Selvita specialists are experienced in validation of bioanalytical methods concerning quantification of biomolecules that are identified as process-related impurities (e.g. HCP, DNA and Protein A).
The set of validated parameters, terms and their definitions are derived from ICH Harmonised Tripartite Guideline – Validation of Analytical Procedures: Text and Methodology. This serves as a guidance and recommendations on how to consider the various validation characteristics for each analytical procedure. The range of our services includes:
Cell substrate-derived impurities, e.g. HCP, DNA, endotoxin
Cell culture-derived impurities, e.g.inducers, antibiotics, media components
Downstream-derived impurities, e.g. heavy metals, preservative agents
Truncated forms, aggregates and modifications (PTM’s)