Charles River Laboratories and Medigen Vaccine Biologics Collaborate to Advance Next-Generation Multivalent Enterovirus Vaccine
Charles River Laboratories and Medigen Vaccine Biologics Corp. (MVC) have entered into a strategic collaboration focused on the characterization and validation of the virus seed bank supporting MVC’s next-generation multivalent enterovirus vaccine. The partnership is designed to strengthen key Chemistry, Manufacturing, and Controls (CMC) activities and help prepare the vaccine candidate for future clinical development and regulatory submissions.
As part of the collaboration, Charles River will apply its expertise in virology, biologics testing, non-clinical development and regulatory science, together with advanced analytical technologies such as Next-Generation Sequencing (NGS). These capabilities will support the characterization of the virus seed bank and provide critical analytical information required during the development of MVC’s vaccine program.
The collaboration brings together Charles River’s global testing infrastructure and scientific expertise with MVC’s established capabilities in vaccine research and manufacturing. The companies intend to generate high-quality data that can support regulatory readiness, IND-enabling activities and the eventual global clinical development of the next-generation vaccine.
Building on MVC’s Vaccine Development Experience
Medigen Vaccine Biologics has established experience in developing and manufacturing vaccines for infectious diseases. The company’s proprietary ENVACGEN® Enterovirus 71 Vaccine has received approval in Taiwan and Vietnam, demonstrating MVC’s ability to develop vaccine products that meet applicable quality and regulatory requirements.
Building on this experience, MVC is now advancing a next-generation multivalent enterovirus vaccine designed to expand protection against enteroviruses. The company selected Charles River as a strategic development partner to help accelerate the program and strengthen its analytical and regulatory foundation.
The collaboration is particularly focused on ensuring that critical development activities are supported by robust scientific characterization from an early stage. Proper characterization of vaccine materials, including virus seed banks, is an essential component of vaccine development because it can help establish consistency, identity, purity and safety while providing information required to support manufacturing and regulatory assessments.
By incorporating advanced analytical methods into the development process, MVC and Charles River aim to establish a comprehensive data package that can support subsequent stages of the vaccine program.
Applying Next-Generation Sequencing Technology
A key component of the collaboration is the use of Next-Generation Sequencing, commonly known as NGS. NGS has become an increasingly important technology across biopharmaceutical development because it enables researchers to analyze genetic material rapidly and at high throughput.
For vaccine development, sequencing technologies can provide detailed information about viral materials and help researchers characterize biological products with a high level of resolution. NGS can also support the identification and assessment of potential contaminants and other genetic characteristics relevant to product quality and safety.
Charles River plans to leverage its NGS capabilities to support MVC’s virus seed bank characterization and related CMC activities. The goal is to provide reliable analytical data while helping the vaccine program move efficiently toward later development milestones.
Charles River’s cGMP NGS testing services are designed to support biopharmaceutical developers with sequencing-based characterization and testing while maintaining compliance with applicable regulatory expectations. The company’s NGS capabilities are intended to address requirements relating to accuracy, reliability, quality and regulatory compliance, including expectations associated with GMP, FDA, EMA and relevant ICH guidelines.
The use of NGS as part of the vaccine development strategy reflects the broader evolution of analytical technologies in the pharmaceutical and biotechnology industries. Advanced sequencing can complement traditional testing approaches and provide developers with additional information to support product characterization and quality control.
Expansion of Charles River’s NGS Capabilities
Charles River has continued to strengthen its sequencing and analytical capabilities to support clients developing vaccines and other biologic products. The company’s acquisition of Pathoquest, a specialist in NGS-based solutions for in vitro characterization and quality control testing of biopharmaceutical products, has further expanded its capabilities in this area.
The addition of Pathoquest’s expertise enables Charles River to offer more advanced sequencing-based testing services across different stages of the biopharmaceutical development lifecycle. This broader platform can help developers obtain critical analytical information while potentially reducing the time required to complete certain testing activities.
For MVC, access to Charles River’s NGS infrastructure and scientific expertise is expected to provide additional support as the company advances its multivalent enterovirus vaccine toward clinical development.
Supporting CMC and Regulatory Readiness
CMC development represents a critical component of vaccine development. Before a new vaccine can advance into clinical trials and ultimately toward commercialization, developers must establish appropriate processes and analytical controls to demonstrate that the product can be consistently manufactured and adequately characterized.
The Charles River-MVC collaboration is intended to support these requirements by combining advanced analytical testing with scientific and regulatory expertise.
The companies plan to generate robust data that can contribute to Investigational New Drug (IND) applications and future global clinical development. In addition to analytical characterization, Charles River is expected to contribute expertise in non-clinical development, including virology, toxicology and animal models.
This integrated approach is intended to help MVC address multiple development requirements through a coordinated strategy rather than treating analytical testing and non-clinical development as separate activities.
The companies also expect the collaboration to improve the program’s readiness for regulatory interactions in different markets. Establishing development strategies that align with international regulatory expectations early in the process can help minimize potential delays and provide a stronger foundation for subsequent clinical and manufacturing activities.
