What Patients Need to Know about Pharmaceutical Supply Chains—Chapter 4
Everything a critcal thinker needs to know about the supply chains for SARS-CoV-2 injections—packed with facts and evidence that can't be refuted.
Managing temperature sensitive supply chains (cold-chain management)
Biologics and temperature
Drugs have always been sensitive to temperature variation, small molecule, or biologics. In practice, the major focus in the industry has been on biologics. This is because living things can only survive at temperatures nature intended them to survive at. There is great variation on what those temperatures are.
With the growth of biologics coming initially from monoclonal antibodies (eg Herceptin), the service providers competing in the industry have grown exponentially, as have the temperature ranges to be serviced.
The main temperature ranges for storage are:
Ambient: +15 to +30°C.
Controlled Room Temperature (CRT): +20 to +25 °C.
Refrigerated: +2 to +8 °C.
Freezer: -40 to -20 °C
Ultra-Low Freezer: -93 to -70 °C.
Cryogenic Freezer (LN2): -193 to -150 °C