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.