Establishment of a robust mAb subunit product quality attribute monitoring method suitable for development, process monitoring, and QC release

11 Apr 2021

In this application note, Waters demonstrate the implementation of a subunit MAM method on two additional Tof-based MS systems (BioAccord and Vion) to monitor antibody glycosylation, glycation, oxidation, and sequence variants.

BioAccord LC-MS System

Waters

The First SmartMS-Enabled Biopharma Solution  The Waters BioAccord System is an integrated system that simplifies high performance LC-MS biopharmaceutical analysis for every user. An easy-to-use system solution that puts the power to make decisions directly in your hands; a self-calibrating, self-optimizing, self-sufficient tool that equips you with high quality data you can use to tackle the challenges you face every day during biopharmaceutical development.

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Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.LC-MSLC-MS (liquid chromatography-mass spectrometry) systems and equipment are used for separation and quantitative analysis of complex mixtures, combining liquid chromatography and mass spectrometry. Quantify proteins, contaminants, pesticides or screen for drug metabolites with a high level of sensitivity. LC-MS systems and equipment include reverse phase, normal phase and specialized columns integrated with various MS detectors such as time-of-flight (TOF), quadrupole, orbitrap or ion trap mass analyzers. LC-MS/MS instruments equipped with a qTOF or triple quadrupole analyzer give greater sensitivity and resolving power to your analysis. Find the best LC-MS equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.
Establishment of a robust mAb subunit product quality attribute monitoring method suitable for development, process monitoring, and QC release