Optimizing the Vehicle for High Concentration Protein Suspensions

Growing interest to transition monoclonal antibody therapies from intravenous to subcutaneous delivery is driving the need for more advanced drug delivery systems. One emerging approach involves suspensions of solid-state protein particles in non-aqueous vehicles, which has the potential to improve protein stability, reducing the need for cold chain storage, and to mitigate viscosity challenges seen in high-concentration protein solutions. Achieving viable formulations depends on maximizing protein loading in both the particles and the suspension while maintaining acceptable injectability and stability. Among key factors like particle design, formulation, and manufacturing, the choice of suspension vehicle plays a central role, influencing injectability, stability, and patient tolerability. In this perspective article, we aim to highlight the complexity and nuance of vehicle selection as it relates to performance and stability in these high concentration protein suspensions. Given limited existing data, better understanding of how vehicle properties affect performance is encouraged to the enable successful development of high-concentration protein suspension into viable drug products.

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Authors:

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Cindy Chung, PhD

Principal Engineer

Process and Product Development

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Erica Schlesinger, PhD

VP Technology Development

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