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