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生物藥**結構相似性分析案例一
日期：2023-01-28 00:34
瀏覽次數：62
摘要：**結構HOS相似性分析方法示例
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.
