Aseptic Fill and Finish
Eurofins BioPharma Product Testing Netherlands provides aseptic Fill & Finish services for pharmaceutical products. Our process is a customized one, resulting in flexibility that allows solutions in a wide range of compounds, primary packaging systems, batch sizes and fill volumes.
Customized Fill & Finish of small scale batches
Our expertise lies at manual small scale GMP manufacturing of liquid or powder, sterile products. This includes:
- Clinical trial material (all phases)
- Small scale commercial batches
- Orphan drugs
- Sterile vials to prepare a Medicinal Product
Services are delivered in a wide range of volumes and packaging systems and to a large array of product types. Our manual techniques gives you great flexibility in your requirements. Eurofins BioPharma Product Testing Netherlands' expertise lies in Fill & Finish of:
- Small molecules
- Biologicals, such as antibodies, proteins, peptides and vaccines
- Hormones, cytostatics and highly potent compounds
Your compound not in the list? Contact us to discuss the possibilities so we can find a solution together.
Available primary packaging and fill volumes
Eurofins BioPharma Product Testing Netherlands performs aseptic Fill & Finish activities, either with a ready-to-fill bulk, or with compounding based on your recipe. If necessary, the compounding process can be designed in close collaboration with us.The sterile filtration and Fill & Finish activities are performed in class A BioSafety Cabinets in class B cleanrooms.
All manufacturing processes use fully disposable contact parts avoiding the need for cleaning. This includes:
- Polymer bag mixing systems
- Sterile filters and tubing assemblies
- Peristaltic filling pumps
As all steps in the process are executed (semi-)manually, services can be offered for the following packaging systems and volumes.
Do you require other packaging systems or volumes? Discuss your needs to find a solution together.
Why choose Eurofins BioPharma Product Testing
- Full GMP manufacturing services in-house available. Eurofins BioPharma Product Testing Netherlands can guide clients through their entire pharmaceutical development process.
- Manual Fill & Finish. A manual approach allows for great flexibility in the process. Contact us if you have specific requirements.
- Release Testing & Stability Study. Testing of Drug Products is our core business. We can help you in the Qualification and Validation of your methods, perform release testing of your product, and deliver the stability data needed for filling.
- Wide range of related services. We can select, purchase and release (EP and USP) your raw materials and excipients. We can release your product for use in the clinic (Batch Certification) and we can help you with labelling, packaging and distribution (GDPR) of your product.