Charles River Highlights Strategic Partnership
Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing at Charles River, expressed enthusiasm about the collaboration and the opportunity to apply the company’s testing and sequencing capabilities to MVC’s vaccine program.
According to Dolph, Charles River’s experience in biologics, analytics and safety positions the company to support vaccine developers as they progress through important development milestones. The collaboration with MVC reflects Charles River’s broader strategy of partnering with biotechnology and pharmaceutical companies to provide scientific and technical capabilities that can help advance innovative products.
Dolph also emphasized Charles River’s expertise in virology, toxicology, animal models and non-clinical development. These capabilities are expected to complement MVC’s vaccine development experience and help the program move toward clinical evaluation.
MVC Emphasizes Global Development Strategy
Leo Lee, CEO of Medigen Vaccine Biologics, said the development of a successful vaccine requires more than innovative scientific technology. According to Lee, development strategies must incorporate appropriate scientific and regulatory considerations from the earliest stages of the program.
MVC views its collaboration with Charles River as an opportunity to strengthen its development process through access to NGS and biologics testing expertise. The company intends to use these technologies to establish a vaccine development framework aligned with international regulatory expectations.
Lee also indicated that MVC plans to explore ways to extend the technologies and collaborative model developed through this partnership to additional vaccine programs in the future.
Such expansion could potentially help MVC strengthen its position in innovative vaccine development while supporting its broader ambitions for international market expansion.
Comprehensive Biologics Testing Support
Beyond NGS, Charles River offers a broad portfolio of Biologics Testing Solutions designed to support biopharmaceutical developers across the product development lifecycle. These services encompass scientific testing, regulatory support and specialized analytical capabilities for a range of biologic modalities.
By integrating testing capabilities across different stages of development, Charles River aims to help companies manage complex development requirements while reducing potential risks and supporting efficient regulatory submissions.
For vaccine developers such as MVC, access to a global testing partner can be particularly valuable because vaccine programs require extensive characterization, safety evaluation, quality testing and regulatory documentation.
The collaboration therefore extends beyond a single analytical testing activity. It represents a broader effort to combine vaccine development expertise with global analytical, non-clinical and regulatory capabilities.
Potential to Support Future Vaccine Programs
The companies intend to use their collaboration on the next-generation multivalent enterovirus vaccine as a foundation for exploring additional opportunities in vaccine development. Future collaborations could potentially involve other infectious disease programs and technologies where advanced sequencing, biologics testing and non-clinical development expertise are required.
Enteroviruses represent an important area of public health interest, and continued vaccine innovation could contribute to efforts to address diseases for which broader or improved protection is needed.
Through the partnership, MVC and Charles River aim to advance the current vaccine program while establishing a development framework that could be applied to future candidates.
The collaboration underscores the growing importance of integrated analytical technologies in modern vaccine development. NGS, advanced biologics testing, non-clinical studies and regulatory science can collectively provide developers with the data needed to make informed decisions throughout the product lifecycle.
Advancing Toward Clinical Development
The partnership between Charles River Laboratories and Medigen Vaccine Biologics marks another step in MVC’s efforts to advance its next-generation multivalent enterovirus vaccine. By combining MVC’s vaccine research and manufacturing experience with Charles River’s global expertise in NGS, virology, biologics testing and non-clinical development, the companies are seeking to accelerate the program while maintaining a strong focus on quality and regulatory readiness.
The characterization and validation of the virus seed bank will form an important part of this effort. The resulting analytical and non-clinical data are expected to contribute to the development package required for future IND submissions and clinical studies.
As the program progresses, the companies will continue to evaluate opportunities to expand their collaboration into other vaccine initiatives. Their shared objective is to apply advanced technologies and scientific expertise to develop innovative vaccines capable of addressing infectious diseases and unmet global healthcare needs.
With its established experience in enterovirus vaccine development and Charles River’s extensive global testing infrastructure, MVC is positioning the next-generation program for continued advancement toward clinical development and, potentially, broader international availability.
About Medigen Vaccine Corp
Founded in 2012, MVC is dedicated to combating infectious diseases through the development and mass production of innovative vaccines. Utilizing advanced cell-culture technology and a PIC/S GMP-certified biopharmaceutical facility, MVC notably served as the only domestic manufacturer to receive Emergency Use Authorization (EUA) in Taiwan during the COVID-19 pandemic, demonstrating its robust R&D capabilities.
MVC’s commercialized ENVACGEN®, an Enterovirus 71 Vaccine, has obtained regulatory approvals in Taiwan and Vietnam, with active market expansion in Southeast Asia. Building on this foundation, MVC continues to deepen its research in enterovirus vaccines by actively driving the development of a next-generation multivalent enterovirus vaccine. By aligning with global strategic partners, MVC aims to build a comprehensive enterovirus vaccine portfolio with the vision of becoming a global leader in enterovirus vaccine innovation.
About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them.