Characterisation & comparability
Certain substances such as antibodies require a comprehensive characterisation. In addition to common characterisation methods such as chromatography and electrophoresis, we employ advanced analytical techniques like MALDI TOF mass spectrometry and N-terminal sequencing by Edman degradation, possible in combination with peptide mapping.
Any changes to the production process of biotechnological products require a comparability assessment. The quality, safety, and efficacy of the product before and after the change must be shown to be equivalent. This aligns with the ICH Guidance for Industry Q5E.
Every product is analysed for release with an appropriate set of methods to characterize the physicochemical properties and the biological activity. However, the complexity of proteins, polypeptides and their derivatives require extended analytical characterisation. For this purpose, we offer identification of oxidation, deamidation, carbohydrate linkages or the localization of disulfide bonding to support your comparability program.
Impurities and contaminants
Prior to testing for product and process-related impurities and contaminants (according to ICH Guidelines Q3A and Q3B) it is necessary to establish and validate suitable methods. We can provide established methods or develop new methods specifically for you. Exemplary methods for such analyses are enzyme-linked immunosorbent assays (ELISA) or RP-HPLC.
Cleaning validation
Cleaning validation is an essential part of process validation. It confirms that the active ingredient (API) is effectively removed from manufacturing equipment by following a predefined cleaning protocol. The selected analytical method must be justified as sufficiently sensitive, particularly regarding its LOD and LOQ. Before performing cleaning validation, it may be necessary to optimize the method’s LOD/LOQ to ensure it is suitable for detecting residues under cleaning conditions.
We analyse your rinse and swab samples using chromatographic, spectroscopic or titrimetric techniques.
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