Among the list of over 300 FDA and EMA approved biopharmaceutical products, around 50% are freeze-dried – indicating that freeze-drying is the preferred way of stabilising biopharmaceutical drug products that are unstable in aqueous solution, despite the high cost and long processing time linked to this manufacturing technique.
Freeze drying is a low-temperature drying process, based on the principles of heat and mass transfer, employed to convert aqueous solutions of (heat-)labile materials into solids with sufficient stability for distribution and storage.3 Many biopharmaceuticals have limited stability in aqueous solution and are subject to a number of degradation pathways mediated by water, which might result in a lower potency or even in toxicity of the drug molecule.
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