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Immunogenicity Prediction and Mitigation
October 11-12 

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Part Two at CHI’s Immunogenicity Summit 2012 begins with the Joint Plenary Session which presents Regulatory Guidance from the FDA together with a panel discussion, and a background to causes and avoidance of immunogenicity from a top academic Immunologist. It then launches into factors that contribute to immunogenicity such as subvisible particles and aggregates. The last day provides predictive immunogenicity assessment strategies from the FDA and all the top companies: Amgen, Genetech, and Pfizer.

THURSDAY, October 11 


4:00 Chairperson’s Opening RemarksVibha Jawa, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.                


 4:05 Subvisible Particles in Protein Therapeutics and Immunogenicity: Is There a Link?

Andrew Brooks 2010Wim Jiskoot, Ph.D., Professor, Division of Drug Delivery Technology, Leiden University - Biography 

Practically all protein therapeutics are immunogenic and contain subvisible particles (SVPs). Although it is tempting to assume a correlation, our current understanding about the contribution of SVPs to protein immunogenicity is still limited. In this presentation I will address the following question related to the presence of SVPs in protein therapeutics: where do they come from; what is their nature; how can we characterize and quantify them; which tools do we have to assess their contribution to unwanted protein immunogenicity?


4:35 Photooxidation-Enhanced Immunogenicity

Andrew Brooks 2010Theodore W. Randolph, Ph.D., Gillespie Professor of Bioengineering, Chemical and Biological Engineering, University of Colorado - Biography 

During manufacture, therapeutic proteins may be exposed to ultraviolet (UV) radiation which may cause photooxidative damage, which in turn could lead to physical changes such as aggregation and enhanced immunogenicity. We exposed murine growth hormone (mGH) to controlled doses of UV radiation, and examined the resulting chemical, physical and immunogenic changes in the protein. When administered subcutaneously to mice, UV-irradiated mGH provoked T-cell dependent immune responses, but no immunological memory. mGH immunogenicity increased with increasing UV radiation doses.

Jackson Laboratory 5:05 Reconstitution of the Human Immune System in Mice: Utility in Preclinical ResearchLeon L. Hall, Ph.D., Director, Scientific Operations, in vivo Pharmacology Services, The Jackson LaboratoryDrug discovery research requires predictive animal models that can better mimic human biology.  Immunodeficient mice engrafted with a human immune system enable scientists to study human biological processes in vivo without putting patients at risk.  The mice with an engrafted human immune system represent one form of humanized mouse models and leverage the severely immunodeficient mouse strain, NOD scid IL2 receptor gamma chain knockout mice (NSG) which readily supports the engraftment and multi-lineage differentiation of human hematopoietic stem cells.  This presentation will discuss various methodologies to establish engraftment, functional characterization of the reconstituted human immune system andresearch applications in a broad range of therapeutic areas such as infectious disease, hematopoiesis, stem cell differentiation and autoimmune disorders.  Preliminary data on immunogenicity testing of protein drugs in the humanized mice will also be discussed.

Andrew Brooks 20105:35 Working Towards Building a “Value Added Proposition” for Immunogenicity Prediction and Risk Management 

Manoj Rajadhyaksha, Ph.D., Director, Bioanalytical Sciences, Regeneron, Inc. - Biography 

The immunogenicity profile of a biotherapeutic is determined by a multiplicity of factors ranging from product related, patient (host) related, bioanalytical to process or manufacturing related factors. This creates a complex situation that does not allow direct correlation of such risk factors to the observed incidence of immunogenicity. Therefore, a mechanistic understanding of how these risk factors individually or in concert influence the overall incidence and risk of immunogenicity is crucial to design the best benefit/risk profile for a given biotherapeutic in a given indication. 

6:05 - 7:00 Networking Reception in the Exhibit Hall with Poster Viewing

7:00 End of Day One of Immunogenicity Prediction and Mitigation

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Part One | Part Two



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