Charles River Laboratories International, Inc. (NYSE: CRL) and Magellan Stem Cells have announced a collaboration to advance stem cell therapy and regenerative medicine development. The partnership brings together Charles River’s expertise in biologics quality control and specialized testing services with Magellan’s cell therapy development capabilities.
Magellan Stem Cells is a private Australian biotechnology and cell therapy company. Through this collaboration, Charles River will support the development and clinical advancement of Magellan’s proprietary stem cell-based therapies. Furthermore, the partnership will combine advanced testing solutions with manufacturing and clinical application expertise. Both companies aim to accelerate innovation and create shared value in regenerative medicine.
“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 Supports Advanced Stem Cell Therapy Testing
Charles River will provide viral safety testing through its current Good Manufacturing Practice (cGMP) Next-Generation Sequencing (NGS) services. These services support cell and gene therapy (CGT) development while helping companies meet international regulatory standards. Moreover, Charles River’s NGS testing capabilities support quality control throughout the therapy development process. The company also promotes the 3Rs principles: Replacement, Reduction, and Refinement.
Charles River is implementing its Alternative Methods Advancement Project™ (AMAP™), which focusses on New Approach Methodologies (NAMs). These strategies are aimed at minimising utilisation of animal testing in product development. Henceforth, the company concludes to innovate alternative testing methods relating to the pharmaceutical and biotechnology industries.
Magellan Prepares Zelestrocel for Phase III Clinical Trials
Magellan recently completed Phase I/II clinical trials for Zelestrocel, its proprietary allogeneic, off-the-shelf stem cell therapy candidate. The company is developing this treatment for osteoarthritis and is preparing to launch its pivotal Phase III program. Meanwhile, Magellan has integrated scalable manufacturing capabilities into its development strategy. This approach supports the company’s efforts to prepare Zelestrocel for further clinical development and potential commercialization.
Magellan has also secured Good Manufacturing Practice (GMP) certification from the Therapeutic Goods Administration (TGA). The certification covers its manufacturing facility in Melbourne, Australia. According to the announcement, the facility is one of only four GMP-certified cell therapy manufacturing facilities in Australia.
As Zelestrocel progresses toward its next development stage, advanced testing and manufacturing capabilities remain important priorities. Therefore, the partnership provides Magellan with access to specialized viral safety testing and quality control expertise.
“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.”
Modernization of Biologics Testing with Next Generation Sequencing
Next-Generation Sequencing is revolutionizing how researchers characterize and test advanced therapeutics. The technology enables companies to assess product quality and plays a role in developing safe treatments for patients. In addition, NGS is changing the game in pathogen detection and genetic analysis due to its high throughput, scalability and speed. These capabilities make it useful for biopharmaceutical testing and for the development of advanced therapies.
Charles River’s cGMP NGS testing services help to accelerate development timelines without compromising safety. The services also are compliant, accurate and reliable to regulatory expectations. Charles River also supports testing requirements associated with GMP, U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH Q5A and Q5B guidelines.
Charles River bought Pathoquest to bolster its sequencing capabilities. The company provides NGS solutions for in-vitro characterization and quality control testing of biopharmaceuticals. The acquisition therefore increases Charles River’s capacity to offer advanced sequencing-based testing. It also helps clients navigate the different phases of the product development pipeline.
Biologics Testing Solutions for Pharmaceutical Development
Charles River brings decades of experience in cell banking and cell line characterization. Its biologics testing solutions cover cell bank production, storage, and related quality control requirements. The company offers cGMP-compliant cell bank production and storage services. Its facilities include nine cGMP-compliant ISO-6 cleanroom suites. These facilities support controlled manufacturing environments for cell banking activities.
In addition, Charles River reports timelines of 8 to 10 weeks for cell bank completion and release. The company has made more than 2,000 cell and viral banks for client programs. They support pharmaceutical and biotechnology companies from research and development through to commercial manufacturing. Thus, clients enjoy dedicated test and manufacturing support at different stages of development.
Accelerating Regenerative Medicine and Cell Therapy Development
The partnership highlights the necessity of reliable testing, manufacturing readiness, and regulatory compliance for regenerative medicine. During clinical development of advanced therapies, companies need reliable methods for assessing product quality and viral safety. Magellan will leverage Charles River’s testing expertise to support continued development of Zelestrocel. Charles River will also utilize its cGMP testing capabilities for an emerging cell therapy program.
The companies will work together to improve the development process for stem cell therapy and regenerative medicine solutions. Their partnership offers specialty biologics testing, and expertise in cell therapy manufacturing and clinical development. The partnership also supports testing and regulatory readiness as Magellan prepares for the next clinical stage of Zelestrocel. Both companies aim to forge ahead with innovative therapies, but will keep quality and safety standards front and center of development.
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News Source: Businesswire.com
