Category: Manufacturing and Bioprocessing
Purpose: The purpose of this poster and work is to demonstrate how the incorporation of orthogonal mass detection and the use of multi-attribute monitoring (MAM) can streamline data capture and build process and method understanding in support of accelerated process development and method development/transfer.
Methods: A LC-MS peptide mapping based multi-attribute monitoring method is run and results are shown.
Results: 16 product attributes are simultaneously monitored using a Peptide-MAM workflow run under Empower Chromatography Data Software (CDS) with the ACQUITY QDa mass detector. Results show relative quantification of native versus glycosylated, oxidatized, deamidated and other variant forms of target peptides, as well as standard deviation results across multiple injections, demonstrating a high degree of assay repeatability and repdroducibility.
Conclusion: Collectively, this user case demonstrates how Empower’s integrated features can be used to streamline MAM-based workflows through visualization and data management and help reduce some of the burden associated with the deployment and migration of methods from process development to manufacturing and QC lot release through:
Joe Fredette– Business Development Manager, Waters Corporation, Milford, Massachusetts
Robert Birdsall– Principle Scientist, Waters Corporation, Milford, Massachusetts
Weibin Chen– Milford, Massachusetts
Ying Qing Yu– Senior Science Manager, Waters Corporation, Milford, Massachusetts
Ximo Zhang– Milford, Massachusetts