Printed from the IBC Life Sciences Web site on December 12, 2013 11:31 PM ET.
Page location: http://www.ibclifesciences.com/variants/overview.xml
October 21-23, 2013 · L'Enfant Plaza Hotel · Washington, DC
Standards for the Optical Detection of Protein Particles
Dean C. Ripple, Joshua R. Wayment, Michael J. Carrier
Biochemical Science Division
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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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.
"This conference is very much in line with my daily work of purification of proteins and characterization of process related or produce relate impurities. I wish to gain a better understanding and knowledge of industry techniques for characterizing impurities and developing methods by chromatography or other to remove them to improve overall process performance and achieve higher overall purity with our process." - Michael Grady, Associate Scientist, Protein Science, Ambrx Inc.
Session Topics This Year Include:
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