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Emerging Analytical Technologies For Biotherapeutics Development
March 17, 2010
•Article: Emerging Analytical Technologies For Biotherapeutics Development
By Rajesh Krishnamurthy, Muppalla Sukumar, Tapan K. Das, and Nathan A. Lacher
A major goal of pharmaceutical development is to characterize pathways of chemical and physical instability and then to develop strategies to minimize them. Deamidation and oxidation are examples of the former, aggregation a result of the latter. The potential for the presence of multiple variants in protein-based pharmaceuticals highlights a need for analytical methods capable of reliably and accurately identifying and measuring those variants. The ideal analytical method would be sensitive, accurate, linear over a broad range, resistant to sample-matrix interference, capable of measuring all possible structural variants of a protein, and would allow for high throughput. Needless to say, such a method does not yet exist. So multiple methods are used to study the different characteristics of each protein.
Reprinted with permission from BioProcess International
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