We offer a wide range of services and techniques that enable the analysis of the profile of process-related impurities of biotechnological products in accordance with the requirements of the ICH Q6B guideline.
Our offer includes determination and research of process-related impurities:
- originating from cells:
– host proteins,
– nucleic acids (genome, vector or complete DNA),
- originating from cell cultures:
– chemical reagents,
– inorganic salts (heavy metals, arsenic, non-metallic ions),