Articles by Jon S. Kauffman, PhD - BioPharm International

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Articles by Jon S. Kauffman, PhD

Online Exclusive: Analytical Strategies for Monitoring Residual Impurities

Best methods to monitor product-related impurities throughout the production process.
Dec 18, 2009

Best methods to monitor product-related impurities throughout the production process.

Analytical Testing to Support Biopharmaceutical Products

Due to their complexity, biopharmaceuticals require a vast array of testing using orthogonal techniques.
Apr 2, 2007

A tremendous amount of analytical testing is required to support a biopharmaceutical product from discovery, development, and clinical trials, through manufacturing and marketing. Numerous methods are used to fully characterize large molecules because of their complexity—characterizing them is significantly more difficult than it is for small molecules. Biopharmaceuticals are produced via living systems, i.e., E. coli, yeast, or mammalian cells, which require additional testing matrices.

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