Video Clips From Cell & Gene Live: Optimizing Your Cold Chain For Cell Therapies
By Erin Harris, Editor-In-Chief, Cell & Gene
Follow Me On Twitter @ErinHarris_1
Given the dramatic scientific developments in advanced medicines, development of technological advances in the cold chain have been relatively limited. Cryopreservation, storage, and shipment options remain much along the lines of those used decades ago. However, significant improvements have arrived for monitoring and recording shipment and storage, and equipment to facilitate continuity of temperature in the cold chain and reproducible thawing of cell-based medicines.
We dedicated a Cell & Gene Live to the topic of cold chain complexities. In case you missed it, Optimizing Your Cold Chain for Cell Therapies featured experts Ryan Crisman, Co-Founder and CTO at Umoja Biopharma and Rookie Gleich, Global Head, Cell Therapy Logistics and Shipping Systems at Bristol Myers Squibb (BMS). During the hour, our experts shared practical ways to improve shipping systems, tracking, product monitoring, and more for both just-in-time delivery and cryogenic preservation. You can view the entire presentation here. For your convenience and reference, we’ve broken down the presentation into bite-size video clips by topic. Enjoy!
An Inside Look At Umoja Biopharma And Bristol Myers Squibb's Cold Chains
In this segment, Umoja’s Co-Founder and CTO Ryan Crisman details The CLIMB, or The Colorado Laboratory & Innovative Manufacturing Building, and provides an overview of how an optimized cold chain is critical in the work being done at Umoja’s The CLIMB. Rookie Gleich, Global Head, Cell Therapy Logistics and Shipping Systems, BMS explains some of the challenges around cell therapy temperature standardization and why a wider temperature range may optimize the process.
Overcoming Cryopreservation Challenges
As commercial and clinical cellular therapy products become more mainstream, there has been a renewed focus on each step of the cryopreservation process and the reagents being used. Here, Umoja’s Co-Founder and CTO Ryan Crisman and BMS’ Global Head, Cell Therapy Logistics and Shipping Systems, Rookie Gleich share how they are tackling some of the biggest issues in cryopreservation as well as best practices given the complex structure of freezing and thawing systems.
Because each shipment is unique, cryogenic logistics strategies are needed to manage the critical temperature of cell therapies prior to shipment, during transit, and at the delivery site. In this segment, Umoja’s Co-Founder and CTO Ryan Crisman and BMS’ Global Head, Cell Therapy Logistics and Shipping Systems, Rookie Gleich explain some of the key risk management mitigation issues regarding managing temperature before, during, and after transit.
Regulatory Considerations For An Optimized Cold Chain
Here, Umoja’s Co-Founder and CTO Ryan Crisman and BMS’ Global Head, Cell Therapy Logistics and Shipping Systems, Rookie Gleich detail some of the regulatory requirements they’re up against and how they work with the FDA.
Inventory Management, Staff Training, And Timeline Optimization
Accurate inventory management, staff training, and timeline optimization are vital in ensuring products reach patients when needed and in a viable state. Here, Umoja’s Co-Founder and CTO Ryan Crisman and BMS' Global Head, Cell Therapy Logistics and Shipping Systems, Rookie Gleich explain the improvements that can be made in each of the following: inventory management, staff training, and timeline.
Couriers play an important role in the safeguarding process, while also ensuring handling requirements are adhered to en route and that contingency plans are in place to manage any unexpected incidents or delays. Here, Umoja’s Co-Founder and CTO Ryan Crisman and BMS’ Global Head, Cell Therapy Logistics and Shipping Systems, Rookie Gleich discuss the ways in which couriers might optimize their workflow, and when their teams look for when partnering with couriers.
Tracking shipment location and temperature are critical parameters part of the value stream of cell therapy. Here, Umoja’s Co-Founder and CTO Ryan Crisman and BMS’ Global Head, Cell Therapy Logistics and Shipping Systems, Rookie Gleich talk about whether temperature monitoring devices are really truly necessary when using a shipper that has been tested and validated to hold a specific temperature range for a specified period, and more.
Optimizing Your Cold Chain For Cell Therapies | Audience Questions
In this segment, Umoja’s Co-Founder and CTO, Ryan Crisman and BMS’ Global Head, Cell Therapy Logistics and Shipping Systems, Rookie Gleich answer questions from the audience, including the best way to de-risk contract couriers’ use of contract carriers for specialty shipments and more.