Charles River Laboratories and Medigen Vaccine Biologics Corp Collaborate to Advance New Vaccine Development Programs Through Next Generation Sequencing

Key Terms

ngs technical

A laboratory method that reads large amounts of DNA or RNA quickly to identify genetic differences, mutations, or microbes, similar to scanning many pages of a book at once to find important words. Investors care because it drives diagnostics, drug discovery and personalized treatments, can create recurring revenue from testing services and instruments, and influences regulatory approvals, partnerships and market value in biotech and healthcare companies.

cmc regulatory

Chemistry, Manufacturing, and Controls (CMC) describes the technical documentation and processes that show how a drug or medical product is made, tested for consistent quality, and kept stable from batch to batch. Investors care because strong CMC means a product can be manufactured reliably at scale and meet regulatory standards—similar to proving a recipe can be cooked the same way in any kitchen before restaurants expand—affecting approval, production costs, and potential revenue.

ind-enabling regulatory

Ind-enabling describes the preclinical tests and safety work a drug candidate must pass before a company can ask regulators for permission to start human trials (an Investigational New Drug or IND filing). Think of it as the mechanical inspection and crash-testing a prototype car needs before it can legally be driven on public roads; for investors, successful ind-enabling work reduces technical and regulatory risk and makes clinical progress and potential value creation more likely.

gmp regulatory

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

ich q5a regulatory

An ICH Q5A guideline is an international regulatory document that sets expectations for evaluating and controlling viral contamination risks in biological products made from animal or human cell lines. It explains the types of tests, safety studies, and manufacturing controls companies should use, and matters to investors because it affects how quickly and cheaply biologics can move through development and approval—similar to safety checkpoints that shape production timelines and costs.

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Collaboration leverages NGS technologies to accelerate high-quality vaccine development, support global regulatory readiness, and help reduce animal testing

WILMINGTON, Mass.--(BUSINESS WIRE)-- Charles River Laboratories International, Inc. (NYSE: CRL) and Medigen Vaccine Biologics Corp. (MVC) collaborate on the characterization and validation of the virus seed bank for MVC's next-generation multivalent enterovirus vaccine. 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 MVC’s next-generation multivalent enterovirus vaccine. 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.

MVC's proprietary ENVACGEN^® Enterovirus 71 Vaccine 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.”

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, they 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 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.

Next Generation Sequencing
NGS is revolutionizing 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 meets regulatory requirements for accuracy, reliability, and compliance with GMP, FDA, EMA, and ICH Q5A and Q5B.

To further enhance 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.

Biologics Testing Solutions
Charles River’s Biologics Testing Solutions portfolio helps biopharmaceutical developers navigate complexity with confidence, providing comprehensive testing, scientific expertise, and regulatory guidance across the development lifecycle. As a one-stop global partner, Charles River combines industry-leading reliability, integrated GMP-compliant testing capabilities, and digital tools that help reduce risk, accelerate timelines, and support regulatory success across diverse biologic modalities. With the speed, science, and global infrastructure needed to keep programs moving forward, Charles River enables clients to advance life-changing therapies with greater certainty.

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. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260820417764/en/

Charles River Investor Contact:
Todd Spencer
Corporate Vice President,
Investor Relations
781.222.6455
todd.spencer@crl.com

Charles River Media Contact:
Amy Cianciaruso
Corporate Senior Vice President,
Chief Communications Officer
781.222.6168
amy.cianciaruso@crl.com

Medigen Vaccine Biologics Corp. Contact:
John Chen
Deputy Spokesperson
ir@medigenvac.com

Source: Charles River Laboratories International, Inc.