- Charles River Laboratories has partnered with Australian biotech company Magellan Stem Cells to support the development and clinical advancement of its stem cell-based therapies, including Zelestrocel.
- Charles River will provide current Good Manufacturing Practice (cGMP) next-generation sequencing (NGS) viral safety testing as Magellan prepares to advance Zelestrocel, an investigational osteoarthritis therapy, into Phase III clinical development.
Charles River Laboratories International, Inc. has entered into a collaboration with Magellan Stem Cells to support the development and clinical advancement of the Australian company’s stem cell-based therapies and regenerative medicine programs. The partnership will combine Charles River’s biologics quality control, cGMP viral and release testing, and development services with Magellan’s cell therapy development and manufacturing capabilities.
Under the agreement, Charles River will provide cGMP next-generation sequencing (NGS) viral safety testing for cell and gene therapy products. The service is intended to support therapy development in line with international regulatory standards. Charles River said its NGS offering also supports its Alternative Methods Advancement Project (AMAP), which develops new approach methodologies and other strategies to reduce reliance on animal testing.
Magellan has completed Phase I/II clinical trials of Zelestrocel, its proprietary allogeneic, off-the-shelf stem cell therapy candidate for osteoarthritis, and is preparing to launch a pivotal Phase III program. The company has also integrated scalable manufacturing into its development pathway and secured Good Manufacturing Practice certification from Australia’s Therapeutic Goods Administration for its manufacturing facility in Melbourne.
“The collaboration would expand the company’s GMP testing capabilities and support Magellan as it works to advance Zelestrocel toward potential commercialization.”
Charles River Corporate Senior Vice President of Global Manufacturing Kerstin Dolph
“Access to advanced testing technologies and experienced partners was important as the program moves into its next stage.”
Magellan CEO Associate Professor Julien Freitag
Magellan COO Nick Bliesner said Charles River’s GMP NGS capabilities provide an approach to viral safety testing that supports product quality and regulatory readiness. The collaboration is intended to help Magellan advance Zelestrocel toward potential commercialization.
