Workshop Co-organized by IABS and Health Canada

Scientific Committee

Anthony Lubiniecki
Chair; Pharmaceutical Development & Manufacturing Sciences, Janssen R&D LLC, Malvern, Pennsylvania, USA
John Carpenter
University of Colorado, Aurora, Colorado, USA
Barry Cherney
Amgen Inc, Thousand Oaks, California, USA
Susan Kirshner
Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
Ewa Marszal
Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
Anthony Ridgway
Health Canada, Ottawa, Ontario, Canada
Dean Ripple
National Institute of Standards and Technology, Gaithersburg, Maryland, USA
David Volkin
University of Kansas, Lawrence, Kansas, USA

Meeting management:

Geneva, Switzerland

Objectives of the Workshop

In 2009, IABS and FDA cosponsored a conference which focused on:

  • the mechanism of protein folding
  • the characteristics of sub visible and visible protein particles that may influence immunogenicity including the size, type (reversible, protein class), composition, amount, and conformational status)
  • the risks associated with the propensity to generate immune responses including the route of administration, dose, and frequency, duration of administration and indication
  • the factors that influence the formation of large protein aggregates and methods to reduce protein aggregation (approaches in formulation, and protein design) including case studies of occurrence of these particulates in manufacturing
  • analytical methods that are useful in quantifying these particles and approaches to the design of suitable control strategies that mitigate the risk to product quality.

IABS and Health Canada will revisit these topics in light of what has been learned in the past 6 years. Progress in understanding the science of protein particle formation, the evolution of the analytical technologies for characterization and measurement of sub-visible protein particles, the advances in standardization of protein particle measurements, and their possible relationship of protein particle attributes to safety and efficacy of biotherapeutics will be highlighted. The goal of the meeting is to assess the progress of the past half-decade, and its implications for risk management during biotherapeutic product development.