Immunogenicity of Protein Therapeutics 2011
May 12 - 13, 2011
Boston MA , USA
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.
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.
Venue
Location: Sheraton Boston Hotel & Towers
Contact
Prudential Center, 39 Dalton St. Boston , USA
Related events
Immunogenicity of Protein Therapeutics April 29 - 30, 2015
Immunogenicity of Protein Therapeutics May 7 - 8, 2014
Immunogenicity of Protein Therapeutics April 29 - 30, 2013
Immunogenicity of Protein Therapeutics May 3 - 4, 2012
Immunogenicity of Protein Therapeutics May 12 - 13, 2011
