Facility
CellVec’s state-of-the-art GMP manufacturing facility, constructed based on the principles of the PIC/S GMP guide, Eudralex Vol. 4 and relevant annexes, encompasses the process-driven design approach that we adopt for the manufacture of viral vectors for gene therapy and other cellular ATMPs. Our GMP production Clean room facility is constructed to accommodate flexible Viral Vector production runs, where we focus on a single product at a time, on a campaign basis.
Our GMP Certified Facility
Where Quality, Efficiency And Safety Find The Right Balance
Facility features:
- Designed to meet Biological Safety Containment Level 2 (BSL2) requirements
- Clean room pressurisation design following pressure bubble and sink concept, validated against ISO 14644:2015, to prevent the risk of cross contamination
- Designed for full facility decontamination using hydrogen Peroxide vaporization
- Grade A Bio Safety Cabinet (BSC) and Isolators for production operations
- Grade B and C background cleanrooms fitted with ULPA and HEPA 14 filters
- Restricted passage fitted with electronic access control and pressured airlocks for controlled entry and exit of material and personnel
- Equipped with 24/7 monitoring and an alarm system
- Continuous QC environmental monitoring under a validated environmental monitoring system (EMS)
Facility features:
- Designed to meet Biological Safety Containment Level 2 (BSL2) requirements
- Clean room pressurisation design following pressure bubble and sink concept, validated against ISO 14644:2015, to prevent the risk of cross contamination
- Designed for full facility decontamination using hydrogen Peroxide vaporization
- Grade A Bio Safety Cabinet (BSC) and Isolators for production operations
- Grade B and C background cleanrooms fitted with ULPA and HEPA 14 filters
- Restricted passage fitted with electronic access control and pressured airlocks for controlled entry and exit of material and personnel
- Equipped with 24/7 monitoring and an alarm system
- Continuous QC environmental monitoring under a validated environmental monitoring system (EMS)