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Preview Past FDA Speaker Presentations
Top Ten List of Analytical Inadequacies in IND and BLA Submissions
Alfred Del Grosso
Team Leader, Analytical Chemistry
Regulatory Perspective on Comparability Assessments of Biotechnology Products
Audrey Jia, M.D., Ph.D.
Division of Monoclonal Antibodies
November 09-10, 2015 · Hyatt Regency Reston · Reston, VA
Get up-to-date with the global industrial biotherapeutic community from BioProcess International™ Magazine
Special Discounted Hotel Rate Available Until October 13, 2014. To book your room, call 1-800-635-5065 and mention that you are an IBC attendee at this event.
IBC's 19th Annual Well Characterized Biologicals meeting provides the regulatory guidance and analytical characterization strategies you need to ensure accurate CMC submissions.
For nearly two decades, this case-study driven event has led the industry by consistently providing the latest updates on the most novel bioanalytical methods for sound characterization of biologics.
With over 15 regulatory speakers, key insights on analytical method development and characterization strategies, and critical information on biosimilars, this year's event is a can't-miss.
Start planning your team's trip to this year's meeting and take advantage of this rare opportunity to meet and learn from multiple regulators, industry experts and leading national researchers who provide the guidance and lessons learned you need to improve your protein characterization efforts.
"An Incredible gathering of industry professionals sharing their unique and effective strategies for purification and characterization of Biotherapeutics." - Peter Jordan, Scilucent LLC
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:
"Well organized conference, wide variety of topics covered by the speakers." - Suranjana Haldar, Dr. Reddy's Lab LTD
As the longest and most comprehensive event on predicting and de-risking immune responses from creation to product, this year's event takes a deep-dive into critical issues for understanding and managing immunogenicity from concept to product.