AI Article Synopsis
- The European Bioanalysis Forum has released new insights on the regulatory challenges in bioanalysis using LC-MS/MS for biotherapeutic and biomarker proteins, following their recent discussions.
- The findings are presented in two research papers: one covering the fundamental principles of the technology and the other focusing on practical method development.
- The papers aim to clarify why bioanalysis of biotherapeutic and biomarker proteins is different from traditional LC-MS/MS assays used for small molecules or ligand binding assays for biotherapeutics.
Article Abstract
Following up on our most recent discussion paper focussing on the continued regulatory challenges for bioanalysis of biotherapeutic and biomarker proteins with LC-MS/MS, the European Bioanalysis Forum reports back on their internal discussions on and experience with method development for biotherapeutic and biomarker proteins in research and regulated Bioanalysis. Due to the broad array of topics discussed, this information is spread over two research papers, where one focusses on the fundamental principles on which the technology is built (i.e., the what) and another on the practical considerations (i.e., the how). In this paper, we discuss 'the how'. Both papers should be helpful for the bioanalytical community to better understand the challenges and provide an insight on why bioanalysis of biotherapeutic and biomarker proteins with LC-MS/MS should not be compared with the more traditional LC-MS/MS assay for small molecules or ligand binding assays for biotherapeutics.
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| http://dx.doi.org/10.1080/17576180.2024.2418251 | DOI Listing |
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