BSL3 Capabilities
A cutting-edge facility for GMP bioproduction
At Naobios, we pride ourselves on providing advanced bioproduction services. Thanks to our experencied and talented team, Naobios is positioned as a key player in the CDMO business based on the use of viruses including BSL3-classified pathogens.
In a sector where biological safety, innovation and technical expertise are essential, having a biosafety level 3 (BSL3) infrastructure is a major strategic asset. Our company is distinguished by a rare capability: we design, develop and validate processes in a GMP qualified BSL3 environment that we control completely. Naobios BSL-3 GMP facility offers the ideal environment for development and production of viral vaccines and Human Viral Challenges Agents.
Our BSL3 facilities
Our in-house BSL3 laboratory reflects our deep commitment to safety, quality and technical performance. This state-of-the-art facility is designed in strict compliance with Good Manufacturing Practices (GMP) and international biosafety guidelines. It meets the highest biosafety standards, rigorously adhering to the regulations set forth in the French decree of 16 July 2007 (NOR: MTST0756429A).
These requirements are specifically intended to ensure the protection of personnel exposed to biological hazards, to prevent any contamination of the surrounding environment and to guarantee our customers complete traceability and irreproachable regulatory compliance.
Our BSL-3 suite is a flexible 110sqm (1184ft²) space with a spacious class D room and a segregated class C room. This suite can be used for any standard virus manufacturing process both upstream and downstream.
Both suspension-and adherent based upstream processes may be accommodated for manufacturing scales up to 200L and 200sqm, respectively. In terms of downstream processes, Naobios is equipped with mechanical lysis equipment and can perform any type of required filtration, standard clarification and ultrafiltration/diafiltration setups. Chromatography systems are available and suitable for all scales of manufacturing performed at Naobios.
Our BSL3 workshop is designed to the highest standards:
1. Design and Access Control
- Access through a double-door airlock system to prevent simultaneous door openings.
- Hermetic closure of the laboratory for decontamination purposes. This is mandatory to ensure complete isolation during disinfection.
2. Environmental Controls
- HEPA filtration systems for both incoming and outgoing air, ensuring containment of airborne pathogens.
- Negative pressure maintained within the laboratory to prevent pathogens from escaping into adjacent areas.
- Airflow alarm systems to detect any abnormal changes in pressure, ensuring ongoing containment.
3. Containment and Decontamination Procedures
- Decontamination of waste and materials before leaving the laboratory, typically using autoclaving or chemical sterilization.
- Inactivation of biological agents in effluents by appropriate means.
4. Internal Facilities
- Impermeable and resistant surfaces throughout the laboratory, including floors, walls, and ceilings, ensuring no inaccessible areas for cleaning.
- Autoclave available within the laboratory or in close proximity for efficient decontamination.
Naobios BSL3 track-record
We have a solid expertise in handling BSL3 viruses, thanks to our high-security infrastructure and experienced team.
- We have manufactured more than 10 GMP batches of Poliovirus viral vaccine at 50L and 200L scale.
- We are contributing to several projects involving SARS-CoV-2, right from the start of the pandemic, with several viral vaccines and challenge agents manufacturing projects (ie for Bill and Melinda Gates Fundation _ see our press release).
- Naobios is currently developing the process for the manufacturing of a live attenuated HIV vaccine (ie for Sumagen/Creo SG Co., Ltd _ see our press release).
Thanks to our mastery of BSL3 environments, we are able to handle all quality tests relating to processes, raw materials or finished products.
We also develop and validate analytical methods tailored to the requirements of each project.
We provide a complete range of services, from starting material manufacturing, USP and DSP process development and GMP manufacturing of Drug Substance and Drug Product, including GMP quality control testing.
Our end-to-end solution, scientific expertise, track record and state-of-the-art GMP facility make us a reliable, agile and responsive partner.
To know more about one of our BSL3 project:
Learn more about our role in Sumagen Project, and how our BSL-3 expertise, operational agility, and commitment to global health make us a trusted partner in complex biologics development.