Acknowledgements
We thank James Carroll, John Steckert, and Ned Mozier for scientific discussion, and Zhaojiang Lu, Monica Brzezinski, Justin
Sperry, Mike Dupuis, Min Huang, and Philip Boyle for technical assistance and material supply.
QIN ZOU, PHD, is a senior principal scientist in analytical research and development, BioTherapeutics Pharmaceutical Sciences, Pfizer
Inc., Chesterfield, MO, 636.247.1257, qin.zou@pfizer.com
Yin Luo, PhD, is a director in analytical research and development, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc.,
Andover, MA, yin.lou@pfizer.com
References
1. Rosenberg AS. Effects of protein aggregates: an immunologic perspective. AAPS J. 2006;8:E501–07.
2. US Food and Drug Administration. Guidance for Industry: Q5E Comparability of biotechnological/biological products subject
to changes in their manufacturing process. Rockville, MD; 2005.
3. European Medical Association. Guideline on comparability of medical products containing biotechnology-derived proteins
as active substance: quality issues. Geneva; Switzerland. 2003.
4. EMA. Guideline on similar biological medicinal products containg biotechnology-derived proteins as active substance: quality
issues. Geneva, Switzerland; 2005.
5. Sreerama N, Woody RW. Estimation of protein secondary structure from circular dichroism spectra: Comparison of CONTIN,
SELCON, and CDSSTR methods with an expanded reference set. Anal Biochem. 2000;287:252–60.
6. Tetin SY, et al. Accuracy of protein secondary structure determination from circular dichroism spectra based on immunoglobulin
examples. Anal Biochem. 2000;321:183–7.
7. Khrapunov S. Circular dichroism spectroscopy has intrinsic limitations for protein secondary structure analysis. Anal
Biochem. 2009;389:174–6.
8. Mächtle W. High-resolution, submicron particle size distribution analysis using gravitational-sweep sedimentation. Biophys
J. 1999;76:1080–91.
9. Schuck P. Size-distribution analysis of macromolecules by sedimentation velocity ultracentrifugation and Lamm equation
modeling. Biophys J. 2000;78:1606-19.
10. Stafford WF, Braswell EH. Sedimentation velocity, multi-speed method for analyzing polydisperse solutions. Biophys Chem.
2004;108:273–9.
11. Stafford WF, Sherwood PJ. Analysis of heterologous interacting systems by sedimentation velocity: Curve fitting algorithms
for estimation of sedimentation coefficients, equilibrium and rate constants. Biophysical Chem. 2004;108:231–43.
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