Analysis of Deamidation Artifacts Induced by Microwave-Assisted Tryptic Digestion of a Monoclonal Antibody

Published

July 31, 2014

Author(s)

Catherine A. Mouchahoir, Nathanael A. Heckert, Karen W. Phinney

Abstract

The thorough characterization of biopharmaceuticals is essential for ensuring their quality and safety, since many potential variations can cause changes to a drug’s properties that may be detrimental to the patient. Prior to approval and release, protein-based drugs are subject to a battery of analyses to assess the nature of many critical quality attributes. In some cases the analytical method used may cause modifications that are difficult to distinguish from those inherent to the drug itself. It is therefore important to develop and utilize analytical methods which impose as little artifactual modifications as possible. Here we examine whether microwave assisted tryptic digestion promotes higher levels of asparagine deamidation as compared to alternate digestion methods.

Citation

Analytical and Bioanalytical Chemistry

Pub Type

Journals

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DOI Link

Keywords

Biopharmaceutical degradation, monoclonal antibody, asparagine deamidation, tryptic digestion, microwave assisted hydrolysis

Citation

Mouchahoir, C. , Heckert, N. and Phinney, K. (2014), Analysis of Deamidation Artifacts Induced by Microwave-Assisted Tryptic Digestion of a Monoclonal Antibody, Analytical and Bioanalytical Chemistry, [online], https://doi.org/10.1007/s00216-014-8043-x (Accessed April 25, 2024)