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LERLIC-MS/MS for In-depth Characterization and Quantification of Glutamine and Asparagine Deamidation in Shotgun Proteomics
Published on: April 9, 2017
Deamidation: a source of microheterogeneity in pharmaceutical proteins
1Division of Biochemistry and Biophysics, Food and Drug Administration, Bethesda, MD 20892.
Trends in Biotechnology
|October 1, 1992
Summary
Protein deamidation occurs naturally and during pharmaceutical manufacturing. This process creates microheterogeneity, impacting drug quality and requiring attention from manufacturers and regulatory agencies.
Area of Science:
- Biochemistry
- Pharmaceutical Science
- Protein Chemistry
Background:
- Spontaneous deamidation is a common post-translational modification in proteins in vivo.
- Deamidation can also occur during pharmaceutical protein production, purification, formulation, and storage.
- This process contributes to protein microheterogeneity, affecting drug product quality.
Purpose of the Study:
- To provide an overview of the scientific and regulatory considerations of protein deamidation.
- To highlight the significance of deamidation as a source of microheterogeneity in pharmaceutical proteins.
- To emphasize the need for addressing deamidation by both manufacturers and regulatory bodies.
Main Methods:
- Literature review of scientific data on protein deamidation.
- Analysis of regulatory guidelines and concerns related to protein modifications.
- Synthesis of information on the impact of deamidation on pharmaceutical protein quality.
Main Results:
- Deamidation is an inherent process affecting protein integrity.
- Microheterogeneity arising from deamidation poses challenges for pharmaceutical product consistency.
- Both scientific understanding and regulatory oversight are crucial for managing deamidation.
Conclusions:
- Deamidation is a critical factor in pharmaceutical protein stability and quality.
- Addressing deamidation requires a collaborative approach between industry and regulatory agencies.
- Further research and standardized methods are needed to control and monitor deamidation.
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