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Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
Published on: December 1, 2020
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Overview on biotherapeutic proteins: impact on bioanalysis
Yan J Zhang1, Linlin Luo1, Dharmesh D Desai1
1Analytical & Bioanalytical Development, Bioanalytical Sciences-Biologics, Bristol-Myers Squibb, NJ, USA.
Bioanalysis
|December 10, 2015
Summary
Designing bioanalytical strategies for protein therapeutics requires understanding protein types, modifications, and formulation. This overview guides strategy development for nonclinical and clinical studies, considering pharmacokinetics and immunogenicity.
Area of Science:
- Biopharmaceutical Analysis
- Drug Development Science
- Protein Therapeutics Bioanalysis
Background:
- Designing bioanalytical strategies is crucial for in vivo studies of protein therapeutics.
- Understanding therapeutic protein characteristics is essential for accurate assessment.
- Factors like post-translational modifications and formulation impact protein behavior and analysis.
Purpose of the Study:
- To provide an overview of information and factors for designing bioanalytical strategies for protein therapeutics.
- To highlight the influence of various protein attributes on bioanalytical approaches.
- To discuss the impact of structural variants and protein forms on pharmacokinetic assessments.
Main Methods:
- Literature review and synthesis of information relevant to protein therapeutic bioanalysis.
- Discussion of key factors including protein types, structural characteristics, and post-translational modifications.
- Analysis of purification, formulation, pharmacokinetics, and immunogenicity considerations.
Main Results:
- Identified key factors influencing bioanalytical strategy design for protein therapeutics.
- Detailed the relationship between protein properties (e.g., PTMs, structure) and bioanalytical requirements.
- Highlighted the impact of structural variants and 'free'/'bound' forms on pharmacokinetic assessment.
Conclusions:
- Effective bioanalytical strategies for protein therapeutics necessitate a comprehensive understanding of the drug substance.
- Consideration of protein characteristics, formulation, and potential biological interactions is vital.
- This overview serves as a guide for optimizing bioanalytical approaches in drug development.
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