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Partnership with Dacos A/S; FDA will look closer at cellular and genetic therapies
Cryoport, one of a handful of companies that provides containers and logistics solutions for deep-frozen or cryogenic storage and conveyance of life sciences materials (it also does more conventional refrigerated containers) has announced a partnership with a Danish firm, Dacos A/S, to provide the full suite of Cryoport offerings. These include Cryoport Express shippers, the Cryoportal Logistics Management Platform, Smartpak II Condition Monitoring System and 24/7/365 logistics support.
Dacos is global supplier of advanced laboratory materials, including vials, storage boxes, shipping containers and PET bottles for serum and media. According to Mark Sawicki, chief commercial officer at Cryoport, Dacos will now be able to refer its customers to Cryoport when those filled containers need to be transported from one location to another. Cryoport operates globally, and in the case of Europe, has opened a logistics center in the Netherlands to handle shipments transiting through the Continent.
Over the past several months, Cryoport has taken several steps to deepen its suite of services to life sciences (it also operates in animal health and reproductive health markets). In October, it opened its third logistics center in Livingston, NJ (the other site, besides the Netherlands, is its Irvine, CA HQ; additionally, there is also a partnered center in Singapore). That same month, it signed an agreement with BeTheMatch, an organization that, among other things, operates the US National Bone Marrow Donation Program, which has been matching transplant donors with patients for decades. BeTheMatch has developed an IT system, MatchSource, which manages operations and workflows from apheresis centers (where stem cells in bone marrow are collected) to therapy sites. This software will integrate with Cryoport’s CryoPortal. “The outcome is a platform that manages more cell therapy products than any other solution in the marketplace, enabling cell and gene therapy [CGT] companies to more rapidly discover, develop and deliver next-generation therapies,” says the company.
Along the way, Cryoport has begun to promote a new concept in CGT logistics: the (branded) Chain of Compliance. “Industry has recognized, and FDA is beginning to focus on, the need to standardize logistics operations in CGT therapies,” says Sawicki; in effect, CGT logistics needs the same level of management of equipment and processes as GMP standards in manufacturing. Chain of Compliance is a way to manage and document every step in the logistics process, including containers with serial tags, environmental conditions during shipments, carriers and the rest, all in an auditable traceability system, he says.
Just this week (and with much of FDA shut down), FDA Commissioner Scott Gottlieb issued a statement on next steps the agency is taking in CGT. "We anticipate that by 2020 we will be receiving more than 200 INDs [Investigational New Drug applications] per year, building upon our total of more than 800 active cell-based or directly administered gene therapy INDs currently on file with the FDA," he wrote. "And by 2025, we predict that the FDA will be approving 10 to 20 cell and gene therapy products a year based on an assessment of the current pipeline and the clinical success rates of these products." In anticipation, FDA will be updating its processes for reviewing both clinical and manufacturing processes for the therapies.