Confident Differentiation of <2% changes in Secondary Structure to Compare Batch-to-Batch Activity using Microfluidic Modulation Spectroscopy (MMS)

Dr. Patrick King & Dr. Mike Williams - RedShiftBio
Susana De Jesús Acosta, Dr. Roser Llevadot - BioKit

Microfluidic Modulation Spectroscopy (MMS) is a revolutionary new fully-automated infra-red technology that measures protein secondary structure across a wider concentration range than traditional spectroscopy techniques (0.1 to >200 mg/ml), and is compatible with the majority of complex biological buffers and excipients such as DMSO, Serum, excipients, reducing agents, adjuvants, surfactants and carbohydrates. Exhibiting exceptional spectral reproducibility (>98.5% at 0.1 mg/ml), MMS enables small but critical changes in structure to be confidently differentiated, providing accurate measurement of structural differences that may have an impact on function. Here <2% differences in four types of secondary structure were used to correctly predict which of 13 BSA samples from different suppliers and batches would be viable in activity for an ELISA kit product. Of all samples tested, only five were found to be sufficiently active in the kit corresponding to similarity criteria relative to the control. Structural changes of less than 2% are extremely challenging to measure using traditional techniques.