Moving SWATH LC–MS Host Cell Protein Analysis into a GMP Environment?

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Event Overview:

For new biologics under development, validated host cell protein (HCP) impurity assays are needed as a GMP release test to show product purity. Often, the available HCP ELISA assays does not have sufficient HCP coverage for the new manufacturing process, and sometimes it is not possible to develop a product-specific ELISA test. Liquid chromatography–mass spectrometry (LC–MS) has been used as orthogonal method to ELISA to identity and quantify individual and potentially problematic HCPs. However, it has been very difficult to move HCP analysis by LC–MS into quality control (QC) laboratories due to the complexity of the sample preparation and data analysis, the sophistication of the high-end mass spectrometers, and lack of reproducibility of the complete workflow.

At the contract research organization Alphalyse, we have developed a robust and automated workflow based on combining data dependent acquisition and data independent (SWATH™) mass spectrometry and using intact proteins as internal standards for robust and reproducible sample analysis. Using data from multiple projects, we investigated the robustness and reproducibility of the method, over a period of 3 years and on a variety of different projects. All projects here run including the same set of 7 standard proteins as internal standards, making it possible to measure different parameters likely to have an influence on the possibility to transfer the method to GMP level including.

Key Learning Objectives:

• Gain insight to new approaches and methods in LC–MS for robust, streamlined definition of host-cell proteins (HCPs) for GMP release
• Learn about the application of data-independent acquisition (SWATH™) LC–MS as an orthogonal method to ELISA
• Understand how to use (SWATH™)-LC–MS in a quality control environment
• Hear about specific case studies of next generation biotherapeutics NGB characterization from experts in the field

Who Should Attend:

• Scientists, managers or directors who are either involved or interested in next-generation protein therapeutic development

Speakers

Thomas Kofoed, Ph.D.
CEO
Alphalyse

Sponsors

SCIEX

Register Free: http://www.chromatographyonline.com/lcgc_w/gmp