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Analyzing Polysorbates
By Mass Spectrometry

Genedata Expressionist Software Solutions for MS-Based Contaminant Detection: Focus on Polysorbates

Journal of Pharmaceutical Sciences Publication

Although widely used as excipients in biotherapeutic formulations, polysorbates such as PS20 and PS80 may degrade through oxidation or hydrolysis, generating molecular species that can affect the quality, efficacy, safety, and stability of biopharmaceuticals. Consequently, identifying and characterizing polysorbate degradation is key to developing and commercializing therapeutic protein products.

By delivering information-rich data at the molecular level, mass spectrometry offers a powerful approach to overcome the challenges of analyzing these complex and heterogeneous molecules. However, evaluation of the large volumes of highly complex MS data obtained from samples containing polysorbates typically requires laborious and time-consuming expert analysis.

Discover how our partners at Merck Inc. overcame the key challenges of MS-based PS-80 characterization
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ASMS 2022 Poster

Here we present a method for the detailed analysis of PS-80 components using Reversed-Phase Ultra High-Performance Liquid Chromatography coupled with High Resolution Mass Spectrometry (RP-UHPLC-HRMS) utilizing post-column charge reduction and a dedicated software workflow for an uncompromising increase in robustness and reduction in analysis time.

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ChallengeGenedata Expressionist Solution
Molecular complexity and coeluting speciesAdvanced visualizations enabling intuitive and in-depth characterization
Laborious manual processing of large volumes of complex dataFully automatable workflows for MS data processing, analysis, and reporting implemented on a scalable software platform
Unambiguous identification of highly heterogenous speciesCustom-built libraries enabling high-confidence identification and creation of a corporate contaminant knowledge base
Intuitive Genedata Expressionist visualizations such as the two-dimensional ion map (left) and 3D display (right) facilitate identification of coeluting polysorbate species

Discover Genedata Expressionist Solutions for MS Data Processing, Analysis, & Reporting

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