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Seneffe, Belgium, Europe
Viral vector manufacturing facilities
Our Seneffe facility is designed to provide comprehensive viral vector services, from process development to commercial manufacturing. This facility has over 20 years of experience in virus and viral vector manufacturing, and has been previously approved by the EMA and the FDA for commercial vaccine production.
Spanning 3200 m2, it excels in the manufacturing of viral vectors for both clinical and commercial applications. The facility provides clinical and commercial manufacturing, as well as fill-finish services.
Thermo Fisher’s Seneffe centralized warehouse offers 4,000 m2 of storage space for raw materials and equipment.
Seneffe is part of our European network of viral vector sites, which includes Gosselies, Belgium, and part of our global network, including Cambridge, and Plainville, MA in the USA.
Key Capabilities:
- Experience in viral vector, virus clinical and commercial manufacturing for cell and gene therapies, vaccine applications and other therapies
- 4 cGMP manufacturing lines (17 suites) for upstream and downstream processing (2,600 square meter, ~28,000 square feet)
- Mid to large scale capacity: up to 2,000L scale
- Suspension and/or adherent modes
- Dedicated fill/finish plant (500 sq.m, 5,400 sq. ft.)
- Automatic filling (up to 10,000 vials/session)
- Customizable (volume, stoppers, vials)
- 2mL to 100mL vials
- Filled volume: 0.25mL to 100mL
- Process validation lifecycle including PC, PPQ and CPV.
- Quality control labs (750 sq.m, 8,000 sq. ft.)
- cGMP analytical method expertise including method validation
| Aseptic Fill and Finish Services | |||||||||
| Quality Control Labs | |||||||||
| Clinical Manufacturing & Commercial Manufacturing |
To learn more about this location, download the site capabilities factsheet.
Helpful Resources
Infographic
Infographic
Regulatory pathways for CGT and ATMP products
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Blog post
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Viral vector commercialization – Part 2: Best practices in process validation lifecycle
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