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

APPLICATION NOTE

This Application Note Includes:

• Microfluidic Modulation Spectroscopy (MMS) as a tool that measures differences in secondary structure of <2% between samples due to highly reproducible replicate measurements generated by the AQS³®pro.
• The power of MMS to predict the relative order of sample stability based on very small secondary structure differences detected between sample pairs of biosimilar molecules incubated at 4°C and 30°C for 8 weeks.

Biosimilar Structure Analysis And Stability Predictions

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.