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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars
Steven A Berkowitz1, John R Engen, Jeffrey R Mazzeo
1Analytical Development, Biogen Idec, 14 Cambridge Center, Cambridge, Massachusetts 02142, USA.
Nature Reviews. Drug Discovery
|June 30, 2012
Summary
Analytical technologies are crucial for evaluating biosimilar protein biopharmaceuticals. This review covers methods for assessing critical quality attributes like post-translational modifications, 3D structures, and aggregation for biosimilar development.
Area of Science:
- Biopharmaceutical development
- Analytical chemistry
- Regulatory science
Background:
- Biologics, like monoclonal antibodies, are complex protein-based drugs.
- Follow-on versions, known as biosimilars, face development and regulatory challenges.
- Analytical technologies are key to comparing biosimilars to reference products.
Purpose of the Study:
- To review the current state of analytical technologies for biosimilar evaluation.
- To focus on critical quality attributes identified by regulatory authorities.
- To discuss methods for assessing post-translational modifications, 3D structures, and protein aggregation.
Main Methods:
- Review of current analytical technologies.
- Focus on methods applicable to protein biopharmaceuticals.
- Assessment of techniques for specific quality attributes.
Main Results:
- Analytical technologies play a vital role in biosimilar development.
- Key characteristics for comparison include post-translational modifications, 3D structure, and aggregation.
- The state of the art in analytical methods for these attributes is discussed.
Conclusions:
- Advanced analytical techniques are essential for establishing biosimilarity.
- Regulatory authorities emphasize specific quality attributes for biosimilar assessment.
- Continued development of analytical technologies will support biosimilar regulatory pathways.
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