Sterile Injectable Fill-Finish CDMO

Adragos Pharma provides sterile injectable fill-finish Contract Development and Manufacturing Organisation (CDMO) services across three European manufacturing sites in France and Switzerland, supported by visual inspection and packaging capability in Japan. From early-phase clinical batches through to high-volume commercial supply, the network covers aseptic fill-and-finish for liquid and lyophilised vials, prefilled syringe manufacturing and ampoule production for both small molecules and biological products. All European sterile sites hold EU-GMP certification; the Jura facility additionally holds United States Food and Drug Administration (FDA) and Swissmedic approval.

What Is Sterile Injectable Fill-Finish and Why Does CDMO Selection Matter?

Sterile injectable fill-finish is the process of filling a sterile drug substance into its final primary container, whether a vial, prefilled syringe or ampoule, under precisely controlled aseptic conditions. For pharmaceutical and biotechnology companies outsourcing this process, selecting the right CDMO determines whether a product reaches clinical and commercial markets on schedule, in compliance with international regulatory requirements.

A qualified fill-finish partner must demonstrate verified aseptic capability, validated container closure integrity, scalable manufacturing infrastructure and certification by the relevant health authorities for each target market. Audit-readiness, controlled substance handling, a structured Clinical Trial Material (CTM) programme and a defined pathway from clinical to commercial scale are equally important selection criteria.

Adragos Pharma’s Sterile Injectable Manufacturing Network in Europe

Adragos Pharma operates a coordinated sterile manufacturing cluster across three European facilities, each configured for a specific manufacturing scope. This structure allows clients to access the appropriate technology and scale at every stage of the product lifecycle, within a single CDMO relationship.

Maisons-Alfort, France: High-Volume Commercial Sterile Fill-Finish

The Maisons-Alfort facility is the large-scale commercial fill-finish hub within the Adragos network, with over 77 years of specialisation in sterile drug manufacturing. It is designed for high-speed aseptic filling of prefilled syringes and both liquid and lyophilised vials, and operates under Restricted Access Barrier System (RABS) and Clean-in-Place/Sterilise-in-Place (CIP/SIP) technologies. The site holds EU-GMP certification and is approved by 12 international health authorities.

Prefilled Syringe Capabilities

• Two filling lines with RABS technology
• Three syringe formats: Standard, Preventis™ and Eris™
• Maximum filling capacity of up to 540 syringes per minute
• Annual output of 150 million units
• Available formats: 0.5 mL and 1 mL
• Two Seidenader inspection lines with 100% automated inspection at up to 600 syringes per minute
• Five thermoforming packaging lines including a dedicated plastic-free line for Eris™ syringes
• Packaging speed of up to 360 syringes per minute
• Kit formats ranging from 2- to 76-syringe packs including Bag-in-Box configurations

Liquid and Lyophilised Vial Capabilities

• One filling line with RABS technology
• Two large automated loading and unloading freeze-dryers
• Filling speed of up to 300 vials per minute
• Freeze-drying capacity of up to 74,000 vials per cycle
• Crimping speed of up to 350 vials per minute
• Vial formats from 2R to 100R
• Semi-automated inspection at up to 100 vials per minute
• One plastic-free packaging line for vials with ampoules and one blister line for vial kits

Jura, Switzerland: Aseptic Fill-Finish for Clinical and Commercial Vials

The Jura facility has specialised in aseptic fill-and-finish for liquid and lyophilised vials for over 25 years. It serves clients requiring Clinical Trial Material production and small-to-medium scale commercial manufacturing, with no minimum batch size constraint. A three-month turnaround from order to batch, including controlled drug handling where required, makes this site particularly suited to early-phase development programmes and high-value assets.

The site produces approximately 200 clinical batches per year and has supported five successful commercial product launches. It handles up to 12 client audits per year and holds certifications from the European Medicines Agency (EMA), the FDA and Swissmedic.

Key Manufacturing Capabilities

• Batch size up to 74,400 vials
• Vial formats: 2R, 6R, 10R, 20R and 30R
• Sterile liquid formats: liquid, suspension, emulsion and viscous liquid
• RABS-enabled aseptic processing supporting both closed system and open handling configurations
• Peristaltic and rotary piston pump options for flexible formulation
• Lyophilisers with 3 m² and 9 m² shelf capacity
• Suspension formulation, rehomogenisation and aseptic filling with process qualification
• Single-use strategy to minimise cleaning validation burden and reduce the risk of cross-contamination

Analytical and Stability Services

• Long-term stability storage under International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) conditions
• Analytical testing at intermediate and final stability points
• High Performance Liquid Chromatography (HPLC) validation
• Sterility suitability testing
• Endotoxin suitability testing
• Bioburden suitability testing

Livron, France: Aseptic and Terminal Sterilisation for Ampoules

The Livron facility has over 110 years of manufacturing experience and focuses on sterile liquid ampoule manufacturing and suppository production. It provides both aseptic filling and terminal sterilisation by heat, accommodating molecules where each method delivers the most appropriate stability profile. The site holds EU-GMP, France-ANSM, France-ANSES and Korea-KFDA certification.

