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The Analytical Scientist: HOS analysis in the biopharmaceutical industry

September 3, 2020

Infrared spectroscopy is a useful technique for higher order structure analysis in the biopharmaceutical industry, but conventional systems lack pace and performance. It’s time for Microfluidic Modulation Spectroscopy.

Jeff Zonderman | Opinion

The bar is rising for analytical techniques in the biopharmaceutical industry. Data quality used to be the only deciding factor, but other issues are now weighing in – notably, ease of use. Usability is becoming a defining characteristic of analytical tools for biotherapeutics labs looking to do more with less against aggressive timelines. As workflows are refined to maximize information flow, high-throughput systems with automated data acquisition and processing are becoming increasingly desirable. There is a great (and growing) appetite for innovative technologies that can serve this purpose across the biopharmaceutical lifecycle.

Higher order structure (HOS) analysis is crucial in biopharmaceutical development and commercial manufacture; such measurements characterize the secondary, tertiary, and quaternary folding and spatial arrangements that define the three-dimensional shape and interactions of biotherapeutic molecules. Those with a basic grounding in biology will know that changes in HOS impact functionality – and for biopharmaceuticals that can trigger loss of stability, increased aggregation, compromised efficacy, and increased immunogenicity. In short, quantifying and monitoring HOS across biopharmaceutical development and commercial manufacture is critical to understand, identify, and maintain conditions that will reliably deliver a safe and efficacious drug.

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