DP Sterile Manufacturing
Eurofins CDMO (Contract Development & Manufacturing Organization) provides a wide range of aseptic processing services for all drug product configurations with flexibility to accommodate a wide range of compounds, primary packaging systems, batch sizes and fill volumes to help develop your Active Pharmaceutical Ingredient or bulk product into Finished Dosage Forms for use in clinical trials and commercial purposes.
We perform sterile fill & finish activities for large and small molecule products under full global, GMP-compliance with finished dosage forms according to customer requirements and drug product specifications. We have authorizations for nearly all drug substances and are able to handle biotech products, nanocarriers, highly potent products and controlled substances.
Choose Eurofins CDMO to help you:
✔ Develop customized fill & finish approaches for unique, specialized needs.
✔ Process your small batches with a very low line loss (down to less than 15 ml).
✔ Optimize the manufacturing process to your primary packaging (vials, syringes, monodoses, IV bags, cartridges, others).
✔ Achieve easy scale up and optimal process transfer.
✔ Execute terminal sterilization for special class API, which cannot be filter sterilized.
✔ Perform related testing services before and after fill & finish, including release & stability testing, packaging, labeling, and batch certification by a Qualified Person.
Our production lines can support a broad range of fill volumes ranging from 15 µl (hand-fill) to 50 mL and a minimum of dead volume (less than 15 ml). Bulk drug products can be either manufactured on our sites or delivered ready to fill.
Primary packaging & batch sizes
From disposable product contact parts to full disposable material, our system is fully integrating all the requirements to prevent you from waiting for your product while you are in development phase.
|Bulk||From <0,5L & up to 200L|
|Vials||Up to 5,000 units|
|Bottles 50 mL- 1L||Bulk up to 200L|
|Syringes||Up to 10,000 units|
|Monodoses||Up to 1,600 units|
|IV Bags||Bulk up to 200L|