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Well Characterized Biologicals

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Case Studies, CMC Strategies, New Technologies and Regulatory Perspectives on Protein Characterization and Formulation Development for Biotechnology Products and Biosimilars

October 30 - November 01, 2012 · Omni Shoreham Hotel · Washington, DC

Event Overview

Event Overview

IBC's Well Characterized Biologicals conference is the leading industry conference to provide multiple, detailed case studies of the challenges, strategies and technologies involved in characterizing new biological molecules. You'll have the opportunity to learn about the CMC strategies for many different types of biological products, and interact directly with FDA regulators who will share best practices and expectations for well-characterized products. No other conference on the market provides more case studies and unpublished new data that you can only hear about by attending this event. Find strategies for legacy products, new complex molecules, vaccines, combination products, biosimilars, ADC's, bispecifics and other recombinant proteins.

New This Year! 2nd Conference Track Added to IBC's Well Characterized Biologicals event:

Drug Product Formulation and Delivery

Complementing the current emphasis on analytical strategies for Drug Substance, this new, concurrent track will feature Drug Product strategies and technologies for complex formulations, delivery systems and devices, so you can cross-fertilize ideas with attendees from different disciplines... analytical development, process development and formulation development... for better characterized biologicals!

Call for Speakers

We are now accepting proposals for speaking slots at the 16th Annual Well Characterized Biologicals.

Please consider submitting an abstract in one of the following topic areas:

  • CMC Strategies for Biosimilars
  • Comparability Strategies
  • Case Studies of Well Characterized Biologicals
  • Characterization and Comparability of Vaccines and Protein Products
  • CMC Strategies for Complex Products and Combination Products
  • Functional Biological Assays
  • Assessment and Characterization of Aggregates, Particles and Impurities
  • Biophysical Characterization Strategies
  • Regulatory Perspectives
  • Emerging Technologies for Protein Characterization
  • Formulation Development
  • Drug Product Delivery
  • Integrated Formulation and Delivery

» Call for Papers Submission Deadline: Friday, April 13 | Submit your proposal today!

"IBC's Well Characterized Biologicals meeting brings together researchers who are actually doing the work and discusses the big picture of CMC issues and expectations for protein characterization presented directly by FDA scientists" - Nadine M. Ritter, Ph.D., Senior CMC, Consultant, Biologics Consulting Group, Well Characterized Biologicals Conference Advisor

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