Measurements

Similarity

For biosimilar molecules and reference standards, similarity in safety and efficacy is a must. Similarity in structure is also a requirement to guarantee critical quality characteristics. By using Microfluidic Modulation Spectroscopy (MMS) to measure and compare the similarity of a biosimilar or generic molecule against a known innovator or standard molecule, it is possible to quickly qualify how similar they are and characterize the differences in structure. This is accomplished through the relationship of the similarity measurement to the four additional measurements that are performed for each sample analysis. The relative similarity to a designated molecule as determined through area of overlap is calculated in percent form, making the identification of outliers and non-conforming molecules obvious.

As the relationship of structure vs function is determined for all biomolecules within the development and formulation pipelines, it is increasingly important to be confident in the critical quality attributes that govern their performance. Through incorporation of MMS into the characterization workflow and the use of a high-powered quantum cascade laser and optimized detector, the AQS³pro can detect differences in structural similarity at levels as low as 2%.

Second derivative spectral overlay of several insulin biosimilar molecules as part of long-term storage stability study at 4˚C and 30˚C. Application Note Biosimilar Structural comparison of Commercially Source Reference Standards by MMS Rapidly Detects Subtle but Critical Differences to Correctly Predict Activity for Use in an ELISA Product.

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