Charles River teams up with Magellan Stem Cells to support development of off the shelf osteoarthritis therapy Zelestrocel

Charles River Laboratories International and Magellan Stem Cells, a private Australian biotech and cell therapy company, have announced a collaboration to support the development and clinical progress of Magellan’s stem cell based therapies and regenerative medicine products. Charles River will contribute its expertise in biologics quality control, cGMP viral and release testing, and wider development support. The companies say that pairing Charles River’s testing and development services with Magellan’s work in cell therapy development, manufacturing and clinical use is intended to drive innovation and create shared value.

Charles River will provide viral safety testing using cGMP next generation sequencing for cell and gene therapy, which supports a high quality development process in line with international regulatory standards. The company says the service reflects its commitment to the 3Rs (replacement, reduction and refinement) through its Alternative Methods Advancement Project. The project develops and applies new approach methodologies and other strategies to reduce reliance on animal testing while supporting efficient product development.

Magellan recently completed Phase I/II trials of its lead allogeneic, off the shelf stem cell candidate, Zelestrocel, in osteoarthritis and is preparing to start a pivotal Phase III programme. It has also built scalable manufacturing into its development pathway. Its Melbourne facility holds GMP certification from Australia’s Therapeutic Goods Administration, making it one of only four GMP certified cell therapy manufacturing facilities in the country.

Kerstin Dolph, corporate senior vice president for global manufacturing at Charles River, said working with organisations at the forefront of innovation lets the company expand its GMP testing capabilities and help speed safe, compliant therapies to patients. She said Charles River is excited to support Magellan as it works to take Zelestrocel from the clinic towards potential commercialisation.

Julien Freitag, associate professor and chief executive officer of Magellan Stem Cells, said that as the company prepares for the next stage of Zelestrocel’s development, access to advanced testing technologies and experienced partners is critical to its success.

Nick Bliesner, chief operating officer of Magellan, said Charles River’s GMP next generation sequencing offers an innovative approach to viral safety testing that supports both product quality and regulatory readiness. He said the collaboration strengthens Magellan’s ability to advance Zelestrocel towards commercialisation with confidence.

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