July 20, 2018, the FDA published this document:
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)…Draft Guidance for Industry
We finally finished reading the whole thing and wanted to bring your attention to Module 2 (Summary of Quality Information), Section D (Product Handling At The Clinical Site). Please read the following excerpt from that document and, if you are uncertain how to comply, then call us (or stop by to see us at the upcoming shows in Boston and London).
Our evo system (evo hardware + evo.is) currently supports the guidance advise relating to shipping condtions, storage conditions expiration date/time, chain of custody, and handling at the clinical site to the bedside.
We are proud to have lead the way in the awareness of these needs and to have developed a solution for these needs. Our system is IND ready!