The quarterly scientific journal

15/11/2021

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

 

Subscribe and download our flyer

By submitting this contact form, I accept that the information entered will be used as part of my demand.

To know and exercise your rights, in particular the right to withdraw your consent to the use of the data collected by this form, please consult the general conditions of use related to the management of personal data.