Process and product related impurities in therapeutic products can lead to adverse events. When CMC information related to the adverse events are available, the potential risk could be reduced by controlling the levels of the implicated impurities through changes in the manufacturing process and monitoring the quality of the product using relevant lot release assays. So where do you start?Session: FDA Perspective - Changing the Manufacturing Process to Remove Impurities and Monitoring Product Quality Using Relevant Lot Release Assays
Speaker: Mikhail V. Ovanesov, Ph.D, Visiting Scientist, Principal Investigator, Laboratory of Hemostasis/Division of Hematology, Officer of Blood Research and Review, CBER, US FDA
Want to hear more about how changing the manufacturing process can remove impurities? Join us this October at the IBC's Inaugural Product Process Variants & Impurities Event.
For more information, download our brochure. Register today for the only industry forum covering variant and impurity control and mitigation strategies! We look forward to seeing you October 21-23 in Washington, DC.
As a reader of this blog, you'll receive 20% off the standard rate when you mention code XB13194BLOG to register.
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