Did you ever receive a damaged package from the delivery service? It is annoying but can be replaced easily in most cases. Manufacturers of biopharmaceutical products, on the other hand, cannot risk any potential failures and must make sure that the product arrives reliably and safely. It is impossible to fix or rebuild the drug substance once it is damaged. Consequently, the value of the shipment is very high.
Therefore, we face many challenges when freezing, storing and shipping protein drug substance. In times of increased production efficiency for large quantities, this has become more and more important in the past decades. Freezing of biotherapeutics is a common unit operation, primarily used to extend the shelf life of the drug substance and provide flexibility in production and logistics. While technically simple to perform, the freeze-storage-thaw cycle comprises several mechanistic aspects that can compromise protein quality if not properly understood and addressed.
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