Monitoring modifications in biopharmaceuticals: Toolbox for a generic and robust high-throughput quantification method

• Published in: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Analytical technologies in the biomedical and life sciences, 2020-07, Vol.1148, p.122134-122134, Article 122134
• Main Authors: Bauer, Ludwig Gerhard, Hoelterhoff, Sina, Graf, Tobias, Bell, Christian, Bathke, Anja
• Format: Article
• Language: English
• ISSN: 1570-0232; 1873-376X
• DOI: 10.1016/j.jchromb.2020.122134

•Generic and robust high-throughput peptide mapping method.•Toolbox for different approaches of peptide mapping.•Automatic sample preparation by a pipetting robot.•Quantification of PTMs by using a Single Quad LC-MS system. Monoclonal antibodies (mAbs) constitute one of the most important and fastest growing sector within the pharmaceutical industry. The variety of different formats and the large molecule sizes of the mAbs result in an inherent complexity. In addition, the posttranslational modifications (PTMs) that can occur during production, formulation and storage pose a major analytical challenge for their characterization. These PTMs may affect the safety, efficacy and/or pharmacokinetic profile of the medicinal product. Therefore, strict quality and stability monitoring, in particular of (potentially) critical quality attributes (CQAs), is mandatory. Focusing on these needs, a toolbox for different approaches of peptide mapping in the routine quality control (QC) environment was developed. This toolbox includes an automated sample preparation with an optimized buffer system in combination with a Single Quad LC-MS system, which provides the flexibility to handle a high-throughput workflow. Our results demonstrate that a Single Quad LC-MS system is suitable for a routine work environment to monitor modifications by using a user-friendly system.