Drug Product
Our drug product manufacturing facility is designed to handle a wide variety of dosage forms including syringes, cartridges and vials. Multiple filling lines with flexible equipment allow us to adapt to your batch size requirements for clinical trial and commercial scale purposes. Visual inspection, label/blister technology and packaging capabilities are available to provide a complete fill&finish service portfolio.
Equipment, systems available
- Flexible lines support various dosage forms like syringe, cartridge & vial filling under sterile conditions
- Automated freeze drying up to 15000 containers capacity (25R), with recipe led automated loading / unloading
- Flexible batch sizes (5L-500L) to support the production of clinical trial material as well as full scale commercial production
- Visual inspection of every vial/cartridge/syringe before labeling and blistering
- Both stainless steel vessels and single use technology (SUT) materials (plastic bags/aseptic connectors) are available
- Restricted access barrier system (RABS): filling processes are contained in a sterile environment. Open RABS are used for fast process changeovers (e.g. from vials to cartridges)
Dosage forms
PFS filling (1-5ml)
Cartridge filling (1.5-3ml)
Vial filling (2R-50ml)
Freeze drying (2R-20R)
Drug product process capabilities
- Syringe, cartridge and vial filling
- Flexible batch sizes (5L-500L)
- Restricted access barrier system (RABS)
- Automated freeze drying
- Experience with biologics and small molecules
- Biohazard 1&2 capability
- Visual inspection and label/blister technology
- Stainless steel/SUT available
- 1 x Syringe filling line 1 x Combination filling line Terminal sterilisation Lyophilisation
- Line 1 is capable of filling vials and cartridges
- Line 2 is capable of filling prefilled syringes and cartridges