Key Manufacturing Capabilities

• Four production lines: two aseptic lines equipped with RABS technology and two non-aseptic lines
• Batch sizes from 30 L to 1,500 L
• Ampoule formats from 1 mL to 10 mL
• Annual ampoule output of 120 million units
• Three fully automated visual inspection lines covering optical, cosmetic and pinhole detection with integrated labelling
• Two semi-automatic inspection lines and a dedicated manual inspection workshop
• Three blister packaging lines supporting configurations of 1, 3, 4, 5, 6, 10, 20, 25 and 50 ampoules
• Pre-cut blister option available
• Controlled drug handling capability

Clinical-to-Commercial Technology Transfer

Adragos Pharma supports structured technology transfer from clinical to commercial scale within its sterile manufacturing network. The Jura facility provides the clinical manufacturing infrastructure, guiding products from feasibility assessment and preclinical material preparation through to GMP-compliant batch production. When commercial volumes are required, manufacturing can be transitioned to the higher-capacity Maisons-Alfort site for prefilled syringes and vials, or to Livron for ampoule formats.

The Adragos approach to technology transfer covers:

• Project feasibility: Technical, GMP and budgetary evaluation prior to production commitment
• Pilot batches and process alignment: Laboratory and pilot-scale studies conducted before scale-up to GMP manufacturing
• GMP manufacturing: Full production of clinical or commercial batches under GMP conditions
• Secondary packaging and clinical kit preparation: Bespoke packaging configured to clinical trial or market requirements
• Temperature-controlled global distribution: Secure shipment of analytical samples and finished product
• Stability studies under ICH conditions: Long-term storage, intermediate and final stability point testing to support Chemistry, Manufacturing and Controls (CMC) dossier preparation

CMC Documentation Support and Regulatory Certifications

Adragos Pharma’s sterile fill-finish facilities hold certifications from multiple international health authorities, enabling clients to file for approval in major global markets from a single European manufacturing source.

Facility	Regulatory Certifications
Maisons-Alfort, France	EU-GMP; approved by 12 international health authorities
Jura, Switzerland	EMA; FDA; Swissmedic
Livron, France	EU-GMP; France-ANSM; France-ANSES; Korea-KFDA

The team manages ICH stability studies and clinical study documentation to support dossier submission for regulatory approval. This includes preparation aligned with a first-time-right submission philosophy, structured to reduce the risk of regulatory queries during the review process.

Capacity Assessment for Prefilled Syringe and Vial Manufacturing

Adragos Pharma can support formal capacity planning discussions prior to programme commitment, enabling clients to assess whether site throughput aligns with projected commercial demand.

For prefilled syringe manufacturing, the Maisons-Alfort facility offers the highest throughput in the network, with filling capacity of up to 540 units per minute and an annual output of 150 million syringes across 0.5 mL and 1 mL formats.

For vial manufacturing at clinical and early commercial scale, the Jura facility operates without batch size restrictions. This allows the production of limited-volume, high-value material, including controlled substances and biological products, without requiring minimum order commitments. Batch sizes scale up to 74,400 vials per cycle.

CDMO Audit and Onboarding

The Jura facility manages up to 12 client audits per year, reflecting the audit-readiness and quality maturity of the site. From the point of project initiation, Adragos assigns a single dedicated project contact to each client, maintaining consistent communication across the full onboarding and production cycle.

For clients initiating sterile fill-finish development at Jura, the three-month turnaround from order to first batch applies across the range of liquid and lyophilised vial formats and includes controlled drug handling where required.

Frequently Asked Questions

Why Choose Adragos Pharma for Sterile Injectable CDMO Services?

• Three centuries of collective manufacturing experience across the Adragos team
• EU-GMP and FDA-certified sterile facilities in France and Switzerland
• Clinical-to-commercial continuity within a single CDMO relationship
• No minimum batch size at the Jura clinical facility
• 100% automated inspection capability and container closure integrity verification
• Controlled substance handling at multiple sites
• Biological product aseptic fill-and-finish capability
• Regulatory coverage supporting access to EU, US, Swiss and additional international markets
• Single dedicated project contact from onboarding through to product release

Discuss Your Sterile Fill-Finish Requirements with Adragos Pharma

To request a capacity assessment, initiate an audit or discuss clinical and commercial manufacturing requirements, contact the Adragos Pharma team directly at www.adragos-pharma.com.