Join hundreds of scientists, managers and executives from around the world on October 21-23, 2013 in Washington DC at IBC's 17th Annual Well Characterized Biologicals. Ensure success in your CMC submissions by hearing all of the latest emerging regulatory/FDA guidelines directly from multiple regulators from FDA, Health Canada, US Pharmacopeia and the National Institute of Standards and Technology. Interact and discuss your current issues directly with these regulators who will share their expectations for higher order structure, vaccine assays, biosimilars, comparability, host cell proteins, particulates and impurities.We’ll help you establish confidence in your CMC submission & much more:
• Characterize ADCs, Bispecifics and Fusions to Help You Overcome the Challenges of More Complex Molecules
• Implement Improved CMC Strategies for Biosimilars and Vaccines So You Can Meet Regulatory Expectations in Your IND/BLA Submissions
• Improve Product and Process Comparability to Prepare for Both Scale-up Efforts and Manufacturing Site Changes
• Develop Functional Biological Assays and Evaluate Novel Analytical Technologies to Support Characterization of Monoclonal Antibodies and Other Diverse Products
• Analyze Host Cell Proteins, Impurities and Degradation Pathways to Help You Control Product and Process Quality
• Explore the Biophysical and Structural Properties of Your Molecules to Provide Better Information for Your Regulatory Dossier
To learn more, download our agenda!
As a reader of this blog, you’ll receive 15% off the standard rate when using code XB13193BLOG to register. If you have questions about the event, contact Kate Devery (Kdevery@iirusa.com), or visit our webpage.
We look forward to seeing you October 21-23 in Washington, D.C.
Cheers,
The Well Characterized Biologicals Team
WCB Webpage
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