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Deamidation Can Compromise Antibody Colloidal Stability and Enhance Aggregation in a pH-Dependent Manner
Magfur E Alam1, Gregory V Barnett2, Thomas R Slaney2
1Isermann Department of Chemical & Biological Engineering, Center for Biotechnology & Interdisciplinary Studies , Rensselaer Polytechnic Institute , Troy , New York 12180 , United States.
Molecular Pharmaceutics
|March 28, 2019
Summary
Chemical modifications like deamidation can negatively impact monoclonal antibody (mAb) physical stability, especially at low pH. Understanding these pH-dependent effects is crucial for developing stable antibody therapeutics.
Area of Science:
- Biopharmaceutical Development
- Protein Chemistry
- Drug Stability
Background:
- Monoclonal antibodies (mAbs) require robust chemical and physical stability for therapeutic applications.
- Limited understanding exists regarding the interplay between chemical modifications and physical stability in mAbs.
Purpose of the Study:
- To investigate the impact of deamidation on the physical stability of monoclonal antibodies across a range of pH values.
- To elucidate the relationship between chemical modification (deamidation) and physical properties (aggregation, self-association) in mAbs.
Main Methods:
- Studied the effect of deamidation on two distinct monoclonal antibodies.
- Evaluated physical stability as a function of pH, specifically from pH 3.8 to 7.4.
- Assessed changes in antibody hydrophobicity and aggregation propensity.
Main Results:
- Deamidation significantly and specifically impacted mAb physical stability at low pH (pH 3.8).
- Observed increased self-association and aggregation of deamidated mAbs at low pH.
- Deamidation-induced increases in hydrophobicity at low pH were identified as a key factor in aggregation.
Conclusions:
- Deamidation exerts pH-dependent effects on the colloidal stability and aggregation of monoclonal antibodies.
- Findings are critical for optimizing the development and manufacturing of stable antibody drugs.
- Understanding chemical modification impacts is essential for producing potent antibody therapeutics.
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