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Determination of protein purity
David G Rhodes1, Thomas M Laue
1Lipophilia Consulting, Storrs, Connecticut, USA.
Methods in Enzymology
|November 7, 2009
Summary
Quantifying protein sample purity is challenging. This work reviews methods for detecting protein impurities, crucial for data interpretation and biopharmaceutical safety.
Area of Science:
- Biochemistry
- Analytical Chemistry
- Biotechnology
Background:
- Direct quantification of protein sample purity is currently unavailable.
- Protein purity assessment relies on detecting or quantifying specific impurities.
- Ensuring protein purity is vital for accurate data analysis, process quality control, and biopharmaceutical safety.
Purpose of the Study:
- To review and discuss methods for detecting protein impurities in protein samples.
- To evaluate the capabilities and limitations of various impurity detection techniques.
- To provide a comprehensive overview of protein purity assessment strategies.
Main Methods:
- Focus on methods for detecting protein impurities.
- Description of techniques, their analytical performance, and constraints.
- Comparative analysis of different impurity detection approaches.
Main Results:
- No single method directly quantifies protein purity.
- Purity is inferred through the absence or quantification of specific impurities.
- Various analytical techniques offer different sensitivities and specificities for impurity detection.
Conclusions:
- Accurate protein purity determination is essential in protein science and biopharmaceutical development.
- Understanding the capabilities and limitations of detection methods is key for reliable purity assessment.
- This review serves as a guide to selecting appropriate methods for protein impurity analysis.
