Product and Process Variants & Impurities

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Find Practical Strategies and New Techniques to Help You IBC’s 17th Annual Well Characterized Biologicals More Case Studies and Unpublished Data You Can Apply in Your CMC Programs Register today to hear practical advice in these critical areas that you can apply in your own lab: • Characterize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 Featured FDA Presentation Top 10 List of Analytical Inadequacies in IND or BLA Submissions Alfred Del Grosso, CBER, US FDA Tuesday, October 22 • 10:15 am • 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 Avoid Common Pitfalls in Your Analytical and CMC Studies Case Studies and Lessons Learned from: Amgen, Genentech, ImmunoGen, Oncomed, AbbVie, Sandoz, Biogen Idec, Millenium/Takeda, Merck, MedImmune, Novavax, Sanofi Pasteur and more! One Registration Fee Gives You Access to Two Call for Poster Presentations and Best Poster Award Consider presenting a poster at this conference to derive more value from attending. Share your research with your peers and learn from other posters as well. Many attendees tell us that being selected for a poster presentation helps to facilitate their company approval process to attend the conference. All posters will be reviewed by the conference advisory board and a Best Poster Award will be presented during the conference. Submit your poster abstract online today at www.IBCLifeSciences.com/WCB or www.IBCLifeSciences.com/Variants. Poster abstract submission deadline: September 20, 2013. Oral Poster Presentation Session Several poster presenters will be chosen to provide a short oral presentation of their poster during the conference sessions. Submit your poster abstract today for a chance to be selected for this opportunity. 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. Regulatory Advice You Can Apply With 8 confirmed speakers from FDA and Health Canada, along with other regulatory/policy experts from the US Pharmacopeia and industry, you’ll walk away from this conference with an update on changing regulatory guidances and clearer regulatory expectations for your molecules. Many more FDA speakers have been invited to present. Please visit the conference websites for updates as they confirm. “Great conference! I learned a lot and got some great ideas for the development of in-house methods. I thought the FDA presentations were terrific…and put the fear of God in me” – Jacqueline McGourty, Associate Director, Emergent Biosolutions 2 Register Early for Best Savings • Up-to-date Program Information • www.IBCLifeSciences.com/WCB
Meet Regulatory Expectations for a Wide Range of Molecules IBC’s Inaugural Product and Process Variants & Impurities The Only Industry Forum Covering Variant and Impurity Control and Mitigation Strategies • 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 Featured FDA Presentation Changing the Manufacturing Process to Remove Impurities and Monitoring Product Quality Using Relevant Lot Release Assays Mikhail V. Ovanesov, Ph.D., CBER, US FDA Tuesday, October 22 • 8:15 am Conferences and Shared Exhibits, Posters & Networking View New Technology in the Exhibit Hall Enhance Your Process Development Efforts to Mitigate Product- and Process-Related Variant and Impurities Case Studies and Leadership Insights from: AbbVie, ABC Laboratories, Amgen, Bristol-Meyers-Squibb, Boehringer Ingelheim, Genentech, Genzyme, Merck, NIST, NIBRT, Pfizer, Protein Sciences Corp., Regeneron Pharmaceuticals, SAFC Carlsbad, SAIC-Frederick, University of Kent and Waters Find new analytical technologies, products and services to help you with your product characterization efforts in the exhibit hall. Both conferences share all exhibit and networking breaks so you will have an opportunity to meet with vendors and technology providers from both events all under one roof. Participate in “Hot Topic” Roundtable Discussions Moderated by FDA and Industry Speakers Discuss and debate important industry issues with other attendees and speakers during these informal, “Hot Topic” roundtable discussions moderated by conference speakers. To suggest a topic you would like to discuss, please email Michael Keenan at mkeenan@ibcusa.com or Mark DeSorbo at mdesorbo@ibcusa.com. Who Should Attend These co-located conferences offer too much content for just one person. Send a team from your company to capitalize on this unique opportunity to meet face to face with multiple regulators and to benefit from hearing unpublished data that will only be shared in person at these conferences. The practical advice and industry case studies at this event will benefit Scientists, Technicians, Managers, Lab Heads, Directors and other specialists in the following departments: • Analytical R&D • CMC • Protein Analytical Chemistry • Bioassay Development • Regulatory Affairs and QA/QC • Process Development • Product Development • Technical Operations/Manufacturing Sciences • Drug Product Manufacturing • Clinical Supply Chain Procurement Send a Group of 3 and the 4th goes FREE! For more information on group pricing or to register a group, call our group sales advocate at 646-895-7445 “I enjoyed the conference. There was plenty of new knowledge gained from the presentations and new opportunities for networking with colleagues in the industry” – Bridgitte Speights, Director, CMC Regulatory Affairs, Teva Register Early for Best Savings • Up-to-date Program Information • www.IBCLifeSciences.com/Variants 3
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