Institute for International Research

IBC's Well Characterized Biologicals conference is the leading industry conference to provide multiple, practical case studies of the challenges, strategies and technologies involved in protein characterization. You'll hear from numerous speakers about lessons learned from process changes that worked or didn't work. By attending, you can benchmark your own practices against industry leading companies and find out how others are tackling common issues related to analytical testing methods, new technologies and regulatory requirements. Find out how to navigate the ever-changing regulatory landscape as characterization techniques become more advanced and protein products become more complex. Share successful strategies and best practices with fellow scientists and regulatory officials to help you optimize your product and process knowledge. Register today and find out why IBC's Well Characterized Biologicals conference has been one of the bioprocess industry's most respected, must-attend events for over 12 years.

Scientific Advisory Committee
Updated: May 11, 2009

• Reed Harris, Director, Analytical Development, Genentech, Inc.
• John P. Hennessey, Jr., Ph.D., Vice President, Research & Development, NovaDigm Therapeutics, Inc.
• Alan V. Klotz, Ph.D., Research Advisor/CM&C Leader, Elanco Biosciences
• Joseph Kutza, Ph.D., Associate Director, CMC Regulatory Affairs, MedImmune
• Ned Mozier, Ph.D., Director, Analytical Sciences, Global Biologics Research and Development, Pfizer, Inc.
• Michael G. Mulkerrin, Ph.D., Vice President, Process Development, OncoMed Pharmaceuticals
• Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group
• Richard Strong, Ph.D. Senior Scientist, Analytical Development, Biogen Idec

Case Studies of Characterizing Biologicals

• Characterization strategies for recently approved molecules
• Process changes that worked/didn't work
• Post-approval issues that surfaced that were not found in clinical trials
• Characterizing Aggregates and aggregation pathways
• Applications of new technologies or new applications of older technologies
• Host cell impurities
• Process drift and comparability
• Beyond IgG1: Analytical profiles of IgG2, IgG3, IgG4, etc.

Characterizing Complex Protein Products

• Conjugate products
• Bispecific proteins
• Proteins as intermediates
• PEGylated molecules
• Fusion molecules

New Analytical Methods, Novel Expression Systems and Emerging Uses of Classical Technologies

• Effective tools for process analytics
• Regulatory perspectives on newer analytical technologies
• Novel expression systems: plant cell lines, etc.
• Bioprocess applications of TR FRET
• Measuring biophysical and chemical properties: in stability, etc.

Regulatory Perspectives

• Guidelines for extractables and leachables
• Specifications for and safety of raw materials
• Biophysical testing techniques and subvisible particulates
• Complex protein products - bispecifics, conjugates, combination products
• Impact of new technologies and low level heterogeneity
• Reprocessing and reworking/risk management
• Setting clinical stage and commercial characterization specifications
• Product quality versus product consistency
• Comparability guidances and an update on follow-on biologics
• Expectations for potency assays throughout the product lifecycle

Assessing Structure/Function Relationships

• Glycosylation patterns
• Post-translational modifications
• Immunogenicity
• Disulfide and trisulfide scramblings
• in vitro and in vivo methods

Follow-on Biologics

• FDA perspectives
• Clinical testing requirements
• Case studies of approved or emerging follow-on biologics
• Characterization and comparability: How similar is similar?

Other Considerations for Well Characterized Biologicals

• Selecting the right molecule and/or appropriate cell line with the right analytical profile at an early stage
• High-throughput cell line selection
• Defining critical quality attributes
• Global manufacturing/supply chain to ensure product quality and consistency