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Introduction

Results: HOS analysis possible in a highly absorbing, ‘CD-active’ formulation buffer Methods

During biotherapeutic development a wide range of biophysical

characterization techniques are required to support informed decision

making and contribute to the totality of evidence in regulatory sub

missions. Regulatory authorities are increasing their demand for

‘state-of-the-art’ techniques that can provide statistically-validatable

data. To date, obtaining such results for higher order structure (HOS)

comparisons has presented challenges in terms of data acquisition

and suitability of statistical methods.

Here we present a novel, integrated approach to HOS analysis to

generate an objective, quantifiable comparison of a commercially

available biotherapeutic (Fab fragment) with a biosimilar currently

under development.

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