Charles River and Medigen Partner on Next-Generation Enterovirus Vaccine

Charles River Laboratories and Medigen Vaccine Biologics have entered into a collaboration to support the development of Medigen’s next-generation multivalent enterovirus vaccine.

Under the agreement, Charles River will help characterize and validate the virus seed bank for the vaccine. The company will use its analytical testing capabilities, including next-generation sequencing (NGS), to support key Chemistry, Manufacturing and Controls (CMC) activities.

The collaboration is intended to help Medigen generate the data needed for future regulatory submissions and clinical development while aligning the vaccine program with international quality and regulatory standards.

Medigen already has experience in enterovirus vaccine development through its ENVACGEN Enterovirus 71 Vaccine, which has been approved in Taiwan and Vietnam. The company is now working on a multivalent vaccine designed to provide broader protection against multiple enterovirus strains.

Charles River was selected as a strategic partner because of its expertise in virology, biologics testing, non-clinical development and regulatory science. The companies will combine these capabilities with Medigen’s vaccine research and development experience.

The partnership will support several stages of the vaccine program, including virus seed bank characterization, analytical testing and IND-enabling non-clinical studies. The companies aim to generate data that can support Investigational New Drug (IND) applications and future clinical trials in global markets.

Kerstin Dolph, Corporate Senior Vice President of Global Manufacturing at Charles River, said the company will apply its experience in biologics, analytics and safety testing to support important development milestones for the vaccine.

Leo Lee, CEO of Medigen Vaccine Biologics, said working with Charles River will help the company build a vaccine development process that meets international scientific and regulatory expectations from an early stage.

A key part of the collaboration will be the use of next-generation sequencing. NGS allows researchers to analyze genetic material at high speed and scale, making it an important tool for identifying and characterizing viruses and checking the quality of biological products.

Charles River provides NGS testing services designed to support biopharmaceutical development and meet requirements from regulators including the U.S. Food and Drug Administration and European Medicines Agency. The company has also strengthened its NGS capabilities through the acquisition of PathoQuest, which specializes in sequencing-based testing for biopharmaceutical products.

In addition to NGS, Charles River will provide access to its broader biologics testing and non-clinical development capabilities. These include virology, toxicology and animal model services that can help support vaccine development before clinical testing.

The companies also plan to explore additional opportunities to work together on other vaccine programs. Their longer-term goal is to use their combined expertise to support the development of new vaccines for infectious diseases and address unmet global healthcare needs.

The collaboration highlights the growing role of advanced analytical technologies such as NGS in vaccine development, particularly as companies work to improve product quality, speed up development and prepare programs for global regulatory review.