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, regeneration by biologically active molecules administered alone or as secretions by infused cells; and tissue engineering, transplantation of laboratory-grown organs and tissues.

The combination of the severity of the illness and limited availability of autologous blood supply from the patient creates an elevated risk profile. Existing supply chains were never intended to effectively manage risk for a drug that targets only one single patient.

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Case Study: Immunomedics

Immunomedics (www.immunomedics.com) is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment...