The American Cancer Society describes immunotherapy “as a treatment that uses your body’s own immune system to help fight cancer.” It cites monoclonal antibodies (mAbs), immune system checkpoint inhibitors and vaccines among the immunotherapy treatments now in development for a variety of cancers.
Recently, Novartis signed an agreement contracting Cryoport over an initial three-year term for cryogenic logistics support of its now commercialized CTL019/CD19 CAR-T cell therapy, an immunotherapy treatment.
Cryoport’s cryogenic logistics offerings are designed to meet Novartis’ expanding cryogenic logistics requirements, including the use of its Cryoport Express® shippers, SmartPak IITM Condition Monitoring System, Cryoportal™ Logistics Management Platform, which includes chain-of-condition, chain-of-custody monitoring and 24/7/365 logistics support.
On March 29th, 2017 Novartis announced that the FDA had accepted their first Biologics License Application for CTL019 and that it was also granted priority review by the FDA.
“We are limited in the number of patients we can treat given the cumbersome supply chain that we have going,” says Philip Gotwals, Chief of Exploratory Immune-Oncology at Novartis. “If we don’t do anything to automate the process, you would have to [build more of] these large factories, and I don’t know if the industry would do that.”
Jerrell Shelton, CEO of Cryoport, says, “We are proud that Novartis has chosen Cryoport to support the clinical studies and the commercialization of its CLT019. This is a milestone for Cryoport. We enjoy meeting Novartis’s exacting requirements and are delighted to have this commercial agreement in place.”