Cryoport's Temperature Controlled Supply Chain Blog

Precision medicine requires end-to-end traceability: everything from chain of custody, to chain of condition, to chain of identity. But the fragility of regenerative medicine therapies – and the need to more effectively manage risk– means that a fourth chain will soon be a regulatory requirement: the Chain of Compliance®. Enhanced traceability within the temperature-controlled and cold chain logistics distribution will soon be subjected to additional regulatory requirements due to the fragile aspect of the drug product and the disproportionate risk of improper cold chain management on the viability of the therapies. 

In our new video, Cryoport Vice President of Quality Assurance and Regulatory Affairs, along with Cryoport Chief Commercial Officer Mark Sawicki, explain how we created and implemented Chain of Compliance ®.