Immunogenicity of Protein Therapeutics 2011

Keynote Presentations

Understanding the Impact of Aggregates on Immunogenicity

Jack Ragheb, Ph.D., Senior Regulatory Research Officer and Principal Investigator, Therapeutic Proteins, FDA

Large protein aggregates are known to be produced during the pharmaceutical manufacturing of therapeutic protein products. However, our understanding of how protein aggregate attributes such as size contribute to this immunogenicity is very limited. This talk will focus on subvisible protein aggregates, how they may interact with the immune system, and the potential impact these particles could have on a product’s safety and efficacy profile.

Protein Aggregation and Immunogenicity: The Formulation Matters

Wim Jiskoot, Ph.D., Professor, Drug Delivery Technology, Leiden University

In this talk I will present product-related risk factors for protein immunogenicity, with a focus on aggregation. Clinical case studies illustrating the importance of the formulation in relation to protein immunogenicity will be presented. Moreover, theoretical considerations and pre-clinical studies pointing to which types of aggregates (including subvisible particles) may serve as a risk factor will be discussed.