Aseptic Fill & Finish Services for Commercial Products
In addition to developing products and scaling them up to our commercial production lines, we also offer aseptic contract filling services for fully developed and approved products. We use the latest state-of-the-art filling equipment from groninger (filling line), SKAN (isolator) and Martin Christ (freeze dryer) with an annual capacity of approx 15 million Ready-To-Use (RTU) primary packaging containers. This includes pre-filled syringes, vials and cartridges in glass and polymer. Our premises, filling equipment, associated processes and risk assessments already meet the requirements of the new EU GMP Annex 1 today.
Our End-to-End CDMO Services for Commercial Products
- Manufacturing and compounding of drug substance
- Aseptic filling, stoppering and closing of pre-fillable syringes, vials and cartridges in different batch sizes up to around 200 liters
- Capabilities for nitrogen overlay / gassing and vacuum options for oxygen sensitive products
- Capabilities to process toxic products (up to OEB 5) and active substances (up to S2 requirements)
- Terminal sterilization
- Analytical services for product release
- Visual inspection, labelling and secondary packaging including GMP storage
- Storage and shipping of products at ambient temperature, cooled at 2°- 8° or frozen down to -75°C.