen our dedication to innovating flexible, scalable and accessible vaccines and biotherapeutics manufacturing solutions."

"Since my first stint in the vaccine industry in 1986, I have seen few technological breakthroughs bringing a genuine opportunityto change the fundamentals of vaccine manufacturing. The technology developed by Univercells heralds a new era in vaccine production," Dr. Pierre A. MORGON, Non-Executive Director and Advisor to the CEO, said. "The massive reduction of the upfront capital investment and of the manufacturing footprint required for bulk vaccine and biotherapeuticsproduction will shake the markets to their foundations and enable greater competition by lowering barriers to entry. Public health stands to gain handsomely from these new market dynamics, with biotherapeuticsand vaccines being available in large enough volumes and at affordable prices".

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