Application Note

Biosimilar Structural Comparison of Commercially Sourced Reference Standards by MMS Rapidly Detects Subtle but Critical Differences to Correctly Predict Activity for Use in an ELISA Product

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Application Note

This Application Note Includes:

  • This study confidently detected <2% structural difference between samples to correctly predict activity amongst the commercially sourced materials.
  • MMS successfully identifies the 5 of 13 BSA biosimilar samples that retained acceptable activity upon inclusion in the ELISA product through structural comparison to a reference of known activity.

It was determined that many of the Bovine Serum Albumin (BSA) reference candidates did not exhibit acceptable activity after inclusion into the final product though all purchased samples shared the same name and identification. The inconsistency in activity causes delays, increases cost of manufacture, and adds an element of variability. Current in-house biophysical techniques fail to correctly identify the inactive candidates prior to product inclusion due to inconclusive results or a lack of sensitivity.  Thus a more accurate, reliable analytical method was sought using MMS. The AQS3pro was able to provide a more detailed analysis and measurements through a simple numerical output reporting the percent similarity of each sample’s spectra relative to the active in-house standard reference was sufficient to correctly identify the active 5 candidates.

Change How You See Biomolecules

Microfluidic Modulation Spectroscopy provides a powerful alternative, producing consistently reproducible data that goes beyond that supplied by current techniques. The high-performance fully automated AQS3pro system and AQS3delta analytics package allow scientists to quickly and easily run samples, process data and gain insight.


Next generation in protein structure determination.

The AQS³pro powered by Microfluidic Modulation Spectroscopy is the next generation infrared based spectroscopy platform for protein structure determination. It represents a novel tool that will strengthen you bioanalytical tool kit and provide critical insights into protein based drug development.
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