Establishing analytical workflows for complex biopharmaceutical molecules can help predict their risk of degradation.
raimund14/Stock.adobe.com
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.
Click
herefor a PDF of this article.
Submitted: Feb. 24, 2021
Accepted: April 9, 2021
Joana S. Cristóvão*, PhD, jscristovao@hovione.com, 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.
BioPharm International
Vol. 34, No. 9
September 2021
Pages: 34–40
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).
VERAXA and Voyager to Create Combined Business for Advancing Pipeline of Next-Gen Cancer Therapies
April 23rd 2025The proposed business combination would create a publicly traded, clinical-stage biopharmaceutical company that will focus on developing a pipeline of next-generation cancer therapies.
Tokyo University of Science Research Team Explores Improved Delivery of Antisense Oligonucleotides
April 18th 2025Using cholesterol-modified oligonucleotides, the research team aims to improve the delivery of antisense nucleotide-based therapies for treating neurodegenerative diseases and brain cancers.
Thermo Fisher Opens Advanced Therapies Collaboration Center in California
April 18th 2025The 6000-square-foot facility will provide cell therapy developers the support they need to transition to CGMP manufacturing, and an expanded footprint of the new center is expected to open in Philadelphia later in 2025.