Strategy for peptide quantification using LC–MS in regulated bioanalysis: case study with a glucose-responsive insulin
| Autor: | Helengrace Schuck, Sheila Breidinger, Kenneth Willson, Yang Xu, Eric Woolf, Tonya Jackson, Dina Goykhman, Jane Harrelson, Ming Wang, Iris Xie |
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| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Bioanalysis medicine.medical_treatment Clinical Biochemistry Insulins 01 natural sciences Glucose responsive Chromatography Affinity Analytical Chemistry 03 medical and health sciences Dogs Limit of Detection Tandem Mass Spectrometry Liquid chromatography–mass spectrometry medicine Animals Humans Insulin General Pharmacology Toxicology and Pharmaceutics Chromatography High Pressure Liquid Chromatography Chemistry Insulin Short-Acting Solid Phase Extraction 010401 analytical chemistry Antibodies Monoclonal Reproducibility of Results Peptide quantification General Medicine Assay sensitivity Rats 0104 chemical sciences Insulin Long-Acting Medical Laboratory Technology 030104 developmental biology Peptides Half-Life |
| Zdroj: | Bioanalysis. 10:1207-1220 |
| ISSN: | 1757-6199 1757-6180 |
| Popis: | Aim: Advances in technology have led to a shift for peptide quantification from traditional ligand-binding assays to LC–MS/MS-based analysis, which presents challenges, in other assay sensitivity, specificity and ruggedness, in addition to lacking of regulatory guidance, especially for the hybrid assay format. Methodology & results: This report communicates a strategy that has been employed in our laboratories for method development and assay validation, and exemplified in a case study of MK-2640, a glucose-responsive insulin, in multiple matrices. Intact MK-2640 was monitored, while immunoaffinity purification and SPE were used to support the rat/dog GLP and clinical studies, respectively. The rationale and considerations behind our approach, as well as the acceptance criteria applied to the assay validation are discussed. |
| Databáze: | OpenAIRE |
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