Under the terms of a new agreement, Kaneka Eurogentec S.A. will help produce INOVIO’s COVID-19 vaccine candidate, INO-4800, joining a global manufacturing consortium that also includes Thermo Fisher Scientific, Richter-Helm BioLogics, and Ology Biosciences.
“Our partnership with Kaneka Eurogentec, one of the world’s largest and most experienced plasmid manufacturers, provides additional scale to our growing global manufacturing coalition,” Dr. J. Joseph Kim, INOVIO president and CEO, said. “Kaneka Eurogentec will be a crucial member of INOVIO’s global manufacturing consortium, supporting our plans to produce, manufacture, and scale our COVID-19 vaccine candidate, INO-4800.”
INOVIO is currently in the midst of a phase two trial of INO-4800, as part of a larger phase 2/3 clinical trial known as INNOVATE. The randomized, blinded, placebo-controlled safety, and efficacy trial is focused on adults and benefits from funding by the U.S. Department of Defense.
As to manufacturing, an advantage shown by INO-4800 is a shelf life of approximately five years greater when refrigerated. It also boasts stability of more than 30 days at high temperatures of around 98 degrees Fahrenheit and for more than a year at room temperature. No freezing is necessary for transportation or storage, giving it serious promise for wide-scale, global distribution.
Kaneka will now be a key part of that distribution.
“Kaneka Eurogentec brings a wealth of DNA plasmid manufacturing expertise and innovation to INOVIO’s global consortium to manufacture INO-4800,” said Robert Juba Jr., INOVIO’s Senior Vice President of Biological Manufacturing and Clinical Supply Management. “We look forward to working with them to utilize their state-of-the-art, large-scale manufacturing capabilities towards our goal of producing hundreds of millions of doses of INO-4800 for worldwide distribution.”
Both for Kaneka and the other manufacturers involved in the coalition, selections were based on commercial GMP standards and the companies’ capabilities to support INOVIO’s future global manufacturing needs for its whole portfolio of DNA medicines and vaccines.