Challenges with Measuring Polysorbate levels in Biopharmaceuticals
Posted on November 3, 2016
By: Shiranthi Jayawickreme, Regulatory & Compliance Administrator Duke Cancer Institute Loubna Tazi, Product Developement Scientist Biogen, Inc.
Introduction A variety of detergents are used for solubilization, viral-inactivation, and as excipients in Biopharmaceutical Drug substances and products. Lack of chromophores in many of these detergents poses a challenge for the detection and quantitation of these components during process developm...
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Related Topics and Keywords
biogen, excipients, Loubna Tazi, Polysorbate, Shiranthi Jayawickreme
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