We offer a number of services and techniques within the scope of analyzing the chromatographic profile of impurities of biotechnological products in accordance with the requirements of the ICH Q6B guideline.
We carry side-by-side comparison of biosimilar products within the scope of stress degradation conditions in accordance with the ICH Q5E guideline such as:
- light exposure,
- increasing/ lowering pH,
- increasing/ lowering temperature,
We use the HPLC, UPLC chromatographs equipped with UV, PDA, MALS, FLR detectors.