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Technical Decision Making With Higher Order Structure Data: Perspectives on Higher Order Structure Characterization
William F Weiss1, John P Gabrielson2, Wasfi Al-Azzam3
1Biopharmaceutical Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285.
Journal of Pharmaceutical Sciences
|October 17, 2016
Summary
Developing a robust higher order structure (HOS) characterization strategy is crucial for biopharmaceutical development. This commentary guides the implementation of comprehensive HOS strategies and industry-academia partnerships for consistent application.
Area of Science:
- Biopharmaceutical Development
- Protein Chemistry
- Analytical Chemistry
Background:
- Characterizing higher order structure (HOS) is vital for protein-based biopharmaceuticals.
- Current approaches and decision-making for HOS characterization during commercialization lack consensus.
- Variability exists in applying biophysical methods and interpreting data.
Purpose of the Study:
- To provide guidance on developing and implementing robust HOS characterization strategies.
- To address the need for consistency in HOS assessment across the biopharmaceutical industry.
- To explore collaborative models for advancing HOS characterization.
Main Methods:
- Review of current practices in HOS characterization.
- Discussion of key concepts for strategy development tailored to specific biologics.
- Exploration of industry-academia-government partnerships.
Main Results:
- Identified key considerations for tailoring HOS strategies to individual biologics.
- Highlighted the importance of inter-sectoral collaboration for improved consistency.
- Proposed a framework for comprehensive HOS characterization.
Conclusions:
- A well-defined HOS characterization strategy is essential for successful biopharmaceutical development.
- Collaboration among stakeholders can enhance the reliability and consistency of HOS data.
- Implementing comprehensive strategies ensures product quality and regulatory compliance.
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