Challenges with Measuring Polysorbate Levels in Biopharmaceuticals
Posted on May 10, 2024
Shiranthi Jayawickreme, Regulatory Consulting, Syneos Health Clinical Solutions
(Previously Regulatory & Compliance Administrator at Duke Cancer Institute)
Loubna Tazi, Director, Analytical Sciences & Technology, Immunovant
(Previously Product Developement Scientist at 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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