Your Expert in Sterile Fill-Finish
Sterile Programmes Are Complex.
Your CDMO Partner Shouldn’t Add to That.
As your dedicated sterile fill-finish CDMO, Adragos Pharma addresses the challenges that CMC and outsourcing teams face most — from lyophilisation complexity to clinical-to-commercial scale-up risk. Here is how we help you reduce risk at every stage of your sterile programme.
An integrated aseptic manufacturing network combining sterile fill-finish, lyophilisation, inspection and packaging. Built to take your product from clinical batches to high-volume global supply across France, Switzerland and Japan.
Scale-Up
Clinical-to-Commercial Scale-Up Risk
Technology transfer gaps and capacity mismatches are among the leading causes of sterile programme launch delays. You need an aseptic manufacturing partner with proven scale-up infrastructure — not one learning on your batch.
Lyophilisation
Lyophilisation Complexity
Freeze-drying cycle development, qualification and transfer are technically demanding. Without established lyophilisation expertise and validated equipment, lyo becomes your critical path risk.
Tech Transfer
Technology Transfer Risk
Poorly structured transfers lead to deviations, rework and timeline overruns. A disciplined, project-managed sterile technology transfer protects your product integrity and your schedule.
Regulatory
Regulatory & Audit Exposure
EMA and FDA inspection readiness requires rigorous quality governance and a CDMO with a demonstrable sterile manufacturing audit track record — not just assurances that one exists.
Supply Chain
Supply Chain Continuity
Single-site dependency creates fragility. A flexible multi-site sterile network with common quality governance provides the supply chain resilience your programme demands.
Watch Our Webinar on De-Risking Sterile Fill-Finish from Clinical to Commercial with our sterile fill-finish CDMO team!
Sterile Fill-Finish CDMO Services for Every Dosage Format
Liquid & Lyophilised Vials
Aseptic fill-and-finish and freeze-drying for clinical trial materials through to commercial supply. Including complex formulations, biologics and controlled substances.
- Clinical trial material manufacturing: feasibility → preclinical materials → GMP batches + secondary packaging and clinical kit preparation
- Aseptic liquid filling and lyophilisation including biologics, complex formulations and controlled substances
- Sterile vial filling at up to 300 vials per minute
- Freeze-drying capacity up to approximately 70,000 vials per batch
- Long-term stability storage under ICH conditions; HPLC validation; suitability testing (sterility, endotoxin, bioburden)
- GMP- and FDA-compliant production for clinical and commercial supply
Prefilled Syringes (PFS)
High-precision, ready-to-use prefilled syringes for biopharmaceuticals, vaccines and complex injectables — ensuring sterility, accuracy and ease of administration at up to 150 million units per year
- 2 RABS aseptic filling lines at up to 540 prefilled syringes per minute (0.5–1 mL formats)
- Automated visual inspection: 2 Seidenader lines at up to 600 syringes per minute
- 6 packaging lines including a dedicated plastic-free line; kit formats from 2 to 76 syringes including BIB options
- Three PFS types: Standard, Preventis™ and Eris™
- Integrated compounding, aseptic filling and automated CIP/SIP sterilisation systems
- Controlled aseptic environments with active RABS for biologics and complex formulations
- EMA- and FDA-compliant; regularly audited by more than 10 international health authorities
Ampoules
Precision sterile ampoules with aseptic filling or terminal sterilisation options, supported by a comprehensive automated, semi-automatic and manual inspection capability.
- 4 production lines: 2 aseptic with RABS and 2 non-aseptic
- Aseptic filling or terminal sterilisation by heat
- Formulation batch sizes from 30 to 1,500 L; up to 120M units per year
- Inspection: 3 fully automatic lines + 2 semi-automatic + manual inspection workshop
- Visual inspection and packaging services for Japan pharmaceutical market entry (Kawagoe)
Download Our Sterile Cluster Brochure!
Learn more about our sterile manufacturing capabilities and services across our Sterile CDMO Network.
One Sterile Fill-Finish CDMO Partner.
Every Stage. One Quality Mindset.
We combine multinational operational strength with personalised service — investing in your product’s success beyond standard timelines, from technology transfer through to lifecycle management.
