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Keeping up with New Emerging Analytical Technology

Explore advancements in emerging analytical technologies like Process Analytical Technology (PAT) and mass spectrometry, improving drug development through enhanced bioprocess monitoring and control.

Liquid chromatography-mass spectrometry (LC-MS) is used in various applications across the biotherapeutic protein manufacturing workflow pertaining to drug product quality. Mass spectrometry-based applications range from evaluating glycan distributions in monoclonal antibody products to optimization of the cell culture process development by monitoring amino acid and metabolite consumption. Given its analytical flexibility, LC-MS has the capacity to address complex questions; however, LC-MS instrumentation requires a high level of technical experience and more method development than other analytical procedures. Additionally, media development and feed studies in cell culture process optimization are labor-intensive and time-consuming. There is a growing interest in implementing efficient and simplified methods for cell culture media analysis to push for faster innovative processes in biomanufacturing. Newer analytical equipment does not attempt to address the complexity of LC-MS applications specifically targeted for high throughput media analysis of cell culture. This capillary electrophoresis-mass spectrometry (CE-MS)-based Amino Acid Analyzer is a device with simple procedures that provide a similar ability to the traditional LC-MS to specifically identify and quantitate an array of amino acids and several other important metabolites while providing a user-friendly interface and process.

  • Ascertain the capabilities and limitations of the Amino Acid Analyzer.
  • Compare the Amino Acid Analyzer, a new generation of CE-MS analytical platform, against traditional LC-MS methods.
  • Evaluate the data quality, trade-offs in operation, and resourcefulness of the analytical platforms.

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