Fill and Finish Manufacturing
The Partner of Choice for Flexible Aseptic or Non Sterile Filling of Personalized Medical Products in Europe
Our Fill and Finish manufacturing is suited for medicine products with small and medium volume batches (ATMPs or API). Our filling lines offer a wide range of formats, including bags, vials (glass or plastic), bottles and cryotubes, with semi-automatic dispensing of precise volumes ranging from <1mL to 2L. Our specialized processes maintain sterility and minimize product loss, ensuring safety and integrity of our clients’ high value products.
Aseptic Filling: Flexibility, Compliance, Risk Reduction for ATMP
- Fill line adapted for ATMPs: Flexible and accurate dedicated fill lines for ATMPs to accommodate bags, bottles, vials and cryotubes
- API capacity: Our filling line allows production of 1000 to 1500 vials per day of Active Pharmaceutical ingredients (APIs) and drug substances (DS)
- GMP and regulatory compliance: Partner of choice for cGMP aseptic fill and finish to comply with EMA or FDA standards
- Reducing risk: Our state-of-the-art facility is tailored for aseptic filling in bags (100 ml to 200 L), and non-sterile filling in bags, vials and bottles
- Storage at room temperature: 2°C, - 8°C, -20°C, -80°C, and -196°C cryostorage
Fill and Finish Process
We carry out the four main steps of a fill and finish process: formulation, sterile filtration, aseptic filling, and documentation preparation.
Flexible Filling Tailored to Your Needs
Our small fill-lined can be customized for personalized medicinal products:
- Choice of containers: glass or plastic bottles, bags, ready-to-fill AT-closed vial
- Dispensing volumes: Ranging from 50 microliters to 200 liters
- Manual or semi-automatic distribution
GMP-Compliance
We have manufacturing authorisation from French competent authority (ANSM). Work under cGMP guidelines and able to satisfy FDA or EMA requirements.
Partner of Choice for Fill and Finish of Novel Therapeutics
- End to end services from feasibility to pilot batches
- Certified facility for EU regulatory compliance
- Small line with full flexibility
