Charles River to provide NGS services for Arovella cancer therapy
Charles River Laboratories International (NYSE: CRL) announced a collaboration with Arovella Therapeutics to provide Good Manufacturing Practice Next Generation Sequencing (NGS) services for cell characterization in support of Arovella's cancer cell therapy program.
Under the agreement, Charles River will provide GMP 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 targeting CD19+ B cell lymphomas and leukemias.
The FDA accepted the use of NGS for viral safety testing of two cell banks that produce reagents used in the ALA-101 manufacturing process as part of a successful Investigational New Drug application.
"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," said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River.
Dr. Nicole van der Weerden, CEO of Arovella Therapeutics, said the collaboration is intended to strengthen the company's clinical manufacturing program by integrating advanced sequencing for cell bank characterization alongside validated viral safety testing for clinical batch release.
Charles River recently acquired Pathoquest, a company focused on NGS solutions for in vitro characterization and quality control testing of biopharmaceutical products, according to the press release.
