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Mass Spectrometric Approaches to Study Protein Structure and Interactions in Lyophilized Powders
Published on: April 14, 2015
Analytical methods and formulation factors to enhance protein stability in solution
1College of Pharmacy, Dongguk University-Seoul, Gyeonggi 410-820, Korea. shjeong@dongguk.edu
Archives of Pharmacal Research
|December 6, 2012
Summary
Understanding protein degradation pathways and analytical methods is key for developing stable protein formulations. This knowledge helps in selecting excipients to prevent protein instability and improve formulation development efficiency.
Area of Science:
- Biochemistry
- Pharmaceutical Sciences
- Protein Chemistry
Background:
- Stable protein formulations are crucial for therapeutic efficacy.
- Protein degradation mechanisms directly impact formulation stability and shelf-life.
- Intimate knowledge of protein physicochemical properties is essential for successful formulation development.
Purpose of the Study:
- To review major protein degradation pathways and their interactions.
- To discuss analytical methods for detecting protein degradation.
- To present strategies for suppressing protein instability using excipients.
Main Methods:
- Literature review of protein degradation mechanisms.
- Compilation of analytical techniques for protein degradation assessment.
- Summary of formulation strategies and excipient applications.
Main Results:
- Detailed overview of protein degradation pathways.
- Inclusion of various analytical methods for detecting degradation.
- Strategies for stabilizing protein formulations with excipients.
Conclusions:
- Understanding protein degradation is vital for stable formulation development.
- Analytical methods aid in evaluating and ensuring protein stability.
- Effective use of excipients can suppress protein instability, streamlining the development process.
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