Biophysical Characterization for Product Comparability - Spectroscopic methods such as circular dichroism can detect subtle differences in higher order structure before and after changes in process

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Biophysical Characterization for Product Comparability
Spectroscopic methods such as circular dichroism can detect subtle differences in higher order structure before and after changes in process and formulation.


BioPharm International Supplements


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,
Yin Luo, PhD, is a director in analytical research and development, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc., Andover, MA,

References

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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.

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