Charles River collaborates with Medigen on next-generation multivalent enterovirus vaccine
As part of the agreement, Charles River will use technologies such as next-generation sequencing (NGS) to support chemistry, manufacturing and controls (CMC) activities associated with the vaccine programme.
USA—Charles River Laboratories International and Medigen Vaccine Biologics (MVC) have entered into a collaboration to support the characterisation and validation of the virus seed bank for MVC’s next-generation multivalent enterovirus vaccine.
The partnership will combine Charles River’s analytical and testing capabilities with Medigen’s vaccine development expertise.
As part of the agreement, Charles River will use technologies such as next-generation sequencing (NGS) to support chemistry, manufacturing and controls (CMC) activities associated with the vaccine programme.
Supporting Vaccine Development
The collaboration is designed to accelerate development of MVC’s new vaccine while helping align the programme with global regulatory requirements.
Charles River will provide expertise in biologics testing, virology, non-clinical development and regulatory science to support key stages of the development process.
The company will also provide analytical, testing and regulatory services required to characterise and validate the virus seed bank.
These activities are expected to generate data needed to support global investigational new drug (IND) applications and subsequent clinical development.
The two companies plan to integrate Charles River’s biologics testing and non-clinical development capabilities with Medigen’s research programme.
This approach will support IND-enabling non-clinical studies and help prepare the vaccine candidate for future clinical pathways.
Expanding enterovirus vaccine coverage
Medigen has previously received approval for its Envacgen Enterovirus 71 Vaccine in Taiwan and Vietnam.
Building on this regulatory experience, the company is developing a next-generation vaccine designed to provide broader protection against multiple enterovirus strains.
Enteroviruses comprise a group of viruses that can cause a range of illnesses, including hand, foot, and mouth disease and neurological complications.
The new multivalent vaccine programme seeks to expand protection beyond individual strains and address a broader range of enterovirus infections.
Charles River will support the programme by applying its experience in vaccine analytics, biologics testing, safety assessment and regulatory requirements.
Kerstin Dolph, senior vice-president of global manufacturing corporate at Charles River, said the company was pleased to collaborate with MVC and apply its testing and NGS expertise to the vaccine programme.
She added that Charles River’s experience in biologics, analytics and safety would help the companies reach important development milestones and advance vaccine innovation.
Charles River expands NGS capabilities
The collaboration also builds on Charles River’s recent expansion of its NGS testing capabilities through its acquisition of PathoQuest.
The acquisition strengthened the company’s ability to provide genomic and molecular testing services for biopharmaceutical development.
Through its broader biologics testing portfolio, Charles River provides analytical and regulatory support throughout the development lifecycle.
The company will apply these capabilities to help MVC advance its next-generation enterovirus vaccine and generate the data required for regulatory submissions and future clinical studies.
The companies have also expressed an interest in exploring additional vaccine development opportunities targeting emerging and established infectious diseases.
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