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.
Organizer: Justin Shearer - GSK
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Annu Uppal - USP (United States Pharmacopeia)
Chi Zhang - GSK
Bingchuan Wei - Genetech
Ying Qing Yu - Waters Corporation
JC Chen - GSK
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Development, Application, and Implementation of Multi-Attribute Methodologies in the Pharmaceutical Industry
Justin Shearer - GSK
Considerations for Implementation of Multi-Attribute Methods for Biotherapeutics
Annu Uppal - USP
An Automatic Online Multiple Attribute Method Workflow for Real Time Product Quality Attributes Monitoring during the Monoclonal Antibody Biomanufacturing Process
Chi Zhang - GSK
Fly me to the MARS: Multi-attribute Raman Spectroscopy
Bingchuan Wei - Genentech
Recent advancements in Peptide MAM: Improvement on chromatographic performance for CQA peptides and New Peak Detection
Ying Qing Yu - Waters Corporation
High throughput Fast Capillary Electrophoresis-Mass Spectrometry Based Multi-Attribute Method Workflow for Simultaneous Monitoring of Multiple Product Quality Attributes for Cell Culture Processes
Jiangchao Chen - GSK
Development, Application, and Implementation of Multi-Attribute Methodologies in the Pharmaceutical Industry
Description
Session Number: O20-00
Session Type: Organized
Session Date: Wednesday 3/22/2023
Session Time: 8:30 AM - 11:25 AM
Room Number: 120A
Track: Bioanalytics & Life Sciences
Category: Bioanalytical, Pharmaceutical/Biologics, Quality/QA/QC
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