Biosimilar Comparison and Accelerated Stability Predictions Based on <2% Secondary Structure Differences Using Microfluidic Modulation Spectroscopy (MMS) Application note

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Biosimilar molecules are designed to mimic innovator molecules that have been approved and are available on the market, providing others within the industry an opportunity to create structurally similar therapeutic medicines for greater patient accessibility. This application note explores the success of Microfluidic Modulation Spectroscopy (MMS) as an automated tool for detecting and differentiating small changes in secondary structure and predicting overall stability of biosimilars for their long-term stability studies.

This study demonstrates that MMS can be used for stability studies due to its ability to detect very small structural changes that are invisible to traditional technologies. Additionally, by using similarity analysis, a simple numerical output was generated by AQS³delta analytics allowing samples to be rapidly compared and ranked for facile interpretation of results. 

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