Solid-state NMR spectroscopy: predicting stability in lyophilised biological products

The emergence of biological drugs has led to an increase in lyophilised drug products in the market. Lyophilisation is a technique used to stabilise parenteral formulations in a solid form with the goal of producing chemically and physically stable, homogeneous, and high-quality lyo-products.

The processes of freezing a formulation, followed by sublimation of the solvent to produce a lyo-cake, is extremely complicated, and demands further investigation of formulation design, stability, cycle development, and process scale-up to produce the highest quality lyo-product.

Proteins can be difficult to formulate as both chemical and physical stability must be considered. The protein needs to be formulated so that chemical degradation, such as deamidation, does not occur, whilst also assuring that the secondary and tertiary structure of the protein is stabilised against unfolding.1 Lyophilised formulations typically contain disaccharide sugars, such as sucrose or trehalose, both to stabilise the protein from unfolding and to create a glassy matrix. Low amounts of buffers are also added for ionisation control.

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