Intertek expert to present on advanced approaches to immunogenicity assessment

Published: 16-Jan-2013

Dr Nancy Emtage will describe advanced approaches to assess the level of neutralisation antibodies in serum

Intertek, a leading provider of quality and safety services to a wide range of industries around the world, will highlight advanced approaches to clinical immunogenicity assessment at Immunogenicity & Immunotoxicity, 31 January 2013, in San Diego, USA.

This inaugural conference brings together leading experts in industry, academia and the FDA. Important topics that will be covered include progress made in the areas of therapeutic protein immunogenicity and immunotoxicity evaluation such as protein aggregation, clinical relevance and assessment of immunogenicity, mitigation of immunogenicity-related risks, biosimilar development, and immunotoxicity evaluation strategies.

Nancy Emtage, bioanalytical immunochemistry expert in cell-based neutralisation assay, Intertek Pharmaceutical Services, will present on ‘Development and Validation of A Cell Based Assay for the Detection of Neutralizing Antibodies in Serum in Presence of High Levels of Drugs’ as part of the Clinical Relevance of Immunogenicity conference track.

‘It is important to understand the immune response to a novel biologic drug,’ says Dr Gouty, Senior Director, Intertek Pharmaceutical Services. ‘Each method and each compound is evaluated in a uniquely specific way in order to optimise the approach to assay development and ensure a comprehensive, scientifically sound validation; sometimes this means that advanced approaches are required to address potential challenges.’ Dr Emtage will describe advanced approaches to assess the level of neutralisation antibodies in serum.

Intertek Pharmaceutical Services Immunochemistry develops and validates GLP compliant cell-based and receptor-based assays for determining the presence of neutralising antibodies.

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