Medigen links up with Charles River in push to take enterovirus vaccine global

Charles River Laboratories (CRL) and Taiwan-based Medigen Vaccine Biologics are teaming up to prep Medigen’s multivalent enterovirus vaccine for global expansion. The collaboration is designed to characterize and validate the virus seed bank for Medigen’s vaccine and will leverage CRL’s analytical platforms, according to a Thursday release. CRL’s Next-Generation Sequencing will support the chemistry, manufacturing and controls steps to advance the vaccine program, including Medigen’s Envacgen enterovirus 71 vaccine, which has already been approved in Taiwan and Vietnam. The contagious virus is the leading cause of hand, foot and mouth disease and usually affects infants and young children. It can also lead to severe brain and nerve problems. “We are excited to collaborate with MVC and apply our testing and NGS expertise for vaccine development,” said Kerstin Dolph, CRL’s corporate senior vice president of global manufacturing in a release. “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.” CRL’s new CEO, Birgit Girshick, spoke with Fierce earlier this summer about the increasing importance of CRO collaboration with trial sponsors. The company will deploy its biologics testing and non-clinical development capabilities, while Medigen’s vaccine research expertise will help build the data needed for global regulatory readiness and support IND applications and future global clinical development. Beyond enterovirus, the companies will look for additional opportunities in other vaccine programs. “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,” Leo Lee, CEO of Medigen, said in a statement. “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.” Founded in 2012, Medigen has focused on vaccines and infectious diseases and received emergency use authorization in Taiwan during the COVID-19 pandemic.