Analytical Department, BioAnalytix, Inc., Memorial Drive, Cambridge, MA, United States.
Product Characterization, Alexion Pharm. Inc., 100 College Street, New Haven, CT, United States.
J Pharm Biomed Anal. 2020 May 10;183:113131. doi: 10.1016/j.jpba.2020.113131. Epub 2020 Jan 25.
A 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.
一系列分析方法被用于分析重组单克隆抗体的放行批，以确保产品质量、安全性和疗效的一致性。此外，还采用了最先进的分析方法对这些分子的各种翻译后修饰和降解途径进行了深入的表征。科学合理且稳健的分析方法对于提供可靠的控制策略结果至关重要，包括设定适当的阶段性规格。分析伪影会严重影响分析方法的性能，导致受影响属性的高估或低估。然而，由于缺乏对分析方法的基本理解，这些伪影往往被忽视。本文讨论了几种常见的伪影，并提供了评估和预防这些伪影的指南。了解和预防伪影有助于在整个方法生命周期内建立科学合理且稳健的方法，并确保其可靠的性能。
