Moving and storing clinical trial therapeutics — such as immunotherapies or regenerative medicines — and biospecimens across the globe are especially complex operations because the materials cannot experience temperature excursions. While frozen materials are shipped and received every day, the logistics and storage of these temperature sensitive materials create new challenges for even the largest and most experienced clinical trial networks and supply chain managers.
With logistics, complete chain-of-custody and chain-of-condition information is critical to ensure the integrity of products during shipment. Linking chain of custody events to their impact on the chain of condition is increasing in importance. However, bio-storage and fulfillment capabilities are playing an increasingly more important role in maintaining product quality while accommodating shipping timelines and workflow management for sponsors, investigators and researchers.
Obtaining bio-storage services is the next logical step for load balancing supply chains. However, there are specific controls and safety measures that companies need to address in order to mitigate risk when considering bio-storage, whether storing in-house or outsourcing to a partner. Additionally, during clinical planning, there are other decisions that need to be made to protect product quality and provide a validated documented process.
Some of the issues that must be addressed include:
- Decisions to store on site; lease vs. buy
- Decisions to store remotely; choosing the right partner
- Temporary vs. long-term storage
- Capacity planning; from a single sample to larger inventory requirements
Designing robust, validated processes and controls:
- cGMP compliant storage
- Security: controlled access to samples
- Environmental controls
- 21 CFR Part 11 compliant monitoring
Mitigating risk with adequate controls:
- 24/7/365 alarm response, redundant freezers, back-up power
- Equipment management: planned maintenance and calibration scheduling in compliance with manufacturer's specifications
- Inventory tracking and sample management
- Audit ready
Obtaining the data needed for reporting requirements and audits:
- Frequency of reporting
- Inventory activity
- Access activity
Cryoport combines detailed logistics, bio-storage and fulfillment capabilities to create complete control and transparency regarding the access and conditions of materials. Cryoport’s team of experts can assist companies in planning for an end-to-end solution and compliant workflows that protect materials and patients while providing the information to validate clinical trial data. To learn more, contact us today.