On July 13, 2026 Charles River Laboratories International, Inc. (NYSE: CRL) reported 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.
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"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.
(Press release, Charles River Laboratories, JUL 13, 2026, View Source [SID1234669178])