Biologics & Pharmaceuticals
SYMBIOSIS offers services ranging from method development and validation to taking on the complete responsibility for release, stability and comparability testing.
Release testing (drug substances and drug products)
All drug products entering the local or worldwide pharmaceutical markets require GMP compliant release testing to meet drug product specifications. SYMBIOSIS performs most required testing in-house. This creates an advantage for our customers by achieving a quick release of their final product.
For a more detailed overview of our expertise please visit our method section. All release-testing packages are customized to your demands.
Certain substances such as antibodies require a comprehensive characterization. In addition to common characterization methods such as chromatography and electrophoresis, we employ advanced analytical techniques like MALDI TOF mass spectrometry and N-terminal sequencing by Edman degradation also in combination with peptide mapping or amino acid analysis.
After changes in the production process of biotechnological products, the comparability according to quality, safety and efficacy of the products before and after the change has to be shown. This is according to ICH Guidance for Industry Q5E.
Every product is analyzed 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 requires extended analytical characterization. For example, in the identification of oxidation, deamidation, carbohydrate linkages or the localization of disulfide bonding. We offer these methods and can 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 our established methods or develop new methods for you. Exemplary methods for such analyses are enzyme-linked immunosorbent assays (ELISA) or RP-HPLC.
Cleaning validation is an important part of process validation. It involves checking the removal of an API by cleaning the manufacturing equipment according to a pre-defined cleaning protocol justifying the chosen content method as sufficient in respect to LOD/LOQ. Prior to cleaning validation, it might be necessary to optimize the LOD/LOQ capacity of the established method for content determination under the cleaning aspects.
We analyse your rinse and swab samples using chromatographic, spectroscopic or titrimetric techniques.