Quality systemOur quality system, one of our main concerns
Our focus and rigorous efforts have always served the quality of our services. Through trained and experienced teams, qualified facilities, validated methods and a licensed quality system, we offer services complying with applicable national and international regulatory guidelines.
As pharmaceutical companies, Clean Cells and Naobios own infrastructures which comply with GMP regulatory requirements to perform pharmaceutical operations as requested by our customers.
Our infrastructures consist of Biosafety Level 2 and 3 (BSL2 and BSL3) laboratories for the quality control and cell culture activities and controlled-atmosphere areas for the manufacture of cell and virus banks. Storage areas are also part of our facilities for the long-term preservation of material at +5 +/- 3°C, -25 +/- 10°C, -80°C and in liquid & vapor phase LN2 dewars.
Our high-performance facility consists of BSL1 & BSL2 areas with a controlled atmosphere which ensures proper operation safety, total confinement and the preservation of material used for bioprocess development, manufacture of cell and virus banks and production of clinical lots.
Observing the GMP regulatory framework
The observance of the GMP (Good Manufacturing Practices) regulatory framework is imperative to ensure the quality, reliability and safety of our services.
ANSM (Agence Nationale de Sécurité du Médicament, French Medicine Agency) arranges periodic inspections of our quality system, ensuring compliance and issuing corresponding GMP licenses.