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, Lexington 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
Regulatory pathways for CGT and ATMP products
CGT is one of the world's fastest-growing therapeutic areas today. Instead of treating patients for the rest of their lives, these therapies offer them hope of a cure. In this infographic, we will review three tips for achieving regulatory success.
View Infographic
Blog post
Viral vector commercialization – Part 2: Best practices in process validation lifecycle
Learn more about the robust viral vector process validation cycle, which includes various assessments and studies to ensure the safety, efficacy, and quality of viral vectors.
View Blog Post
Blog post
Viral vector commercialization – Part 3: Specialized regulatory support
Find detailed regulatory considerations when preparing viral vectors for commercialization and best practices to address them.
View Blog Post
eBook
Cell and gene therapies in the US vs. the EU: Top five areas of differentiation
In this eBook we share the five key differences in the drug development and review process for companies hoping to gain market access through US Food and Drug Administration (FDA) or European Medicines Agency (EMA) approval—as well as tips for navigating these differences.