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Aseptic filling for CDMO
ProBioGen is a Berlin-based CDMO with 30+ years’ expertise in biologics, viral vectors, and vaccines, delivering GMP-compliant manufacturing with innovative proprietary technologies.
Strategic Challenge and Project Requirements
Before implementing the automated L1 filling line, ProBioGen needed to expand its capabilities in aseptic drug product manufacturing while ensuring full compliance with GMP Annex 1. The company sought a solution tailored to virus production, with minimal manual intervention, sterile ready-to-use vials, and disposable product-contact materials to eliminate cleaning validation.
Space limitations also played a role, requiring a compact system that could fit into existing cleanroom facilities while still providing a reliable aseptic environment (Class A).
Solution Analysis: L1 Filling Station & AT-Closed Vial®
To meet these requirements, ProBioGen implemented the AT-Closed Vial® Technology alongside the L1 filling station. The AT-Closed Vial®, sterile and pre-assembled, eliminated open handling and reduced contamination risk, while its cryogenic resistance supported sensitive product storage.
The system was delivered and installed smoothly, with AT providing hands-on training and a solution-oriented partnership. No significant customizations were needed — the focus remained on establishing robust aseptic conditions and semi-automated filling.
With the L1 filler, ProBioGen can now manufacture vaccines under GMP Annex 1 compliance, supporting both clinical projects and the acquisition of new customers. This investment strengthens its position as a CDMO offering both drug substance and drug product manufacturing.
Looking ahead, ProBioGen views the system as a foundation for growth, ensuring scalability, flexibility, and readiness for evolving regulatory expectations in sterile fill & finish.
Tanja Arnouk
Head of Viral Vector Processing Development & Production at ProBioGen
“The L1 filler gives us a reliable setup for high-quality runs, and because it’s so flexible, we know it will support future projects and different production needs.”
Figures and facts
Cryogenic compatibility
Vials withstand ultra-low temperatures, ensuring safe storage of sensitive products.
Annex 1 compliance
The L1 filler ensures aseptic manufacturing in line with GMP requirements.
New customer opportunities
Expanded capabilities in sterile drug product manufacturing strengthen competitiveness.