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Establishing analytical workflows for complex biopharmaceutical molecules can help predict their risk of degradation.
Biopharmaceuticals are complex molecules with a variety of functional groups that are susceptible to instability through different degradation pathways. Protein degradation may arise as a result of exposure to different environmental changes and stresses throughout the product lifecycle. Molecular variants arising during manufacture and/or storage may not have properties comparable to those of the desired product with respect to their activity, efficacy, and most importantly, safety. Therefore, it is crucial to set up analytical workflows to understand the intrinsic biochemical and physical stability of these molecules and predict the risk of degradants formation. This paper describes the application of biophysical stability parameters that measure solution-mediated interactions and key structural characteristics of model proteins that will enable a fast assessment of conformational and colloidal stability of biopharmaceuticals.
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Submitted: Feb. 24, 2021
Accepted: April 9, 2021
Joana S. Cristóvão*, PhD, firstname.lastname@example.org, is an analytical scientist, and Salomé Neto was a Master’s student, both with Hovione Farmaciência S.A., R&D, Analytical Development.
*To whom all correspondence should be addressed.
Vol. 34, No. 9
When referring to this article, please cite it as J.S. Cristóvão and S. Neto, “Conformational and Colloidal Stability Studies to Predict the Best Biopharmaceutical Formulation,” BioPharm International 34 (9) 34–40 (2021).