- Charles River Laboratories has partnered with Arovella Therapeutics to provide Good Manufacturing Practice (GMP) next-generation sequencing (NGS) services for cell characterization and viral safety testing.
- The collaboration supports the development and clinical manufacturing of Arovella’s off-the-shelf CAR-iNKT cell therapy candidate, ALA-101, for lymphoma and leukemia.
Charles River Laboratories International Inc. has entered into a collaboration with Arovella Therapeutics Ltd. to provide Good Manufacturing Practice (GMP) next-generation sequencing (NGS) services for cell characterization as part of Arovella’s cell therapy development program. The partnership is intended to support the development of Arovella’s invariant natural killer T (iNKT) cell therapy platform for the treatment of cancer.
Under the agreement, Charles River will provide NGS services for cell bank characterization and perform viral safety release testing on clinical batches of ALA-101, Arovella’s off-the-shelf CAR-iNKT cell therapy candidate for CD19-positive B-cell lymphomas and leukemias. The companies said the collaboration supports Arovella’s clinical manufacturing program and follows the U.S. Food and Drug Administration’s acceptance of NGS in the company’s investigational new drug (IND) application.
“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 SVP, Global Manufacturing, Charles River
Charles River said the collaboration reflects its focus on providing analytical and testing services that support the development of cell and gene therapies. Arovella stated that integrating GMP-ready NGS and validated viral safety testing into its manufacturing program is intended to strengthen safety, quality, and regulatory compliance for ALA-101.
The agreement expands Charles River’s role in supporting advanced therapy developers with analytical services for clinical manufacturing and complements Arovella’s efforts to advance its CAR-iNKT therapy toward clinical development.
