An improved fluorescence method for direct optimization of challenging biopharmaceuticals formulations is showcased in an original research article in the December 2018 issue of SLAS Technology. This study demonstrates the feasibility of using a steady-state/lifetime fluorescence plate reader for direct optimization of challenging formulation conditions and highlights the importance of performing formulation optimization under commercially relevant conditions.
The goal of protein formulation development is to identify optimal conditions for long-term storage of biopharmaceuticals. Certain commercial conditions, such as high protein concentration or turbid adjuvanted samples can impart additional challenges to biophysical characterization. Formulation screening studies for such conditions are usually performed using a simplified format in which the target protein is studied at a low concentration in a clear solution. The failure of study conditions to model the actual formulation environment may cause a loss of ability to identify the optimal condition for target proteins in their final commercial formulations.
In this study, authors from the University of Kansas (Lawrence, KS, USA) utilize a steady-state/lifetime fluorescence-based, high-throughput platform to develop a general workflow for direct formulation optimization under analytically challenging but commercially relevant conditions. A high-concentration monoclonal antibody (mAb) and an Alhydrogel-adjuvanted antigen are investigated. A large discrepancy in screening results is observed for both proteins under these two different conditions (simplified and commercially relevant).
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