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J Pharm Sci. 2016 Dec;105(12):3465-3470. doi: 10.1016/j.xphs.2016.09.003. Epub 2016 Oct 13.

Technical Decision Making With Higher Order Structure Data: Perspectives on Higher Order Structure Characterization From the Biopharmaceutical Industry.

Author information

  • 1Biopharmaceutical Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285. Electronic address:
  • 2Elion Labs, 1450 Infinite Drive, Louisville, Colorado 80027.
  • 3BioPharm Analytical Sciences, Biopharmaceutical Development R&D, GlaxoSmithKline, King of Prussia, Pennsylvania 19406.
  • 4Bioanalytical and Discovery Analytical Sciences, Research and Development, Bristol-Myers Squibb Company, Princeton, New Jersey 08543.
  • 5Janssen Research & Development LLC, Spring House, Pennsylvania 19477.
  • 6Biologics Development, Bristol-Myers Squibb Company, Pennington, New Jersey 08534.
  • 7Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, Connecticut 06877.
  • 8Protein Pharmaceutical Development, Biogen, Cambridge, Massachusetts 02142.
  • 9Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc., Chesterfield, Missouri 63017.


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.


biophysical methods; higher order structure; protein structure; proteins; quaternary structure; secondary structure; tertiary structure

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