Charles River, Magellan Partner to Advance Stem Cell, Regenerative Medicine Solutions

Editor’s Take: Such collaborations drive innovation and create shared value by integrating comprehensive testing and development capabilities.

Charles River Laboratories will support Magellan Stem Cells in the latter’s development and clinical advancement of proprietary stem cell-based therapies. The companies’ new agreement also covers Magellan’s regenerative medicine solutions.

What Charles River will bring to the partnership, primarily, is specialized expertise in biologics quality control. Charles River also has experience in current good manufacturing practice (cGMP) viral and release testing, plus development support services.

To be more precise, Charles River’s viral safety testing uses cGMP next-generation sequencing (NGS) for cell and gene therapy (CGT). This supports a high-quality therapy development process that aligns with international regulatory standards.

Magellan Advancing Candidate to Phase III

Crucially, Magellan has just completed Phase I/II trials of its lead proprietary allogeneic, off-the-shelf stem cell therapy candidate. Called Zelestrocel, this is being tested as a treatment for osteoarthritis, and is about to be launched in Phase III.

The two companies hope to combine Charles River’s comprehensive testing and development capabilities with Magellan’s various advances. Among these are not only cell therapy development, but also manufacturing and clinical application.

Charles River Helping Create Value

“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.”

Kerstin Dolph, Corporate SVP, Charles River Labs

In so doing, Charles River and Magellan say, they will drive innovation and create shared value.

Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River, hammered home that point.

“Working with organizations at the forefront of innovation allows us to expand our GMP testing capabilities,” Dolph said. “We are excited to support Magellan as they work toward advancing Zelestrocel from the clinic to potential commercialization.”

“Charles River’s GMP NGS capabilities provide an innovative approach to viral safety testing,” Magellan Chief Operating Officer Nick Bliesner said. “This collaboration strengthens our ability to advance Zelestrocel toward commercialization with confidence.”