Charles River Laboratories International, Inc. and Magellan Stem Cells, a private Australian biotech and cell-therapy firm, have announced their collaboration to support Magellan in the development and clinical advancement of its proprietary stem cell-based therapies and regenerative medicine solutions.
The partnership will leverage Charles River’s specialised expertise in biologics quality control, current Good Manufacturing Practice (cGMP) viral and release testing, and extensive development support services.
By integrating Charles River's comprehensive testing and development solutions with Magellan’s advances in cell therapy development, manufacturing and clinical application, the collaboration aims to drive innovation and create shared value.
Charles River will provide viral safety testing using cGMP Next-Generation Sequencing (NGS) for Cell and Gene Therapy (CGT), supporting a high-quality therapy development process aligned with international regulatory standards.
Magellan recently concluded Phase I/II clinical trials of its lead proprietary allogeneic, off-the-shelf stem cell therapy candidate – Zelestrocel - for osteoarthritis and is preparing to launch its pivotal Phase III programme. Alongside this, Magellan has purposefully vertically integrated scalable manufacturing capability into its development pathway, having secured GMP certification from the Therapeutic Goods Administration (TGA) for its manufacturing facility in Melbourne, Australia (1 of only 4 GMP certified cell therapy manufacturing facilities in Australia).
