Charles River, Medigen to Validate Virus Seed Bank for Next-Gen Enterovirus Vaccine

Editor’s Take: Such collaborations as this require scientific rigor and unity with global regulatory standards to ensure efficient advances.

Charles River Laboratories and Medigen Vaccine Biologics plan to characterize and validate a virus seed bank for a next-generation vaccine.

The collaboration centers on Medigen Vaccine Biologics (MVC)’s next-gen multivalent enterovirus vaccine, for which Charles River will contribute advanced analytics. Such platforms include next-generation sequencing that supports critical steps in chemistry, manufacturing, and controls (CMC).

Vaccine Details

MVC’s proprietary enterovirus 71 vaccine, Envacgen, has approvals in Taiwan and Vietnam. Now, MVC partners with Charles River, which lends global expertise in virology, biologics testing, non-clinical development, and regulatory science. The goals here are to speed development, enhance global regulatory readiness, and support Investigational New Drug (IND)-enabling non-clinical studies.

“By leveraging our experience in biologics, analytics, and safety, we are proud to partner with companies like MVC to achieve key milestones and drive innovation in the industry.”

• Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River Laboratories

“The success of a new vaccine relies not only on innovative technology,” MVC CEO Leo Lee said. “Also … establishing development strategies that meet global regulatory and scientific standards from the very beginning. We are pleased to collaborate strategically with Charles River and leverage its expertise in NGS and biologics testing.”

Kerstin Dolph, Charles River Corporate Senior Vice President, Global Manufacturing, said the company is lending biologics, analytics, and safety experience.

“We are excited to collaborate with MVC and apply our testing and NGS expertise for vaccine development,” Dolph said. “We are proud to partner with companies like MVC to achieve key milestones and drive innovation in the industry.”

Charles River and Medigen Commitment

Charles River and MVC say they share a commitment to high quality development, scientific rigor, and meeting global regulatory standards. These qualities, the companies add, contribute to an efficient advance of the enterovirus vaccine program.