Charles River Laboratories International and Medigen Vaccine Biologics Corp (MVC) are joining forces to accelerate development of MVC’s next-generation multivalent enterovirus vaccine.
This, by combining advanced genetic testing with vaccine-development expertise to strengthen the program’s path toward clinical development.
Under the collaboration, Charles River will characterize and validate the virus seed bank and deploy advanced analytical technologies, including Next-Generation Sequencing (NGS), to support critical Chemistry, Manufacturing, and Controls (CMC) activities.
The partnership is designed to generate robust data for regulatory submissions, support IND-enabling non-clinical studies and help align the vaccine program with global regulatory and scientific standards.
MVC brings an established track record in enterovirus vaccine development. Its proprietary ENVACGEN Enterovirus 71 Vaccine has been approved in Taiwan and Vietnam, demonstrating the company’s ability to develop and manufacture vaccines meeting international quality standards.
Building on that foundation, MVC selected Charles River as a strategic partner for its next-generation multivalent vaccine, tapping the company’s global 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 will combine Charles River’s global biologics testing and non-clinical development capabilities with MVC’s vaccine research expertise. The goal is to accelerate development, strengthen global regulatory readiness and support IND-enabling studies as MVC advances the vaccine toward clinical development.
The partnership could also extend beyond the current program, with the companies planning to explore additional vaccine-development opportunities targeting infectious diseases and unmet medical needs.
"MVC has demonstrated strong capabilities in innovative vaccine development, and we are pleased to support its next-generation multivalent enterovirus vaccine program. 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," said Dolph.
For MVC, the collaboration is also about building a development platform capable of meeting regulatory expectations 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. 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.
"We also look forward to extending these technology platforms and collaborative approaches to future vaccine development programs, further strengthening MVC's competitiveness in innovative vaccine development and global market expansion,” said Leo Lee, CEO of Medigen Vaccine Biologics.
At the heart of the collaboration is Next-Generation Sequencing, a technology increasingly central to the characterization and quality control of advanced therapeutics.
NGS enables high-throughput genetic analysis and pathogen detection with greater speed and scalability, helping developers generate critical data while maintaining rigorous quality and safety standards.
Charles River’s CGMP NGS testing services are designed to accelerate development while meeting regulatory expectations for accuracy, reliability and compliance with GMP, FDA, EMA and ICH Q5A and Q5B requirements.
Charles River has further expanded its sequencing capabilities through the acquisition of Pathoquest, a specialist in NGS-based in vitro characterization and quality-control testing for biopharmaceutical products. The move strengthens the company’s ability to provide sequencing-based testing across the development pipeline.
The collaboration also draws on Charles River’s broader Biologics Testing Solutions portfolio, which provides testing, scientific expertise and regulatory support across the biopharmaceutical development lifecycle.
