Publications by authors named "M J Gnoth"
Following up on our most recent discussion paper focusing 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.
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- 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 Synopsis
- The bioanalytical community traditionally uses blank matrices from preclinical animals for method validation, as required by guidelines, but this practice is increasingly being questioned.
- Despite scientific support for using surrogate matrices instead, regulatory bodies remain hesitant to accept them for most cases, only allowing them for rare situations.
- The European Bioanalysis Forum is advocating for the broader acceptance of surrogate matrices, emphasizing ethical considerations and the need for continued discussions, backed by new experimental data.
Article Synopsis
- * To address these ambiguities, the European Bioanalysis Forum held a workshop in November 2023 in Barcelona to discuss the problematic areas identified by their community and attendees.
- * The manuscript reports the workshop outcomes and offers recommendations to foster ongoing dialogue between the industry and health authorities, promoting a science-driven approach to improve global harmonization in developing quality medicines.
The use of LC-MS(/MS) assays to quantify (biotherapeutic or biomarker) proteins is commonplace and well accepted across industry. There is a good understanding on the added value over conventional analytical technologies (i.e.
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