Quality is at Our Core
Quality defineseverything we do,ensuring reliability,compliance, trustedpartnerships, andconsistent productexcellence.
Legacy Meets Innovation
With three centuries of collective experience from leading pharma, biotech and strategy sectors, we deliver innovative aseptic manufacturing solutions grounded in established practice.
R&D as a Profit Centre
Our proactive and value-driven R&D focuses on transforming scienceinto regulatory-ready, scalable and market relevant products, specifically value-addedgenerics.
End-to-End Solutions
Seamless end-to-end CDMO support. From development to commercial manufacturing, all in one trusted partnership.
Masters of Market Adaptability
Our established presence in Japan, the world’s most demanding regulatory market, demonstrates our adaptability, commitment to quality and long-term vision as a global sterile CDMO.
Sterile Capability Snapshot
Up to 540/min
Up to 600/min
Up to 300/min
~70,000 vials/batch
Up to 120M units/yr
30 – 1,500 L
Our Sterile Fill-Finish CDMO Network
Four specialised sterile sites across France, Switzerland and Japan, each playing a defined role in your programme, all operating under one governance framework and one quality mindset.
Adragos Hub
Find out more about sterile liquids.
Sterile Fill-Finish CDMO — Frequently Asked Questions
Common questions from CMC, outsourcing and technical operations teams evaluating a sterile fill-finish CDMO partner.
What sterile fill-finish CDMO services does Adragos Pharma offer?
Adragos Pharma offers an integrated sterile fill-finish CDMO service covering prefilled syringes (PFS), liquid and lyophilised vials and ampoules — from clinical trial material manufacturing through to high-volume commercial supply. Our sterile network spans four GMP-certified sites across France, Switzerland and Japan, all operating under one governance framework and one quality mindset.
Can Adragos Pharma manage our full sterile technology transfer?
Yes. Our Jura and Maisons-Alfort sites are experienced in structured sterile technology transfer — including process characterisation, validation, stability bridging and regulatory CMC alignment. We provide dedicated project management with continuous support from feasibility through to GMP production, ensuring your product integration is seamless and your timelines are protected.
What lyophilisation CDMO capabilities does Adragos Pharma offer?
We offer lyophilisation CDMO services at both clinical and commercial scale. Our Jura site in Switzerland supports freeze-drying for Phase I–III clinical trial materials, while our Maisons-Alfort site in France delivers commercial-scale lyophilisation at up to approximately 70,000 vials per batch. Our teams support cycle development, transfer, qualification and long-term stability storage under ICH conditions.
Do you support clinical trial material manufacturing for sterile injectables?
Yes. Our Jura, Switzerland site specialises in GMP clinical trial material manufacturing for Phase I–III, covering liquid and lyophilised vials. We support the full journey from feasibility through preclinical materials, GMP manufacturing, secondary packaging and clinical kit preparation — with continuous project management support throughout. Our sterile fill-finish CDMO team ensures quality and compliance at every step.
Which regulatory authorities audit your sterile manufacturing sites?
Our sterile fill-finish facilities are GMP-certified and regularly audited by more than 10 international health authorities, including the EMA (European Medicines Agency) and FDA (U.S. Food and Drug Administration). Our Kawagoe site in Japan additionally meets the requirements of the PMDA. Site-specific certificates and regulatory approvals are available upon request — please contact info@adragos.com.
Can Adragos Pharma manufacture biologics by aseptic fill-finish?
Yes. Our aseptic fill-finish capabilities extend to biologics, complex formulations and controlled substances. Our Maisons-Alfort and Jura sites are equipped with validated CIP/SIP systems and active RABS aseptic environments, ensuring the highest standards of contamination control. Our experienced formulation teams work closely with clients to address the specific challenges of biological product manufacturing.
How does your multi-site sterile network support supply continuity?
Our integrated sterile CDMO network spans four sites — Maisons-Alfort and Livron in France, Jura in Switzerland and Kawagoe in Japan. All sites operate under one governance framework and one quality mindset, providing supply chain resilience, flexibility and the ability to support your programme at every stage — from clinical manufacturing to high-volume global commercial supply.
