Wilmington, Massachusetts, August 20, 2026
Charles River Laboratories International and Medigen Vaccine Biologics Corp. (MVC) have entered into a strategic collaboration to support the development of MVC’s next-generation multivalent enterovirus vaccine through advanced Next-Generation Sequencing (NGS) and biologics testing capabilities. Under the collaboration, Charles River will support the characterization and validation of MVC’s virus seed bank, an important Chemistry, Manufacturing and Controls (CMC) activity for advancing the vaccine program toward clinical development. The partnership is designed to generate high-quality analytical data that can support global regulatory readiness, IND-enabling activities and future clinical development. Charles River will bring its expertise in virology, biologics testing, non-clinical development, toxicology and regulatory science to MVC’s vaccine program, while MVC contributes its established experience in vaccine research and manufacturing. For cGxP.wire readers, the key development is the integration of NGS-based characterization into vaccine CMC and quality-control activities, helping developers obtain detailed genetic information about vaccine-related materials and strengthen the data package required for regulatory progression. The collaboration also reflects growing industry interest in analytical technologies that can improve development efficiency while potentially supporting strategies aimed at reducing reliance on animal testing. Rather than representing a vaccine approval or clinical efficacy milestone, the agreement focuses on strengthening the development, characterization and regulatory foundation of MVC’s next-generation vaccine candidate.
NGS Strengthens Vaccine Characterization and CMC
Next-Generation Sequencing is central to the collaboration, with Charles River applying its advanced analytical capabilities to support characterization and validation activities associated with MVC’s virus seed bank. NGS enables high-throughput genetic analysis and can provide detailed information relevant to the characterization of biological materials used during vaccine development. For a next-generation multivalent enterovirus vaccine, establishing robust analytical characterization is an important component of the broader CMC development process, particularly as programs move toward regulatory submissions and clinical testing. Charles River’s NGS capabilities are intended to help generate reliable data supporting vaccine quality, safety and consistency while aligning development activities with international regulatory expectations. The company’s NGS testing services are designed for regulated biopharmaceutical development and are intended to support requirements associated with GMP, FDA, EMA and ICH Q5A and Q5B frameworks. Charles River has also strengthened its sequencing capabilities through its acquisition of Pathoquest, expanding its ability to provide NGS-based testing for in vitro characterization and quality-control applications. For MVC, incorporating these capabilities into the development program could help establish a more comprehensive analytical package as the vaccine advances toward IND-enabling non-clinical studies and future clinical development. The collaboration demonstrates how sequencing technologies are increasingly becoming integrated into the quality and characterization workflows supporting modern vaccine development.
MVC Advances Next-Generation Multivalent Enterovirus Vaccine
The collaboration supports MVC’s development of a next-generation multivalent enterovirus vaccine, building on the company’s existing experience with enterovirus vaccine development. MVC’s ENVACGEN Enterovirus 71 Vaccine has received regulatory approval in Taiwan and Vietnam, providing an established foundation for the company’s vaccine research and manufacturing activities. The next-generation program is intended to expand MVC’s enterovirus vaccine capabilities through a multivalent approach, while the partnership with Charles River is focused on advancing the analytical and non-clinical development requirements associated with the program. Charles River will contribute expertise spanning virology, biologics testing, toxicology, animal models and non-clinical development, supporting MVC as it works toward future clinical-stage milestones. The companies intend to generate robust data that can support IND applications and global clinical development, with additional opportunities for collaboration across other vaccine programs also expected to be explored. From a cGxP.wire perspective, the significance of the agreement lies in the development infrastructure behind the vaccine rather than in clinical results. Characterization, validation and regulatory-quality testing are critical steps before a vaccine candidate can progress into human studies, and the partnership is structured around strengthening those activities. The collaboration therefore highlights the increasing role of specialized analytical and testing partners in accelerating vaccine programs while maintaining rigorous quality standards.
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Charles River Supports Global Regulatory Readiness
The partnership is also focused on helping MVC build a development strategy aligned with international scientific and regulatory expectations from an early stage. By combining Charles River’s global biologics testing and non-clinical development infrastructure with MVC’s vaccine expertise, the companies aim to streamline activities needed for regulatory progression and future clinical development. The collaboration includes support for IND-enabling non-clinical studies, analytical characterization and broader vaccine development activities, creating an integrated pathway toward potential clinical testing. Charles River’s role is particularly relevant to the growing complexity of vaccine development, where developers must demonstrate product identity, quality, consistency and safety through validated analytical approaches. NGS can contribute to this process by providing detailed genetic characterization capabilities that complement conventional testing strategies. The companies also indicated that they intend to explore additional collaborative opportunities across other vaccine programs, potentially extending the partnership beyond the current enterovirus project. No clinical efficacy, regulatory approval or human trial milestone was announced for the next-generation vaccine in this collaboration, meaning the immediate focus remains on development and testing infrastructure. For the vaccine industry, however, the agreement illustrates how advanced sequencing, CMC expertise and global regulatory capabilities are being combined to support faster and more robust development of emerging infectious-disease vaccines.
Source:Charles River Laboratories press relese
