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Development, Application, and Implementation of Multi-Attribute Methodologies in the Pharmaceutical Industry
Description:
The development of Multi-Attribute Methodologies (MAM) has been gaining momentum for many years. MAM methods provide advantages as they can permit the reporting of multiple attributes in a single test. For example MAM methods permit the quantitation and/or the identification of a target/antigen/adjuvant, quantitation of different product attributes/characteristics, and/or quantification of the same attribute of multiple antigens in a single analysis. This session will highlight the development, implementation, and application of MAM methods as they apply to multiple modalities of pharmaceuticals. The session will include a focus on biopharmaceuticals and vaccines as well as some regulatory considerations and perspectives.
Speaker: Justin Shearer - GSK
Co-Authors
Development, Application, and Implementation of Multi-Attribute Methodologies in the Pharmaceutical Industry