Seneffe, Belgium, Europe

Viral vector manufacturing facilities

Seneffe, Belgium, Europe

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.

Location Image

Rue de la Marlette n°14,
B-7180 Seneffe (Zoning C),
Belgium

Viral vector manufacturing and development capabilities at Plainville facility

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
Facility Offering
Specifications
Aseptic Fill and Finish Services
  • Clinical and commercial Fill & Finish facility
  • Automatic filling under isolator
  • Up to 10,000 vials per session
  • 2 suites
  • Grade C formulation suite with operations under biosafety cabinet grade B and aseptic suite withoperations under grade A (isolator)
  • Quality Control Labs
  • Centralized QC
  • Compendial tests
  • Identity test
  • Specific testing
  • Elisa, qPCR, cell culture base test, TCID 50
  • Clinical Manufacturing & Commercial Manufacturing
  • Clinical and commercial Drug Substance facilities, manufacturing suites for mid to large-scale production
  • Suspension using bioreactors ranging from 50L to 2,000L
  • Adherence mode in CS10 or HS36
  • Experience in Fixed-bed bioreactor (iCELLISTM)
  • Up to 4 productions in parallel
  • 4 production lines (17 suites)
  • Grade C production suites with operations under biosafety cabinet grade B
  • Modular area cGMP multiprocess/Clinical facility,multiproduct facility
  • To learn more about this location, download the site capabilities factsheet.

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