Take Part in Process and Product Variants & Impurities 2013

• Attend - Register by July 12 and Save $450
• Present a Poster - Submit an abstract by September 20; Get faster approval to attend
• Sponsor/Exhibit

Co-Located With

IBC's 17th Annual
Well Characterized Biologicals
October 21-23, 2013

Access Any Session at These Co-located Events for One Price!

Special Discounted Hotel Rate

Special Discounted Hotel Rate Available Until September 23, 2013. To book your room, call 1-800-635-5065 and mention that you are an IBC attendee at this event.

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Make New Contacts and Enjoy Dinner with Fellow Attendees

A dinner sign-up sheet will be provided during the conference to allow you to connect with other attendees who are interested in meeting others for dinner after the conference sessions.

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The Only Industry Forum Covering Recommended Practices and Control Strategies for All Types of Product- and Process-Related Variants and Impurities

IBC's Inaugural Product and Process Variants & Impurities conference explores the major classes of product and process-related impurities that can affect the safety, efficacy, and overall structure of a molecule targeted for a biologic or protein therapeutic. Moreover, this topic provides a forum for process developers to explore methods and novel approaches that provide ways to characterize and analyze variants and impurities, as well as consider mechanisms for executing corrective and preventative actions.

Regulatory and Industry Perspectives on Controlling Variants and Impurities, Monitoring Quality and Addressing Future Challenges

Session Topics This Year Include:

• Analytical Methods and Technologies for Identifying and Controlling Product-Related Variants and Impurities
• Process Monitoring and Control Strategies for Purifying Variants and Impurities
• Regulatory and Scientific Organization and Industry Perspectives on Process Variants and Impurity Characterization
• Aggregation and Subvisible Particles
• Variant and Impurity Challenges in Vaccine Development and Production
• Host Cell Protein Characterization and Control
• Characterization of Degradation Pathways
• Biophysical and Structural Characterization Strategies

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Featured Presentations

Changing the Manufacturing Process to Remove Impurities and Monitoring Product Quality Using Relevant Lot Release Assays
Mikhail V. Ovanesov, Ph.D., CBER, US FDA

The Challenges of Product- and Process-Related Impurities to an Evolving Biopharmaceutical Industry
C. Mark Smales, Centre for Molecular Processing & School of Biosciences, University of Kent, United Kingdom

Practical Considerations to Characterize and Control Protein Aggregates During the Development Cycle and Commercialization with a Focus on the Visible Size Range
Erwin Freund, Ph.D. Scientific Executive Director, Drug Product Engineering, Amgen Inc.

"A top event with the rare opportunity to interact with FDA representatives in an informal setting. This key conference brings together industry experts and regulators who will provide insight regarding the latest technologies and regulatory expectations you need to consider as you develop your product and process impurity control strategy." - Penny Post, Ph.D., Vice President, Regulatory, Protein Sciences Corporation