A flexible and multipurpose facility
The Naobios facility comprises one building of 1500m² and one external warehouse of 190m².
The main building gathers activities as follows:
- GMP manufacturing: 327m² (classified areas – grade B, C and D)
- Quality control: 92m² (classified areas);
- Process development activities: 202m²
- Warehouse: 20m²
- Biostorage area: 31m² (classified areas)
The building consists of three levels:
- A basement area with utilities,
- A ground floor with production zones, storage areas, QC laboratories and process development laboratories
- The first floor which consists of offices and the technical areas for the ventilation systems.
There are different HVAC (Heating, Ventilation and Air-Conditioning) and extraction systems, which provide the air conditioning requirements for production area, QC, and process development laboratories. These areas are maintained completely independent from each other in terms of operations, entrances/exits, personnel and material flows and utilities.
Four manufacturing units qualifying as BSL2, BSL2+ and BSL3
The manufacturing area consists of four separate and independent production areas (grades D, C, B and A), a preparation and wash area (grades C and D) and access corridors (grade D). The laboratories and clean areas can be used for open processing steps with biological products, including GMO or live virus. Specific measures have been taken or designed into the facility to avoid cross contamination. Biological containment is assured by a layered approach based on physical separation, the use of air conditioning systems and differential pressures. All laboratories in the building qualify as BSL-2 (Biosafety level 2) and 2 GMP production areas qualify as BSL-2+ (one room is currently being revamped to BSL3).
A multipurpose facility supported by a strict organization
The facility is managed and operated according to a strict Quality Management System (QMS), ensuring compliance, manufacturing support, validation and documentation management controlled by the Quality Assurance Department.
The manufacturing areas operate with dedicated personnel as a multipurpose and multiproduct facility with production by campaign. Up to four completely different products can be handled at the same time.
A cleaning validation approach is defined to minimize the risk of contamination on facility and equipment surfaces and a comprehensive product changeover policy is in place, including validated hydrogen peroxide gassing to avoid cross contamination.