Case Study: Using Robust Cold Chain Validation Data to Support Filing for CAR-T Therapy


Atara was seeking to identify and implement a revised frozen logistics process to transport palletized clinical trial material as ‘turnkey’ solution. The previous transportation mode and deep frozen conditions had been identified as a potential cause for broken vial incidents. After providing a frozen shipping solution, Atara wanted a refrigerated liquid formulation.


  • Design and implement triage shipping plan for frozen product.
  • Qualify packaging and create training documentation for CMO.
  • Writing technical report on results for the formulation change.


  • Triage plan successful with no incidents of temperature excursions or broken vials
  • Selected and implemented packaging, process and monitoring technology and trained personnel
  • Profile developed and testing conducted for change from frozen to liquid drug formulation