| Literature DB >> 27743675 |
William F Weiss1, John P Gabrielson2, Wasfi Al-Azzam3, Guodong Chen4, Darryl L Davis5, Tapan K Das6, David B Hayes7, Damian Houde8, Satish K Singh9.
Abstract
Characterization of the higher order structure (HOS) of protein-based biopharmaceutical products is an important aspect of their development. Opinions vary about how best to apply biophysical methods, in which contexts to use these methods, and how to use the resulting data to make technical decisions as drug candidates are commercialized [Gabrielson JP, Weiss WF IV. J Pharm Sci. 2015;104(4):1240-1245]. The aim of this commentary is to provide guidance for the development and implementation of a robust and comprehensive HOS characterization strategy. We first consider important concepts involved in developing a strategy that is appropriately suited to a particular biologic, and then discuss ways industry can partner with academia, technology companies, government laboratories, and regulatory agencies to improve the consistency with which HOS characterization is applied across the biopharmaceutical industry.Keywords: biophysical methods; higher order structure; protein structure; proteins; quaternary structure; secondary structure; tertiary structure
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Year: 2016 PMID： 27743675 DOI： 10.1016/j.xphs.2016.09.003
Source DB: PubMed Journal: J Pharm Sci ISSN： 0022-3549 Impact factor: 3.534