Charles River Laboratories has entered a collaboration with Arovella Therapeutics to provide Good Manufacturing Practice (GMP) next-generation sequencing (NGS) services and viral safety testing to support development of Arovella’s investigational CAR-iNKT cell therapy for lymphoma and leukemia.

Under the agreement, Charles River will provide NGS-based cell bank characterization and viral safety release testing for clinical batches of ALA-101, an off-the-shelf CAR-invariant natural killer T (CAR-iNKT) cell therapy being developed to treat CD19-positive B-cell lymphomas and leukemias.

According to the companies, the U.S. Food and Drug Administration (FDA) accepted the use of NGS for viral safety testing of two cell banks supporting the ALA-101 manufacturing process as part of Arovella’s investigational new drug (IND) application.

Charles River said its GMP-compliant NGS services are designed to support cell and gene therapy developers by providing sequencing-based characterization and viral safety testing that aligns with regulatory requirements, including FDA, European Medicines Agency and International Council for Harmonization guidelines.

“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,” Kerstin Dolph, corporate senior vice president, global manufacturing at Charles River, said in a statement.

Charles River also noted that its recent acquisition of Pathoquest expands its NGS capabilities for in vitro characterization and quality control testing of biopharmaceutical products.

The announcement follows other recent changes at Charles River. In February, the company announced an agreement to divest its CDMO and cell solutions businesses to private investment firm GI Partners. The transaction includes CDMO facilities in Tennessee, Maryland, and the United Kingdom — along with a cell solutions site in California — as Charles River refocuses its portfolio on businesses it contends are more closely aligned with the company’s long-term growth strategy.