Charles River Laboratories International and Medigen Vaccine Biologics (MVC) have entered a collaboration to support the characterisation along with validation of the virus seed bank for the latter’s next-generation multivalent enterovirus vaccine.
Utilising its analytical platforms such as next-generation sequencing (NGS), Charles River will assist with chemistry, manufacturing, and controls (CMC) activities related to the vaccine’s development.
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The agreement aims to accelerate the progression of the new enterovirus vaccine.
It seeks to leverage the global expertise that Charles River provides in areas, including biologics testing, virology, non-clinical development, and regulatory science.
The collaboration is intended to align development with global regulatory expectations and advance the vaccine programme.
Medigen Vaccine Biologics has previously secured approval for its Envacgen Enterovirus 71 Vaccine in Taiwan and Vietnam.
Based on this prior regulatory experience, the company is moving forward with the development of a next-generation vaccine to address broader enterovirus strains.
As part of this process, Charles River has been selected to supply the necessary analytical, testing, and regulatory support.
Charles River global manufacturing corporate senior vice-president Kerstin Dolph said: “We are excited to collaborate with MVC and apply our testing and NGS expertise for vaccine development.
“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 two companies plan to integrate Charles River’s biologics testing and non-clinical development capabilities with Medigen’s research in order to accelerate development and support investigational new drug (IND)-enabling non-clinical studies.
The partnership also seeks to generate data for global IND applications and future clinical pathways. They have indicated a shared interest in exploring further vaccine development opportunities in response to global infectious diseases.
Charles River has recently enhanced its NGS testing capabilities through the acquisition of Pathoquest. The company’s biologics testing solutions offer expertise and regulatory support across the entire developmental life cycle for clients worldwide.
