Immunogenicity for Biotherapeutics

Venue: Hyatt Regency Fishermans Wharf

Location: San Francisco, California, United States

Event Date/Time: May 23, 2005 End Date/Time: May 25, 2005
Early Registration Date: May 06, 2005
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As the FDA continues to develop risk analysis methods for the design and implementation of immunogenicity studies, it is imperative to keep current with the changing regulatory expectations to validate your immunoassays. As we enter our 6th year, our faculty remains committed to bringing you clarification on emerging regulatory guidances for assay validation and leading-edge information on new technologies to identify, characterize and reduce antibody and cell-based responses for development, preclinical and clinical environments.
This 6th annual conference provides new data on assay development and validation, screening and neutralizing assays, coupled with a concentration on the latest process techniques and technological advancements through all new, original case studies.
As the Immunogenicity conference has developed and grown, IIR has recognized the challenges faced by scientists working in immunogenicity and provided the first forum to exclusively address immunogenicity issues. For the first four years, we focused primarily on the antibody immunogenicity for biologics and vaccines. Beginning in 2004, and continuing through this year, we have expanded the agenda to include the latest cell based bioassay validation, screening and neutralizing assays, and improvement in processes and techniques.