REGULATED BIOANALYSIS: FUNDAMENTALS AND PRACTICE

Johanna Mora, Charles Hottenstein, Binodh DeSilva
Regulated Bioanalysis: Fundamentals and Practice 

Volume 26 of the series AAPS Advances in the Pharmaceutical Sciences series

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Abstract:

This chapter covers the use of ligand binding assays (LBAs) in a regulated bioanalysis environment. The various platforms employed in the analysis of protein therapeutics are varied and selection of the appropriate platform for a particular application is highlighted. The suitability, procurement and implementation of critical reagents are of major importance for LBAs and considerations for their careful selection and use are provided. In addition, various strategies, including Design of Experiments (DoE) are discussed as a means of optimizing assay conditions to produce robust and rugged assays during method development. The key parameters for the validation of LBAs are discussed in depth as well as many considerations, including automation, that can be employed when analyzing study samples in a production environment.