Manufacturing and quality
Fermentation, purification and quality control in Nanjing's Jiangbei New District. Facility visits are welcome.
Quality
Quality from day one
Since its founding Cellnuo has treated product quality as the life of the company. Quality management follows ISO 9001 and GMP requirements.
Drug development to ICH
Medicines in development follow ICH guidelines, across the whole life cycle: development, technology transfer, commercial production and withdrawal.
No animal-derived materials
Recombinant production: no animal-derived raw materials and no risk of outside viruses.
Documents with every product
Test methods, batch documents and regulatory support documents, and a DMF where the product needs one.