Definition: Specialized cold chain requirements for Advanced Therapy Medicinal Products including gene therapies, cell therapies, and tissue-engineered products. These products often require cryogenic temperatures and have unique handling requirements.
Why It Matters: ATMPs represent the frontier of pharmaceutical development. South Africa’s growing biotech sector and clinical trial activity creates demand for ATMP cold chain capabilities. Highly specialized, high-value logistics opportunity.
Temperature Requirements:
– Cell therapies: Often -150°C to -196°C (liquid nitrogen)
– Gene therapies: Varies by product (-80°C to -196°C common)
– Some products: Ultra-cold (-70°C to -80°C)
– Autologous products: Patient-specific, chain of identity critical
Special Requirements:
– Cryogenic shipping containers
– Continuous temperature monitoring
– Time-critical logistics (limited viability)
– Chain of identity (patient-specific products)
– Validated thawing procedures
– Specialized training
Related Terms: Cryogenic, Cell Therapy, Gene Therapy, GDP, Ultra-Cold Chain