We offer a wide range of services and techniques that enable the analysis of the profile of product-related impurities for biotechnological products in accordance with the requirements of the ICH Q6B guideline.
Our offer includes the analysis and research of:
- ‘truncated’ forms:
– digestion of peptide bonds (hydrolytic enzymes or other reagents),
- products of degradation:
– a disulphide bond mismatch,
– conjugated forms: glycosylation, phosphorylation,
- aggregation (dimers and higher polymers).