Charles River Laboratories International and Medigen Vaccine Biologics Corp. have formed a collaboration to support development of Medigen’s next-generation multivalent enterovirus vaccine through next-generation sequencing and other analytical and non-clinical capabilities.
Under the agreement, Charles River will help characterize and validate the virus seed bank for the vaccine candidate. The company will use its analytical platforms, including next-generation sequencing, to support chemistry, manufacturing and controls activities for the program.
The companies said the collaboration is designed to accelerate high-quality vaccine development, strengthen readiness for global regulatory requirements and support investigational new drug-enabling non-clinical studies. They aim to generate data for future IND applications and global clinical development.
Medigen selected Charles River based on the laboratory services provider’s capabilities in virology, biologics testing, non-clinical development and regulatory science. Charles River will combine those capabilities with Medigen’s vaccine research experience as the companies advance the multivalent enterovirus program.
Kerstin Dolph, corporate senior vice president of global manufacturing at Charles River, said the company will apply its testing and sequencing expertise to help Medigen reach development milestones. She said Charles River’s experience includes biologics, analytics and safety work.
Medigen Chief Executive Leo Lee said vaccine programs require development strategies aligned with international regulatory and scientific standards from the outset. He said the company plans to use Charles River’s next-generation sequencing and biologics-testing expertise to establish a high-quality vaccine development process.
Next-generation sequencing is used in the genetic analysis and detection of pathogens. Charles River said its current good manufacturing practice sequencing services are intended to speed development while supporting standards for accuracy, reliability and compliance with GMP, FDA, European Medicines Agency and International Council for Harmonisation requirements.
Medigen’s existing ENVACGEN enterovirus 71 vaccine has received approvals in Taiwan and Vietnam. The company said that experience demonstrates its ability to develop and manufacture vaccines to international quality standards and provides a foundation for its multivalent enterovirus program.
The companies also said they intend to explore further collaboration across additional vaccine programs. Those efforts could seek to address infectious diseases and unmet medical needs while supporting Medigen’s broader vaccine portfolio and international expansion.