Charles River Partners with Magellan to Advance Stem Cell Therapy

Charles River Laboratories has partnered with Australian biotechnology company Magellan Stem Cells to support the development and clinical advancement of its stem cell therapies, including Zelestrocel, an investigational treatment for osteoarthritis.

Under the collaboration, Charles River will provide specialised biologics quality control, viral safety testing and development services to help Magellan advance its cell therapy programmes. The partnership will use Charles River’s current Good Manufacturing Practice (cGMP) testing capabilities, including next-generation sequencing (NGS), to support product quality and regulatory readiness.

Zelestrocel is Magellan’s lead allogeneic stem cell therapy candidate, designed as an off-the-shelf treatment for osteoarthritis. The company has completed its Phase I/II clinical trials and is preparing to begin a pivotal Phase III programme.

Magellan is also developing its manufacturing capabilities to support the next stages of clinical development and potential commercialisation. Its manufacturing facility in Melbourne, Australia, has received Good Manufacturing Practice certification from the country’s Therapeutic Goods Administration (TGA).

Charles River will provide cGMP next-generation sequencing services to assess viral safety and support the quality of Magellan’s cell therapy products. NGS technology allows researchers to analyse genetic material and detect potential pathogens, helping identify safety risks during the development of advanced therapies.

The approach is designed to support testing requirements while helping biotechnology companies prepare their products for regulatory review. Charles River’s services are intended to meet applicable quality and regulatory standards used in biologics development.

Kerstin Dolph, corporate senior vice president of global manufacturing at Charles River Laboratories, said the partnership would help expand the company’s support for innovative therapies and assist Magellan as it works to advance Zelestrocel towards potential commercialisation.

Julien Freitag, chief executive officer of Magellan Stem Cells, said access to advanced testing technologies and experienced development partners would be important as the company prepares for the next stage of Zelestrocel’s clinical development.

Nick Bliesner, chief operating officer of Magellan, added that Charles River’s cGMP NGS capabilities would support viral safety testing, product quality and regulatory preparation as the company advances the therapy.

NGS is increasingly being used in the development of biologics and advanced therapies because it can analyse large amounts of genetic information and help detect a wider range of potential contaminants. Charles River has also expanded its sequencing capabilities through the acquisition of Pathoquest, which specialises in NGS-based characterisation and quality control testing for biopharmaceutical products.

The collaboration highlights the growing need for specialised testing and manufacturing support as cell and gene therapies move from early research into later-stage clinical trials. By combining Magellan’s stem cell therapy development expertise with Charles River’s testing services, the companies aim to support Zelestrocel’s continued development and potential future availability for patients with osteoarthritis.

Zelestrocel remains investigational, and further clinical evaluation will be required to establish its safety and effectiveness before it can be approved for routine patient use.