A Rapid, Small-Volume Approach to Evaluate Protein Aggregation at Air-Water Interfaces

Journal of Pharmaceutical Sciences

Fecha de publicación: 30 de noviembre de 2020

DOI: https://doi.org/10.1016/j.xphs.2020.11.024

Autores: Caitlin V. Wood, Vladimir I. Razinkov, Wei Qi, Eric M. Furst, Christopher J. Roberts

Background: Non-native protein aggregation is a common concern for biopharmaceuticals. A given protein may aggregate through a variety of mechanisms that depend on solution and physico-chemical stress conditions. A thorough evaluation of aggregation behavior for a protein under all conditions of interest is necessary to ensure drug safety and efficacy. This work introduces a rapid, small-volume approach to evaluate protein aggregation propensity upon exposure to air-water interfaces (AWI). A microtensiometer apparatus is used to aerate a small volume of a protein solution with microbubbles for short periods of time (≤10 s). Sub-visible particles that form are captured and analyzed using backgrounded membrane imaging. This allows one to capture all particles in the solution while being sample sparing.

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