In addition to deducing the primary structure and any Post-Translational Modifications (PTMs) associated with your molecule, the regulators also require a full understanding of the higher order shape and structure. Biosimilars must be shown to be similar to the originator molecule, in terms of their secondary and tertiary structure and levels of aggregation. This is achieved by performing comparability studies with your biosimilar and a range of different originator batches.
As part of BioPharmaSpec’s core analytical services, we provide a range of techniques aimed at addressing the challenges associated with higher order structure determination. The regulators (e.g. the US FDA and EMA) recommend that you analyze your product according to ICH Q6B, which includes requirements for investigating Biophysical and Physicochemical properties. In this poster we describe the importance of these Physicochemical and Biophysical techniques and present data obtained from each method.
