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Published on: May 4, 2017
Analytical lessons learned from selected therapeutic protein drug comparability studies
Marcia Federici1, Anthony Lubiniecki, Prakash Manikwar
1Biotechnology Consulting, 101 Summit Road, Springfield, PA 19064, USA. marymarfed@comcast.net
Summary
Ensuring therapeutic protein drug quality requires comparability studies to assess process changes. Analytical methods are key to evaluating structural and functional impacts for product safety and efficacy.
Area of Science:
- Biochemistry
- Pharmaceutical Sciences
- Analytical Chemistry
Background:
- Therapeutic protein drugs require rigorous quality assessment during development and post-commercialization.
- Process and product modifications necessitate detailed evaluation of their impact on protein structure and biological function.
- Comparability exercises are crucial for ensuring the consistency and safety of therapeutic proteins.
Purpose of the Study:
- To review analytical results and lessons learned from published therapeutic protein comparability case studies.
- To provide an overview of current and emerging analytical methodologies for comparability assessments.
- To discuss novel analytical approaches for evaluating protein drug stability, structure, and degradation.
Main Methods:
- Review of published therapeutic protein comparability case studies.
- Analysis of established analytical methodologies for biochemical and biological characterization.
- Exploration of novel techniques such as hydrogen/deuterium exchange mass spectrometry and 2D NMR fingerprinting.
- Presentation of new methods for detecting and characterizing protein aggregates and particles.
Main Results:
- Case studies highlight the importance of analytical data in assessing comparability.
- Current analytical techniques provide a robust framework for comparability exercises.
- Emerging analytical methods offer enhanced capabilities for characterizing higher-order structure and degradation products.
- Improved detection and characterization of protein aggregates and particles are critical for product quality.
Conclusions:
- Analytical methodologies are indispensable for elucidating structure-function relationships in therapeutic proteins.
- A comprehensive suite of analytical techniques is essential for robust comparability assessments.
- Novel analytical approaches enhance the evaluation of therapeutic protein quality and stability.
- Understanding and controlling protein aggregation and particle formation are paramount for ensuring product safety and efficacy.
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