Analytical Artifacts in characterization of recombinant monoclonal antibody therapeutics

Publication date: Available online 25 January 2020Source: Journal of Pharmaceutical and Biomedical AnalysisAuthor(s): Dongdong Wang, Christine Nowak, Bruce Mason, Amit Katiyar, Hongcheng LiuAbstractA battery of analytical methods is used to analyze recombinant monoclonal antibodies for lot release to ensure consistent product quality, safety, and efficacy. Additionally, state-of-the-art analytical methods have been used to thoroughly characterize various post-translational modifications and degradation pathways of those molecules. Scientifically sound and robust analytical methods are essential to providing reliable results for defining control strategy, including setting phase-appropriate specifications. Analytical artifacts can substantially impact analytical method performance, causing either overestimation or underestimation of the impacted attributes. However, these artifacts are often overlooked due to lack of the fundamental understanding of analytical methods. This review discusses several regularly encountered artifacts and provides a guidance on assessment and prevention of these artifacts. Understanding and preventing artifacts can help establish scientifically sound and robust methods with reliable performance throughout the method life cycle.
Source: Journal of Pharmaceutical and Biomedical Analysis - Category: Drugs & Pharmacology Source Type: research