Browsing: regulatory

Features antibodies-702x336

In this series we will be discovering what immunogenicity is, why it is important and how is it regulated and standardized.

Regulated Bioanalysis

The purpose of this paper is to describe validation experiments that measure immunocapture efficiency, digestion efficiency, matrix effect and selectivity/specificity that can be used during method optimization and validation to test the resistance of the method to these potential interferences. The designs and benefits of these experiments are discussed in this report using an actual assay case study.

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