WILMINGTON, Mass. — Charles River Laboratories International Inc. and Medigen Vaccine Biologics Corp. have entered a collaboration to support development of Medigen’s next-generation multivalent enterovirus vaccine using advanced analytical technologies, including next-generation sequencing.
Under the collaboration, Charles River will help characterize and validate the virus seed bank for the vaccine and support Chemistry, Manufacturing and Controls activities. The companies said the work is intended to accelerate vaccine development, strengthen regulatory readiness and generate data to support future clinical studies.
Medigen’s ENVACGEN Enterovirus 71 Vaccine has already been approved in Taiwan and Vietnam. Building on that program, the company is developing a multivalent enterovirus vaccine and selected Charles River for its expertise in virology, biologics testing, non-clinical development and regulatory science.
“We are excited to collaborate with MVC and apply our testing and NGS expertise for vaccine development,” said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River. “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.”
The companies plan to combine Charles River’s biologics testing and non-clinical development capabilities with Medigen’s vaccine research expertise to support IND-enabling studies and future global clinical development.
“MVC has demonstrated strong capabilities in innovative vaccine development, and we are pleased to support its next-generation multivalent enterovirus vaccine program,” Dolph said. “By leveraging Charles River’s expertise in virology, toxicology, animal models, and non-clinical development, we look forward to supporting MVC in achieving key development milestones, accelerating this innovative vaccine into clinical development, and jointly advancing global public health.”
Leo Lee, CEO of Medigen Vaccine Biologics, said the partnership is designed to establish a vaccine development process that meets international scientific and regulatory standards from the outset.
“The success of a new vaccine relies not only on innovative technology but also on establishing development strategies that meet global regulatory and scientific standards from the very beginning,” Lee said. “We are pleased to collaborate strategically with Charles River and leverage its expertise in NGS and biologics testing to establish a high-quality vaccine development process aligned with international regulatory expectations.”
Charles River said its next-generation sequencing services are used for genetic analysis, pathogen detection and quality-control testing of biopharmaceutical products. The company has also expanded its NGS capabilities through its acquisition of Pathoquest.
The companies said they may explore additional vaccine development programs in the future, including projects targeting infectious diseases and other unmet medical needs.
