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Monitoring and determining the cause of antibody discoloration

Intabio
22 Jan 2024

Color is a potential critical quality attribute of protein therapeutics. Undesirable color changes can lead to increased product heterogeneity and concerns about the safety and efficacy of a drug. Hence, the cause of color change in biotherapeutics must be fully understood and reported to regulatory agencies.

This technical note highlights a streamlined solution that combines the power of capillary isoelectric focusing (cIEF) to monitor antibody discoloration and an EAD-based MAM workflow to determine the cause of color change. The cIEF profiles of the time-course forced glycation samples of NISTmAb revealed a significant increase in acidic variants in the discolored samples. EAD-based MAM was employed to identify and quantify the acidic species to assess their role in the discoloration of protein therapeutics.

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The Intabio ZT system couples icIEF separation and UV detection with high-resolution mass spectrometry on the ZenoTOF 7600 system. Experience one integrated workflow with a single, accessible dataset containing the required information to make the right decisions, fast.

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Mass SpectrometryMass spectrometry (MS) is a powerful analytical technique used to identify and quantify molecules based on the mass-to-charge ratio of gas-phase ions. It provides detailed information about the structure, composition, and properties of compounds and is widely used across fields such as environmental monitoring, materials science, drug discovery and development, food and beverage testing, and wider chemical research. Key MS techniques include tandem mass spectrometry (MS/MS), liquid chromatography–mass spectrometry (LS-MS) and inductively coupled plasma (ICP-MS). Choosing from these wide range of techniques and technologies can be a daunting task, so keep up to date with scientific applications, performance expectations, and customer reviews here all in one place. Visit our product directory to receive quotes direct from the manufacturer. AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.Cell Lines Stem Cells and Primary CellsPrimary cell cultures, established cell lines and stem cells are vital for <i>in vitro</i> and <i>ex vivo</i> experimentation. High-quality cells, optimized for your applications, alongside optimized cell substrates, growth medium and supplements, are critical for experimental success. Explore a range of cells suitable for your applications, including isogenic cell lines, competent cells, induced pluripotent stem cell (iPSC)-derived cell lines, fungal/bacterial/mammalian cell lines, stem cells and cancer cell lines. Find the best cells for your research in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Antibody ProductionAntibody production is essential for a wide range of applications in biochemistry and immunology. Ensuring high-quality monoclonal and polyclonal antibodies are produced is key. Explore antibody production tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.

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Monitoring and determining the cause of antibody discoloration