Analytic of proteinogenic drugs
Characterization of proteinogenic drugs is an essential aspect of quality control of new biopharmaceuticals, starting from development up to production of approved drugs. The pharmacopoeias allow a wide range of methods for this purpose, primarily using HPLC/UPLC-based methods with different detectors such as UV/Vis, fluorescence or mass spectrometric detectors.
GBA Pharma Labs offers a wide range of methods based on the latest HPLC/UPLC systems with various detection systems, as well as capillary electrophoresis. For mass spectrometric characterizations, the Orbitrap Exploris system from ThermoFisher Scientific is available qualified under GMP conditions.
The following parameters can be analyzed at our laboratories:
- Peptide mapping
- Amino acid sequence determination
- High-resolution mass determination of proteins and peptides
- Qualitative and quantitative determination of posttranslational modifications such as oxidation methionine
- Qualitative and quantitative analysis of glycans
- Determination of aggregates
- Determination of charge variants