Modality Solutions White Paper:
The Challenges of Cold Chain Validation for Regenerative Medicine

The Challenges of Cold Chain Validation for Regenerative Medicine

Regenerative medicine is a novel biomolecular approach to exciting new clinical therapies. Generally, this grouping involves three major therapy applications: cell therapies or stem cell injections; immunotherapy, and tissue engineering. Existing supply chains were never intended to effectively manage an elevated risk profile for a drug that targets a single patient.

Learn how the cold chain validation landscape for regenerative medicines is rapidly changing because:

Regulatory requirements are changing. While temperature maintenance is one of the critical elements for shipping, these results alone are insufficient to support shipping validation.

Understand your damage boundaries. Testing at the damage boundaries is the only way to confirm your drug product quality is not compromised during transport.
Test in your operating space. Concurrent, multivariate simulation testing is the only way to confirm drug product quality at the edges of your operating space.
Vary your approach by therapy. Regulatory success depends on matching your validation approach to your specific therapy.
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