By Rachel Sanders
In multi-site clinical trials, cell preservation and transportation is a significant bottleneck. Coordinating shipments across multiple locations, maintaining cell viability and managing costs can be a daunting task. Atelerix's innovative ambient temperature cell shipping technology offers a game-changing solution, streamlining collaboration and enhancing the efficiency of clinical trials.
The Traditional Challenges of Multi-Site Clinical Trials
Before delving into the benefits of ambient temperature shipping, let's examine the typical hurdles faced in multi-site trials:
- Maintaining Cell Viability: Cryopreservation can reduce cell viability by up to 50% post-thaw, potentially compromising trial results.
- Logistics: Coordinating cryogenic shipments requires specialised equipment and precise timing.
- Cost Implications: Cryogenic shipping is expensive, especially for international trials.
- Scheduling Constraints: The narrow window for cell use post-thaw complicates patient treatment schedules.
The Atelerix Solution: Ambient Temperature Cell Shipping
Atelerix's hydrogel encapsulation allows for the storage and transport of cells between 4°C and 25°C, addressing these challenges head-on.
- Enhanced Cell Viability: Cells maintain >90% viability for 7 days at room temperature. Cryopreserved cells often show reduced viability (70-80%) and potential functional changes post-thawing.
- Simplified Logistics: Standard packaging and regular courier services streamline shipping in comparison to the specialised cryogenic shipping containers and hazardous dry ice required for cryogenic transport.
- Reduced Costs: Potential savings of 50-80% per shipment as no special packaging or expedited services required.
- Flexible Scheduling: Cells remain viable for days rather than hours, easing the demands of scheduling patient treatments.
Impacts:
- Higher cell viability translates to more consistent trial results.
- Easier coordination of shipments across multiple trial sites, reducing the risk of delays and simplifying international collaborations.
- Lower operational costs for multi-site trials, allowing for broader geographical reach or increased sample sizes within the same budget.
- Easier coordination of patient treatments across different time zones and sites, reducing the risk of wasted samples due to scheduling conflicts.
Case Study: Streamlining a Multi-Site CAR-T Cell Therapy Trial
Let's consider a hypothetical Phase III clinical trial for a CAR-T cell therapy, involving 35 sites across Europe:
Traditional Workflow:
- T cells harvested at each site and cryopreserved.
- Frozen samples shipped to a central manufacturing facility.
- Manufactured CAR-T cells cryopreserved and shipped back to trial sites.
- Cells thawed and administered within a strict timeframe.
Challenges:
- Complex and expensive logistics coordinating at least 70 cryogenic shipments (35 to and 35 from the manufacturing site).
- High risk of delays or temperature excursions during transport.
- Inflexible patient treatment schedules due to short post-thaw viability window.
Atelerix Workflow:
- T cells harvested and immediately encapsulated in Atelerix hydrogel at each site.
- Samples shipped at ambient temperature to the manufacturing facility.
- Manufactured CAR-T cells encapsulated and shipped back to trial sites at room temperature.
- Cells de-encapsulated and administered within a flexible timeframe.
Benefits:
- Simplified logistics with standard shipping methods.
- Reduced risk of transport-related issues.
- Flexible scheduling for patient treatments.
- Potential for significant cost savings on shipping and handling.
Real-world Impact: A recent study demonstrated that CAR-T cells preserved using hydrogel encapsulation maintained >95% viability after 72 hours at room temperature, with no significant loss of cytotoxic function. This extended viability window could dramatically simplify the logistics of multi-site CAR-T trials.
Regulatory Considerations
Regulatory bodies, including the FDA, are supporting novel cell preservation methods like Atelerix’s ambient temperatre cell shipping, paving the way for broader adoption, in recognition of the need for new and innovative preservation methods.
The Future of Multi-Site Clinical Trials
As cell therapies become increasingly complex and globalised, the need for efficient, reliable transportation methods grows. Atelerix’s technology not only addresses the current challenges but also opens doors for greater collaborations worldwide.
Conclusion
By simplifying logistics, reducing costs, and maintaining cell viability, Atelerix’s ambient temperature shipping technology offers an innovative solution to a worldwide bottleneck issues in cell therapy development. This allows scientists to focus on what truly matters – advancing groundbreaking therapies and improving patient outcomes.
Why not try it for yourself?
Are you ready to revolutionise your multi-site clinical trial logistics? Atelerix offers tailored ambient temperature shipping solutions for a wide range of cell types and clinical applications. Contact us today to request a demonstration kit or schedule a consultation with our expert team. Discover how our hydrogel encapsulation technology can streamline your clinical trial workflows and enhance collaboration across sites.
Get your products here or book a consultation to find out more
References:
Atelerix. (n.d.). Fresh Sample Shelf Life AMPLIFIED! Retrieved from https://www.atelerix.co.uk
Internal Atelerix data (2023).
Jones et al. (2023). Nature Biotechnology, 41(6), 789-797.
FDA. (2022). Guidance for Industry: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.
