Friday, September 27, 2013

FDA Perspective - Changing The Manufacturing Process to Remove Impurities

As the complexity of therapeutic protein increases, so do the challenges of controlling variants and impurities during process and product development, for scientists must continue to implement new methods and strategies to mitigate everything from quality control an assurance issues to immunogenic consequences.

Attend IBC's Product and Process Variants & Impurities conference to hear comprehensive updates on the latest approaches, methods, and technologies. to overcome these issues. An eclectic mix of regulatory, industry and academic speakers provide a diverse perspective on the topic, including:

• FDA perspective on changing the manufacturing process to remove impurities

• Industry panel discussion on biophysical methods to detect impurities

• Pfizer's technology roadmap to navigate the characterization landscape for increased product understanding

• University of Kent's list of challenges of product- and process related impurities to an evolving biopharmaceutical industry • Genentech's use of nucleic acid technologies to for early mutation detection

• NIST's sub-visible particle round-robin comparison on the level of agreement on sizing and counting

• Amgen's aggregation control strategy in manufacturing, QbD expectations and other process specifications

Want to learn more? Download our agenda.

As a member of the Bioanalytical Method Development group, you’ll receive 15% off the standard rate when using code XB13194BLOG to register. If you have questions about the event, contact Kate Devery (, or visit our webpage.

We look forward to seeing you October 21-23 in Washington, D.C!

The PPVI Team

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P.S. When you register for IBC’s Produce and Process Variants & Impurities conference, you’ll also have access to all sessions for our co-located event, Well Characterized Biologicals.

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