Validation of LC-MS Multi-Attribute Method (MAM) Supporting Biopharma Process Characterization

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An automated multi-attribute method (MAM) approach providing high-throughput, user-friendly analysis of process validation samples is moving mass spectrometry toward biopharma quality control. Learn how to implement automated MAM approaches for process development and validation and streamline approaches using a single scalable enterprise software platform. Live: Tuesday, Jun. 30, 2020 at 10am EDT | 9am CDT | 2pm BST | 3pm CEST On demand available after final airing Jun. 30, 2021 Register free

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Event Overview:

Multi-attribute method (MAM) approaches to characterizing and monitoring the production of biopharmaceuticals offer the ability to replace multiple analytical technologies with a single mass spectrometry (MS) analysis. Assessing multiple critical quality attributes (CQAs) at the molecular level delivers a comprehensive understanding of the end product; ultimately enabling a true quality-by-design approach to biotherapeutic development.

Routine use of LC-MS MAM requires overcoming many scientific, technological and methodological challenges:

  • Managing large amounts of information-rich MS data generated by highly robust methods,

  • Producing unbiased and fully audited results that are generated using standardized procedures,

  • Meeting the demands of process validation Stage 1, which requires assessment of method reliability and performances.

Monitoring CQAs through MAM requires flexible software solutions that cope with these challenges, and also enable reporting on the system suitability and Post-Translational Modifications (PTM) levels, while ensuring high level of compliance and data integrity.

In this webcast learn how scientists at Merck KGaA are routinely performing MAM analyses to: 

  • Study the impact of Critical Process Parameters (CPP) on CQAs

  • Ensure correlation of novel MAM approaches with existing methods while increasing sample throughput by order of magnitude

  • Develop automated workflows that can be performed by operators with little or no MS experience

  • Design an MS-based process validation strategy that addresses dynamic range, sensitivity, precision, and accuracy in accordance with regulatory recommendations 

  • Bring mass spectrometry closer to biopharma quality control by providing the compliance level expected for process validation

 Key Learning Objectives:

  • Learn how automating MAM can dramatically increase productivity in quality monitoring of biopharmaceuticals

  • Learn how biopharma scientists are validating multi-attribute method approaches

  • Learn how knowledge gained throughout a biopharmaceutical’s development can be leveraged to improve product quality

Speakers: Cédric Mesmin, PhD, Mass Spectrometry Specialist/Innovation coordinator, Development-Microbial Unit, Merck Biodevelopment SAS, Martillac, France

Lucie Manache-Alberici, PharmD, Analytical Development Supervisor, Microbial Unit, Merck Biodevelopment SAS, Martillac, France

Jonathan Jones, PhD, Business Development – Expressionist, Genedata Ltd, Cambridge, UK

Time and Date: Tuesday, Jun. 30, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST

Sponsor: Genedata

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