Aseptic Fill & Finish

Aseptic Fill & Finish Services

  • Sterile drug products – aseptically prepared
  • Liquid formulations in vials
  • Wide range of molecules:
    • Small molecules (including peptides)
    • Nanomedicines
    • Biotechnology products (e.g. recombinant proteins, monoclonal antibodies)
  • Small to medium scale batch sizes
  • Clinical trial material (IMP)

State-of-the-art Aseptic Production Area

300 m² production area designed in accordance with EU GMP Annex 1

  • Cleanroom area (Grade C) with separate weighing room, compounding room and 2 filling rooms
  • Visual inspection room
  • Secondary packaging and labelling room
  • Material and drug product staging area
  • State-of-the art environmental control and monitoring (EMS)

Filling rooms equipped with closed isolator technology

  • Physical barrier between drug product and environment
  • Integrated EMS
  • Automated VHP decontamination cycle
  • Power supply backup (UPS and EPS)

Technical Capabilities

  • Aseptic technology: Isolator with double sterile filtration including PUPSIT
  • Filling technology: Bubble-free filling process with 100% IPC (fill-to-weight)
  • Formulation: Aqueous solutions
  • Container: Glass vials with push-fit caps
  • Vial sizes: 2R and 10R (other sizes upon request)
  • Batch size: Up to 3000 vials
  • Storage condition: -80°C to room temperature
  • One-stop-shop: Development, manufacturing, QC, labelling, certification and shipment