Wilmington, Mass. — Charles River Laboratories will provide Good Manufacturing Practice next-generation sequencing services to Arovella Therapeutics to support development of the biotechnology company’s experimental cancer cell therapy platform.
The collaboration will include cell bank characterization and viral safety testing for ALA-101, Arovella’s off-the-shelf CAR-iNKT cell therapy being developed for CD19-positive B-cell lymphomas and leukemias.
Charles River said the FDA accepted the use of next-generation sequencing for viral safety testing of two cell banks that produce reagents used in the ALA-101 manufacturing process. The company will also conduct viral safety release testing on clinical batches of the therapy.
“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.”
ALA-101 uses invariant natural killer T cells engineered with a chimeric antigen receptor targeting CD19. The allogeneic treatment is designed to be manufactured from healthy donor cells and administered to patients.
“We are thrilled to collaborate with Charles River Laboratories to strengthen the foundation of our clinical manufacturing program,” said Dr. Nicole van der Weerden, Chief Executive Officer 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.”
Charles River said its GMP sequencing services are designed to support genetic analysis, pathogen detection and regulatory testing during the development of advanced therapies. The company recently expanded those capabilities through its acquisition of Pathoquest, a provider of next-generation sequencing services for biopharmaceutical quality-control testing.
Arovella is also developing therapies for solid tumors using CLDN18.2-targeting and IL-12-TM technologies.
