Wednesday, August 21, 2013

Identify Control Variants & Impurities

IBC’s Inaugural Product and Process Variants & Impurities event will help you eliminate the fear factor around product and process variants and impurities by gaining real, executable solutions that all biologic and protein therapeutic makers face with 19 case studies and 20 unpublished data presentations. Optimize the process and product quality for your products by building in variant and impurity control protocols through supply chain management, manufacturing enhancements, assays, physiochemical and characterization date.

Control, Reduce and Eliminate Your Variants and Impurities:

• Navigate the Characterization Landscape for Increased Product Understanding and Speed with Pfizer's Technology Roadmap

• Hear the Level of Agreement on Sizing and Counting from 24 Laboratories in the NIST's Subvisible Particle Round-Robin Comparison

• Apply Regeneron Pharmaceutical's Strategy to Characterize Subvisible Particles Impact on Virus Filters for Robust Process and Production

• Learn How AbbVie Uses Stable Isotope-Tagged Reference Standards and Analytical Tools for Detecting Variants and PTMs at Low Levels and Maintaining Manufacturing Consistency

• Discover How Genentech is Using Nucleic Acid Technologies as Complementary Tools for Early Mutation Detection

• Set Proactive Steps for Manufacturing, QbD Expectations and other Process Specifications with Amgen's Aggregation Control Strategy

Want to learn more? Download our agenda.

As a reader of this blog, 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!

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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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