Collaboration aligns with Charles River’s strategic commitment to building deeper client relationships and accelerating development with alternative methods
WILMINGTON, Mass.--(BUSINESS WIRE)--$CRL #CDMO--Charles River Laboratories International, Inc. (NYSE: CRL) today announced a collaboration with Arovella Therapeutics Ltd (ASX: ALA), a biotechnology company, to provide Good Manufacturing Practice (GMP) Next Generation Sequencing (NGS) services for cell characterization. The collaboration helps Arovella achieve its goal of creating a unique Invariant Natural Killer T (iNKT) cell therapy platform for cancer treatment. In a successful IND application, the FDA approved the use of NGS for viral safety testing of two cell banks that produce reagents used in the ALA-101 manufacturing process.
“Providing Arovella with NGS services as they advance a transformative iNKT cell therapy platform for patients with lymphoma and leukemia closely aligns with our strategic goal to deliver enhanced client experiences,” said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River. “The FDA’s acceptance of NGS in Arovella’s IND underscores the value of modern, GMP‑ready sequencing to enable safer, more efficient development of cell and gene therapies, and our commitment to advancing science through our world-class portfolio.”
In addition to NGS services for cell bank characterization, Charles River will perform viral safety release testing on clinical batches of ALA-101. This next-generation, off-the-shelf CAR-iNKT cell therapy aims to treat CD19+ B cell lymphomas and leukemias.
“We are thrilled to collaborate with Charles River Laboratories to strengthen the foundation of our clinical manufacturing program,” said Dr. Nicole van der Weerden, CEO of Arovella Therapeutics. “By integrating advanced next-generation sequencing for comprehensive cell bank characterization and using a suite of validated viral safety tests for the release of clinical batches, we are reinforcing our commitment to the highest standards of safety, quality, and regulatory rigor and ensuring patients receive therapies backed by the most robust and innovative analytical approaches available.”
Next Generation Sequencing
NGS is revolutionizing the way advanced therapeutics are characterized and tested, including in vitro applications, ensuring high-quality products are delivered to patients. NGS has transformed the genetic analysis and pathogen detection landscape 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 recently 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 weeks 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 Arovella Therapeutics
Arovella Therapeutics Ltd (ASX: ALA) is a biotechnology company focused on developing its invariant natural killer T (iNKT) cell therapy platform from Imperial College London to treat blood cancers and solid tumours. Arovella’s lead product is ALA-101. ALA-101 consists of CAR19-iNKT cells that have been modified to produce a Chimeric Antigen Receptor (CAR) that targets CD19. CD19 is an antigen found on the surface of numerous cancer types. iNKT cells also contain an invariant T cell receptor (iTCR) that targets glycolipid bound CD1d, another antigen found on the surface of several cancer types. ALA-101 has had its IND accepted by the US FDA and is being developed as an allogeneic cell therapy, which means it can be given from a healthy donor to a patient. Arovella is also expanding into solid tumour treatment through its CLDN18.2-targeting technology licensed from Sparx Group. Arovella will also incorporate its IL-12-TM technology into its solid tumour programs.
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.
Contacts
Charles River Investor Contact:
Todd Spencer
Corporate Vice President,
Investor Relations
781.222.6455
todd.spencer@crl.com
Charles River Media Contact:
Amy Cianciaruso
Corporate Vice President,
Chief Communications Officer
781.222.6168
amy.cianciaruso@crl.com
