Charles River and Medigen Vaccine Biologics Partner to Advance Next-Generation Multivalent Enterovirus Vaccine
核心洞察
Charles River Laboratories and Medigen Vaccine Biologics (MVC) are collaborating on characterization and validation of the virus seed bank for MVC's next-generation multivalent enterovirus vaccine.
Charles River will apply Next-Generation Sequencing (NGS) and advanced analytical platforms to support Chemistry, Manufacturing, and Controls (CMC) activities for the vaccine program.
The partnership aims to generate robust data supporting IND applications, IND-enabling non-clinical studies, and future global clinical development.
Charles River Laboratories (CRL) and Medigen Vaccine Biologics Corp. (搜索) (MVC) have entered a collaboration focused on the characterization and validation of the virus seed bank for MVC's next-generation multivalent enterovirus vaccine. Under the agreement, Charles River will leverage its advanced analytical platforms, including Next-Generation Sequencing (NGS), to support critical steps of Chemistry, Manufacturing, and Controls (CMC) activities for the vaccine program.
The collaboration reflects both companies' shared commitment to high-quality development, scientific rigor, and accelerated alignment with global regulatory standards, while supporting the efficient advancement of the vaccine program.
Building on a Proven Vaccine Platform
MVC's proprietary Envacgen Enterovirus 71 Vaccine (搜索) has been approved in Taiwan and Vietnam, demonstrating the company's proven capability to develop and manufacture vaccines that meet international quality standards. Building on this success, MVC is advancing the development of its next-generation multivalent enterovirus vaccine and selected Charles River as its strategic partner to accelerate the program by leveraging the company's global expertise in virology, biologics testing, non-clinical development, and regulatory science.
"We are excited to collaborate with MVC and apply our testing and NGS expertise for vaccine development," said Kerstin Dolph, corporate senior vice president, global manufacturing, Charles River. "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."
Supporting IND-Enabling Studies and Global Development
Through this collaboration, Charles River and MVC will combine Charles River's leading global biologics testing and non-clinical development capabilities with MVC's established vaccine research expertise to accelerate development of the next-generation multivalent enterovirus vaccine, enhance global regulatory readiness, and support IND-enabling non-clinical studies. The companies aim to generate robust data to support IND applications and future global clinical development.
Building on this foundation, the partners plan to explore additional opportunities across other vaccine programs to jointly innovate vaccines, tackling global infectious diseases and unmet medical needs.
"MVC has demonstrated strong capabilities in innovative vaccine development, and we are pleased to support its next-generation multivalent enterovirus vaccine program. By leveraging Charles River's expertise in virology, toxicology, animal models, and non-clinical development, we look forward to supporting MVC in achieving key development milestones, accelerating this innovative vaccine into clinical development, and jointly advancing global public health," said Dolph.
The Role of Next-Generation Sequencing
Next-generation sequencing (NGS) is transforming the way advanced therapeutics are characterized and tested, ensuring high-quality products are delivered to patients. NGS has transformed the genetic analysis and pathogen detection landscape with its high throughput, scalability, and speed. Charles River's CGMP NGS testing services accelerate development timelines without compromising safety and meet regulatory requirements for accuracy, reliability, and compliance with GMP, FDA, EMA, and ICH Q5A and Q5B.
To further enhance its NGS capabilities, Charles River has acquired Pathoquest, a leader in NGS solutions for in vitro characterization and quality control testing of biopharmaceutical products. The acquisition enables Charles River to deliver even faster and more advanced sequencing-based testing to clients across the development pipeline.
Strategic Outlook
"The success of a new vaccine relies not only on innovative technology but also on establishing development strategies that meet global regulatory and scientific standards from the very beginning. We are pleased to collaborate strategically with Charles River and leverage its expertise in NGS and biologics testing to establish a high-quality vaccine development process aligned with international regulatory expectations. We also look forward to extending these technology platforms and collaborative approaches to future vaccine development programs, further strengthening MVC's competitiveness in innovative vaccine development and global market expansion," said Leo Lee, CEO of Medigen Vaccine Biologics.
A key marker to watch is progress on IND-enabling non-clinical packages for Medigen's multivalent enterovirus vaccine, including successful completion of seed bank validation and NGS-driven CMC data that feeds into an IND filing. Clear evidence that this work converts into future projects or additional vaccine programs would test how scalable this partnership really is for Charles River.
Founded in 2012, Medigen Vaccine Biologics Corp. (搜索) 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.