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Room Temperature Intrinsic Emission Ratio of BSA Correlates With Percent Aggregates During Long-Term Storage

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Room Temperature Intrinsic Emission Ratio of BSA Correlates With Percent Aggregates During Long-Term Storage

Journal of Pharmaceutical Sciences

Fecha de publicación: 27 de octubre de 2020

DOI: https://doi.org/10.1016/j.xphs.2020.12.019

Autores: Joel D. Manrrique, Zakiya K. Powell, Ryan M. Brock, Cynthia E. Franklin, Adeola O. Coker

Background: Successful formulation development hinges on the ability to screen and identify excipients that stabilize drug products during long-term storage. Biophysical and accelerated stability studies are used to screen for excipients that stabilize protein drug products. However, these studies are not always predictive of aggregation during long-term storage. In this study, we used multivariate experimentation to compare the effectiveness of intrinsic fluorescence and size exclusion chromatography accelerated stability parameters to predict excipients that stabilized bovine serum albumin (BSA) against aggregation on long-term storage at 4 °C. Emission intensity ratio (IR330/350) data was more sensitive than emission maxima (λmax) or intensity measurements in identifying significant factors and interactions.

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