Charles River Laboratories International announced a collaboration with Arovella Therapeutics, 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.”