Overview on biotherapeutic proteins: impact on bioanalysis
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Updated: Mar 29, 2026

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
Published on: December 1, 2020
Yan J Zhang1, Linlin Luo1, Dharmesh D Desai1
1Analytical & Bioanalytical Development, Bioanalytical Sciences-Biologics, Bristol-Myers Squibb, NJ, USA.
Abstract:
This article provides an overview of the information and factors relevant to designing bioanalytical strategies in support of in vivo nonclinical and clinical studies of protein therapeutics. The summarized information includes representative types of the therapeutic proteins, their key structural characteristics, the relationship between post-translational modifications and function, issues during purification and formulation, PK of therapeutic proteins and immunogenicity. The effect of each of those on bioanalysis strategy has been pointed out. The impacts of structural variant and 'free'/'bound' forms on PK assessment have been discussed.
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