Charles River Laboratories has agreed to provide testing and development services to Magellan Stem Cells as the Australian biotechnology company prepares a Phase III program for its experimental osteoarthritis treatment, Zelestrocel. Financial terms were not disclosed.
The collaboration will use Charles River’s next-generation sequencing services for viral safety testing, alongside biologics quality control, manufacturing release testing and development support. The work will follow current Good Manufacturing Practice standards and support Magellan’s clinical development and potential commercialization efforts.
Zelestrocel is an allogeneic, or donor-derived, stem cell therapy designed as an off-the-shelf treatment for osteoarthritis. Magellan recently completed Phase I/II trials and is preparing to launch a pivotal Phase III program, according to the announcement.
Magellan has also secured Good Manufacturing Practice certification from Australia’s Therapeutic Goods Administration for its Melbourne manufacturing facility. The company has incorporated manufacturing capacity into its development plans to support production as its programs advance.
Charles River’s sequencing-based testing will assess viral safety in cell and gene therapy products. The company said the approach forms part of its efforts to reduce reliance on animal testing while meeting regulatory requirements.
Magellan Chief Executive Julien Freitag said access to testing technologies and experienced partners would support the next stage of Zelestrocel’s development. Chief Operating Officer Nick Bliesner said the services would support product quality and regulatory preparations.
The companies said the collaboration would support Zelestrocel’s development and future stem cell and regenerative medicine programs.