Bothell-based BioLife Solutions, Inc. today announced that its clinical grade CryoStor freeze media has been incorporated into the manufacturing process for Invossa, a cell-mediated gene therapy for knee osteoarthritis to be marketed by Kolon Life Science.
The Kolon Group subsidiary filed as of July 8 a biologics license application (BLA) for Invossa with the Korean Ministry of Food and Drug Safety. According to Kolon, Invossa is the world’s first cell-mediated gene therapy for osteoarthritis, a degenerative joint disease affecting more than 150 million people. The product was developed by US-based TissueGene, Inc. as “TissueGene-C” and is administered via intra-articular injection without the need for anesthesia or surgical intervention. The therapy has demonstrated effectiveness in providing pain and symptomatic relief as well as in delaying the disease’s structural progression.
“Kolon’s BLA submission seeking approval to market Invossa in Korea is encouraging news for millions of patients suffering from osteoarthritis,” said BioLife President and CEO Mike Rice. “We are very pleased that TissueGene and Kolon have selected CryoStor as the best in class biopreservation media for commercializing Invossa. CryoStor and HypoThermosol®, our cell and tissue storage and shipping media, are now incorporated into more than 220 pre-clinical validations and clinical trials of cell-based therapies, targeting blood cancers, solid tumors, vision loss, heart disease, stroke, and movement disorders such as osteoarthritis. We look forward to progress by Kolon and other customers in gaining regulatory approvals to commence commercial manufacturing of these life-changing and life-saving cell therapies.”