DP Sterile Manufacturing / Fill & Finish
Eurofins CDMO (Contract Development & Manufacturing Organization) network of companies 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 aseptic filling 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 including highly potent drug products (HP API until 1 µg/m3)
Our expertise in parenteral formulation and sterile manufacturing covers a large range of small molecules and biologicals (amino acid, peptide, oligonucleotide, plasmid vector, cytokines, protein, immunoglobulin, interferon, mAb, ADC, inactivated bacterias, …).
Sterile production lines
Our production lines can support liquid and lyophilized forms with 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 & aseptic filling 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.
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Bulk |
From < 0,5L and up to 20L per batch |
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Vials |
Up to 5,000 units (e.g. 2R vials) per batch |
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Prefilled syringes |
Up to 5,000 units (e.g. syringes 1mL long) per batch |
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Others |
Upon feasibility assessment and gap analysis per batch |
Choose Eurofins CDMO network of companies 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 aseptic 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.
