When considering your temperature-controlled logistics needs, it is important to think about the compliance consideration steps in the drug development and delivery process being more than just getting biologic material from point A to point B. You need to keep in mind that your distribution needs are just one more integrated step in your business process flow. In addition, there are a large number of regulations and standards to consider regarding quality and document control, equipment validation, facilities, and personnel—just to name a few.
The implementation and deployment of enterprise systems provides a platform that gives users visibility and control into the health of the business. The need for visibility does not stop with IT systems (HR, Finance, Business Development, etc). It is critically important to have a Chain of Compliance™ surrounding your distribution and delivery platforms. More than just location monitoring, you need to be informed about temperature, humidity, light exposure, vibration, exposure to non-human commodities as well as other data points used to inform you about the state of the material being transported.
We know that biology is continuing to advance, just consider the 2017 FDA approvals of cellular and genetic therapies like Kymriah™ (Novartis) and Yescarta™ (Gilead). These are the first of what is to be expected and increasing number of therapies approved in the coming years. At Cryoport, we believe the FDA, as well as other regulatory bodies, will be taking an ever-increasing look at the requirements surrounding cold chain logistics. Couple that with advances in future clinical development will only add to the need for a Chain of Compliance™ surrounding temperature-controlled logistics needs.
Written by: Ryan Carpentier, Sr. Director, Business Development, Cryoport
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