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Clean Mails – Revue scientifique trimestrielle

BSL3 GMP manufacturing suite – Naobios

Naobios is a GMP-certified company with a high-quality and long-term experience in manufacturing of preclinical and clinical lots of viral vaccines (live or inactivated), viral vectors and oncolytic viruses. Naobios is a GMP establishment certified by French authorities (ANSM).

Extensive manufacturing suites and capabilities

In terms of manufacturing capabilities, Naobios provides:

  • A multi-purpose facility with production by campaign
  • Operations defined for the manufacturing of:
    • Cell banks
    • Viral seed banks
    • Drug Substance: inactivated or live viral vaccines, viral vectors
    • Process validation: inactivation process, aseptic process, cleaning
  • Maximum production working volumes: 200L
  • Adapted suites for GMO, BSL2 and BSL3 pathogens

A highly-secured BSL3 GMP manufacturing suite

Our BSL3 GMP manufacturing suite is a GMP unit of 110m2 (1184ft²) featuring Class D and Class C clean rooms fulfilling the requirements to handle organisms belonging to Risk Group 3:

  • All safety and environmental requirements
  • Solid waste decontamination by a dedicated autoclave while liquid waste undergoes station-mediated continuous decontamination.
  • Critical environmental parameters are monitored 24/7 by an Environmental Monitoring System (EMS).
  • Operations are strictly segregated and flows of people, material and waste have been designed per GMP requirements.

The BSL3 GMP manufacturing suite may accommodate various stages of bioproduction:

#STEP 1: Virus stock / Cell bank production process:

#STEP 2: Bioproduction