Qualification of Biophysical Methods for the Analysis of Protein Therapeutics

  • Yijia Jiang
  • Cynthia Li
  • John Gabrielson
Part of the Biophysics for the Life Sciences book series (BIOPHYS, volume 4)


Biophysical techniques such as analytical ultracentrifugation (AUC), circular dichroism (CD), and differential scanning calorimetry (DSC) have been widely used by the biopharmaceutical industry to study higher-order structure of protein therapeutics. The data generated have generally been included in regulatory filings as part of the elucidation of structure and other characteristics and pharmaceutical development. In recent years, there is increasing scrutiny from the regulatory agencies on the qualification of these techniques. This chapter provides an overview of the biophysical methods used for generating information for regulatory filings during protein therapeutics development, purposes of these analyses, qualification approaches of these methods, any gaps present, and future directions.


Differential Scanning Calorimetry Circular Dichroism Protein Therapeutics Circular Dichroism Spectroscopy Sedimentation Coefficient 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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© Springer Science+Business Media New York 2013

Authors and Affiliations

  1. 1.Process and Product Development, Amgen Inc.Thousand OaksUSA
  2. 2.Process and Product Development, Amgen Inc.Thousand OaksUSA
  3. 3.Analytical Sciences, Amgen Inc.LongmontUSA

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