Cold Chain
A temperature-controlled supply chain maintaining products within a specified range (typically 2-8°C) from manufacture to use. Cold chain integrity is critical for most peptide drugs, as temperature excursions can cause degradation, potency loss, or formation of harmful degradation products.
Technical Context
Cold chain requirements for peptide drugs: storage (2-8°C for most refrigerated products, -20°C for some frozen products, room temperature ≤25°C for some stable formulations), shipping (validated insulated packaging with phase-change materials or active temperature control systems), monitoring (data loggers recording temperature throughout transit — min/max and continuous recording; excursion documentation), and handling (receiving procedures verifying temperature upon arrival, proper pharmacy/hospital storage, patient-level storage guidance). Cold chain failures can cause: peptide degradation (potency loss, increased impurities), aggregation (potentially immunogenic), physical changes (precipitates, colour change), and complete product loss. Some peptide products have room temperature stability windows (e.g. semaglutide pens can be stored at room temperature for up to 6 weeks after first use) — these convenience features are established through stability testing. Cold chain logistics significantly impact product distribution costs and global accessibility.