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The SARS-CoV-2 injections require cold chain logistics—not something to be taken lightly

The SARS-CoV-2 injections require cold chain logistics—not something to be taken lightly

Shipping of temperature sensitive biologic products

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Hedley Rees
Sep 29, 2022
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INSIDE PHARMA
INSIDE PHARMA
The SARS-CoV-2 injections require cold chain logistics—not something to be taken lightly
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Biologics and temperature sensitivity

As we should all know by now, gene therapy products are in the class of ‘biologics’. That means they are manufactured from living things, human, animal, plant, or anything else living and sensitive to temperature variation.

All drugs are sensitive to temperature variation, and the impact of environmental factors. In practice though, the major focus has been on biologics. This is because living things can only survive at temperatures nature intended them to survive at. There is great variation in 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, and so have the temperature ranges to be serviced.

Examples of biologics products and materials today are antigens, antibodies, sera, plasma, plasmids, albumin/globulin, cytokines, hormones, cell-lines, blood, human tissue, and vaccines.

The main temperature ranges for storage are:

Controlled Room Temperature (CRT): +15°C to +25°C

Refrigerated: +2°C to +8°C

Freezer: -40°C to -20°C

Ultra-Low Freezer: -93°C to -60°C  

Cryogenic Freezer (LN2): -196 (aka dry shipper)

Biologics and stability

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