Aseptic Fill-Finish for Commercial Pre-Filled Syringe Programmes
Pre-filled syringes are the primary sterile dosage form manufactured at our Maisons-Alfort site. Our aseptic fill-finish operations are designed to meet the throughput, quality and regulatory demands of commercial-scale supply programmes, integrating advanced contamination control technologies with robust process systems.
Active Restricted Access Barrier System Technology
Our facility is equipped with active Restricted Access Barrier System technology. Active Restricted Access Barrier Systems provide a physical and aerodynamic barrier between the operator and the critical filling zone, maintaining International Organization for Standardization Grade A conditions throughout the fill-finish process.
Clean-in-Place and Sterilise-in-Place Systems
All critical process equipment at Maisons-Alfort is supported by Clean-in-Place and Sterilise-in-Place systems. These integrated cleaning and sterilisation cycles minimise manual intervention, reduce contamination risk and support process reproducibility across commercial batches, contributing to consistent product quality at scale.
High-Speed Aseptic Filling
Our line is configured for high-speed aseptic filling, providing the throughput capacity required to support commercial supply programmes and the flexibility to accommodate varying demand profiles across global markets.
Advanced Visual Inspection
Following aseptic filling, each unit undergoes advanced visual inspection to detect particulate matter, container integrity defects and fill anomalies. Our inspection capability is aligned with the standards set out under
EU Good Manufacturing Practice Annex 1 and supports the quality assurance requirements of regulatory submissions across multiple markets.
Supporting Sterile Injectable Formats
Whilst pre-filled syringes represent the primary fill-finish capability at Maisons-Alfort, the facility also manufactures liquid vials and lyophilised vials. Our large-scale freeze-drying capability serves programmes where lyophilisation is required to achieve the necessary product stability profile. This range of sterile format capability allows clients to consolidate manufacturing across multiple product types within a single European site.
Manufacturing Site: Maisons-Alfort, France
Our Maisons-Alfort facility is a purpose-built sterile manufacturing site located in the greater Paris region of France. The site integrates:
High-speed aseptic filling for pre-filled syringes
Large-scale freeze-drying for lyophilised vials
Advanced visual inspection
Dedicated packaging halls
Robust logistics infrastructure to support global commercial distribution
The facility is structured to deliver continuity of supply, combining manufacturing capacity with the quality systems and logistics capability required for reliable international commercial programmes.
Regulatory Certification and Global Compliance
EU Good Manufacturing Practice and ANSM Certification
Our Maisons-Alfort site operates under EU Good Manufacturing Practice and holds certification from the
Agence nationale de sécurité du médicament et des produits de santé, the French national medicines regulatory authority. This certification confirms site compliance with EU Good Manufacturing Practice requirements and supports product registration and supply across the European Economic Area. The site maintains active audit readiness as a standard operational requirement.
Food and Drug Administration-Ready Site
In addition to EU Good Manufacturing Practice compliance, our facility is positioned as a
Food and Drug Administration-ready manufacturing site. This status enables clients to pursue United States market registration and commercial supply without requiring a change of manufacturing site prior to regulatory submission.
International Regulatory Recognition
Our Maisons-Alfort facility is recognised by regulatory authorities across multiple markets, providing clients with a single European manufacturing base from which to serve global distribution programmes. Current regulatory approvals and certifications include:
This breadth of regulatory recognition reduces the complexity of multi-market supply strategies and enables clients to expand into established and emerging markets from a single, compliant European facility.
Supply Reliability for Global Programmes
For any commercial sterile injectable programme, the ability to maintain uninterrupted supply is as commercially critical as technical manufacturing capability. Our Maisons-Alfort facility is designed to support reliable, on-time delivery at commercial scale, underpinned by robust logistics and quality systems that maintain product integrity from the point of manufacture through to global distribution.
Dedicated packaging halls at the site support the final stages of commercial supply preparation, ensuring product is ready for distribution in line with the requirements of each target market.
Evaluating a European Contract Development and Manufacturing Organisation for Pre-Filled Syringes
Pharmaceutical and biotechnology organisations selecting a European contract development and manufacturing organisation for commercial sterile injectables require a combination of technical capability, regulatory credibility and supply assurance. The key criteria that Adragos Pharma addresses at Maisons-Alfort include:
Commercial-scale aseptic fill-finish for pre-filled syringes, supported by active Restricted Access Barrier System and Clean-in-Place / Sterilise-in-Place systems
EU Good Manufacturing Practice
certification by the Agence nationale de sécurité du médicament et des produits de santé with maintained audit readiness
Food and Drug Administration-ready site status for programmes targeting the United States market
Multi-authority regulatory recognition spanning Asia, Africa and additional international markets
Integrated sterile manufacturing capability including liquid and lyophilised vials for consolidated site strategies
Dedicated packaging halls and logistics infrastructure to support global commercial supply
Discuss Your Pre-Filled Syringe Programme with Adragos Pharma
If you are evaluating European contract development and manufacturing organisation partners for a commercial pre-filled syringe programme, our team at Maisons-Alfort is available to discuss your requirements in detail.
Download the Maisons-Alfort brochure
And learn more about the site’s PFS manufacturing capabilities, sterile vial expertise and integrated service platform
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