Charles River Laboratories International (CRL) has collaborated with Australian biotechnology firm Magellan Stem Cells to advance the development and clinical progress of Magellan's regenerative medicine candidate, Zelestrocel.
The partnership focuses on biologics quality control as well as viral and release testing under current good manufacturing practice (cGMP) standards.
Magellan recently completed Phase I/II clinical studies evaluating Zelestrocel, an off-the-shelf, allogeneic stem cell therapy designed to treat osteoarthritis.
The company is now preparing to initiate a pivotal Phase III clinical programme.
Charles River global manufacturing corporate senior vice president Kerstin Dolph said: “Working with organisations at the forefront of innovation allows us to expand our GMP testing capabilities and help accelerate the delivery of safe, compliant therapies to patients.
“We are excited to support Magellan as they work towards advancing Zelestrocel from the clinic to potential commercialisation.”
To support the therapy’s progress towards international regulatory standards, Charles River will provide viral safety assessments using next-generation sequencing (NGS) for cell and gene therapy (CGT).
The testing protocols comply with regulatory benchmarks from the European Medicines Agency (EMA), the Food and Drug Administration (FDA), GMP standards, and International Council for Harmonisation (ICH) Q5A and Q5B guidelines.
Charles River expanded its sequencing capabilities through the acquisition of Pathoquest, a company specialising in biopharmaceutical quality control and characterisation.
Magellan COO Nick Bliesner said: “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 commercialisation with confidence.”
Magellan manufactures the cell therapy internally at its Melbourne facility, which holds GMP certification from the Therapeutic Goods Administration (TGA).
It is one of only four cell therapy manufacturing centres in Australia to hold GMP certification.
The sequencing work also aligns with Charles River’s Alternative Methods Advancement Project (AMAP), an initiative guided by a scientific advisory board chaired by Dr Namandjé Bumpus to reduce animal testing by implementing new approach methodologies (NAMs).
In addition, Charles River operates nine CGMP-compliant International Organization for Standardization-6 (ISO-6) cleanroom suites, offers cell bank release within eight to ten weeks, and has produced more than 2,000 cell and viral banks.
In August this year, CRL and Medigen Vaccine Biologics (MVC) entered into a collaboration to support the characterisation and validation of the virus seed bank for MVC’s next-generation multivalent enterovirus vaccine.
