Collaboration leverages next-generation sequencing (NGS) services to advance development and commercialization of an off-the-shelf therapy for osteoarthritis and future programs
WILMINGTON, Mass.--BUSINESS WIRE--
Charles River Laboratories International, Inc. (NYSE: CRL) and Magellan Stem Cells, a private Australian biotech and cell-therapy firm, announce 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 specialized 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.
“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, Global Manufacturing, Charles River. “We are excited to support Magellan as they work towards advancing Zelestrocel from the clinic to potential commercialization.”
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. Charles River’s NGS service offering highlights the Company's commitment to the 3Rs (Replacement, Reduction, Refinement) through its Alternative Methods Advancement Project™ (AMAP™), which develops and implements New Approach Methodologies (NAMs) and other innovative strategies to reduce reliance on animal testing while supporting efficient product development.
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 program. 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).
"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 Magellan Stem Cells CEO Assoc. Professor Julien Freitag.
Magellan’s COO Nick Bliesner highlights that "Charles River's GMP NGS capabilities provide an innovative approach to viral safety testing that supports both product quality and regulatory readiness. This collaboration strengthens our ability to advance Zelestrocel toward commercialization with confidence."
Modernizing Biologics Testing with NGS
NGS is revolutionizing the way advanced therapeutics are characterized and tested, ensuring high-quality products are delivered to patients. NGS has transformed the landscape of genetic analysis and pathogen detection with its high throughput, scalability, and speed.
Charles River’s cGMP NGS testing services accelerate development timelines without compromising safety and meets regulatory requirements for accuracy, reliability, and compliance with GMP, FDA, EMA, and ICH Q5A and Q5B.
To further enhance NGS capabilities, Charles River has acquired Pathoquest, a leader in NGS solutions for in vitro characterization and quality control testing of biopharmaceutical products. The acquisition enables Charles River to deliver even faster and more advanced sequencing-based testing to clients across the development pipeline.
Biologics Testing Solutions
Backed by decades of cell banking and cell line characterization expertise, Charles River’s full range of CGMP-compliant cell bank production and storage services include 9 CGMP-compliant ISO-6 cleanroom suites, 8-10 week cell bank completion to release, and over 2,000 cell and viral banks produced supporting client programs from research and development through commercial manufacturing.
About the Alternative Methods Advancement Project (AMAP)
The Alternative Methods Advancement Project (AMAP) is a Charles River-led initiative dedicated to developing New Approach Methodologies (NAMs) and exploring innovative scientific and technological solutions aimed at reducing reliance on traditional animal testing. As we enter the next frontier of drug development, AMAP enables strategic, purpose-driven investment to shape a future in which more patients can access the treatments and medicines they need safely, swiftly, and successfully. AMAP is supported by our global, cross-functional Scientific Advisory Board led by Dr. Namandjé N. Bumpus.
About Magellan Stem Cells
Magellan Stem Cells aims to develop innovative cell therapies with the capability of addressing unmet clinical needs, leading to significant community impact/benefit. Magellan’s leading proprietary cell therapy - Zelestrocel – is a defined allogeneic (donor) stem cell therapy for the treatment of osteoarthritis (OA). Magellan is founded on innovative research and development and clinical application, supported by a vertically integrated and scalable commercial manufacturing platform which provides the opportunity to address the unmet clinical need of OA (which affects >500million people globally). Visit: magellanstemcells.com.au
About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.
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