WILMINGTON, Mass. — Charles River Laboratories International, Inc. (NYSE: CRL) has announced a collaboration with Australian biotechnology company Magellan Stem Cells to support the development and potential commercialization of stem cell-based therapies, including an investigational treatment for osteoarthritis.
The partnership will combine Charles River’s expertise in biologics testing, viral safety assessment and regulatory compliance with Magellan’s cell therapy development and manufacturing capabilities.
Under the agreement, Charles River will provide next-generation sequencing (NGS) services and other testing support to help Magellan advance its lead stem cell therapy candidate, Zelestrocel, toward late-stage clinical development and potential regulatory approval.
“Working with organizations at the forefront of innovation allows us to expand our GMP testing capabilities and help accelerate the delivery of safe, compliant therapies to patients,” said Kerstin Dolph, Corporate Senior Vice President of Global Manufacturing at Charles River. “We are excited to support Magellan as they work towards advancing Zelestrocel from the clinic to potential commercialization.”
Magellan recently completed Phase 1/2 clinical trials of Zelestrocel, an allogeneic, off-the-shelf stem cell therapy being developed for osteoarthritis, and is preparing to begin a pivotal Phase 3 clinical trial.
The company has also established manufacturing operations in Melbourne, Australia, where its facility has received Good Manufacturing Practice certification from the Therapeutic Goods Administration.
Charles River will use its current Good Manufacturing Practice-compliant NGS technology to conduct viral safety testing and support the quality control requirements associated with cell and gene therapies.
Next-generation sequencing allows researchers to analyze genetic material and detect potential viral contaminants, helping manufacturers assess product safety and meet regulatory requirements.
“As we prepare for the next stage of Zelestrocel’s development, having access to advanced testing technologies and collaborating with experienced partners is critical to our success,” said Julien Freitag, Chief Executive Officer of Magellan Stem Cells.
Magellan Chief Operating Officer Nick Bliesner said Charles River’s sequencing capabilities will help strengthen the company’s regulatory preparation as it moves toward potential commercialization.
“Charles River’s GMP NGS capabilities provide an innovative approach to viral safety testing that supports both product quality and regulatory readiness,” Bliesner said.
Charles River said its sequencing services are designed to meet regulatory standards established by the U.S. Food and Drug Administration, European Medicines Agency and international pharmaceutical quality organizations.
The technology also supports the company’s Alternative Methods Advancement Project, an initiative aimed at developing new scientific testing approaches that reduce reliance on animal studies.
Charles River has expanded its sequencing capabilities through the acquisition of Pathoquest, a company specializing in next-generation sequencing technologies for biopharmaceutical testing and quality control.
The company also provides cell banking, cell line characterization and manufacturing support services for biotechnology and pharmaceutical companies developing advanced therapies.
Charles River said the collaboration with Magellan reflects growing demand for specialized testing services as regenerative medicine and cell-based therapies move through clinical development toward potential commercialization.
