Assessment of Statistical Significance of minor Changes in HOS Using Circular Dichroism - A New Approach

During development of biosimilars and innovator biotherapeutics the importance of detecting minor changes in higher order structure (HOS) is well recognized. Increasing demands from regulatory authorities for objective, statistically-validatable data presents a challenge for certain data-types including circular dichroism (CD) data. This application note presents results from subjecting an IgG1 to a range of degradation conditions, comparing the resulting CD spectra followed by a rigorous statistical analysis. The significance of the differences between the datasets can be objectively evaluated leading to stronger regulatory submissions.