Multi-Attribute Method for Quality Control of Therapeutic Proteins

被引:89
作者
Rogstad, Sarah [1 ]
Yan, Haoheng [2 ]
Wang, Xiaoshi [2 ]
Powers, David [2 ]
Brorson, Kurt [2 ,3 ]
Damdinsuren, Bazarragchaa [2 ]
Lee, Sau [1 ]
机构
[1] US FDA, Off Testing & Res, Off Pharmaceut Qual, CDER, Silver Spring, MD 20993 USA
[2] US FDA, Off Biotechnol Prod, Off Pharmaceut Qual, CDER, Silver Spring, MD 20993 USA
[3] PAREXEL Int, Bethesda, MD 20814 USA
关键词
MASS-SPECTROMETRY; MONOCLONAL-ANTIBODY; GLYCOSYLATION;
D O I
10.1021/acs.analchem.9b03808
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
Recent advances in high resolution mass spectrometry (MS) instrumentation and semi-automated software have led to a push toward the use of MS-based methods for quality control (QC) testing of therapeutic proteins in a cGMP environment. The approach that is most commonly being proposed for this purpose is known as the multi-attribute method (MAM). MAM is a promising approach that provides some distinct benefits compared to conventional methods currently used for QC testing of protein therapeutics, such as CEX, HILIC, and CE-SDS. Because MS-based methods have not been regularly used in this context in the past, new scientific and regulatory questions should be addressed prior to the final stages of implementation. We have categorized these questions into four major aspects for MAM implementation in a cGMP environment for both new and existing products: risk assessment, method validation, capabilities and specificities of the New Peak Detection (NPD) feature, and comparisons to conventional methods. This perspective outlines considerations for each of these main points and suggests approaches to help address potential issues.
引用
收藏
页码:14170 / 14177
页数:8
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