Monitoring modifications in biopharmaceuticals: Toolbox for a generic and robust high-throughput quantification method
| Autor: | Ludwig Gerhard Bauer, Anja Bathke, Christian Bell, Tobias Graf, Sina Hoelterhoff |
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| Rok vydání: | 2019 |
| Předmět: |
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Clinical Biochemistry Stability (learning theory) 030226 pharmacology & pharmacy 01 natural sciences Biochemistry Analytical Chemistry 03 medical and health sciences 0302 clinical medicine Quality (business) Throughput (business) Pharmaceutical industry media_common Flexibility (engineering) Chromatography business.industry Chemistry 010401 analytical chemistry Cell Biology General Medicine Toolbox 0104 chemical sciences Workflow Biochemical engineering business Critical quality attributes |
| Zdroj: | Journal of chromatography. B, Analytical technologies in the biomedical and life sciences. 1148 |
| ISSN: | 1873-376X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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