Lyophilisation
At Adragos Pharma’s Jura facility in Switzerland, we specialise in aseptic fill-finish and lyophilisation of sterile vials for clinical trials. With 25 years’ experience in sterile manufacturing and GMP certification by Swissmedic, our Swiss-quality operation combines precision and flexibility to support your molecule from early development through Phase I–III clinical supply.
Lyophilisation for Clinical Trials with No Minimum Batch Size
Our services are purpose-built for clinical-scale lyophilised drug product manufacturing, where small, flexible batches are essential, especially for early-stage development and high-value biologics.
• No fixed minimum batch size: manufacture only what your study requires
• Small batch volumes: down to 200–300 mL bulk solution
• 3.5 m² lyophiliser shelf capacity optimised for aseptic, small-batch production
• Experience across peptides, biologics, sterile suspensions, small molecules and complex formulations
Whether you require material for first-in-human studies or GMP scale-up for later phases, Adragos Jura delivers consistent quality, robust documentation and dependable timelines.
End-to-End GMP Clinical Manufacturing for Lyophilised Vials
Our Swiss site brings the key services for lyophilised vials into one GMP-controlled ecosystem:
• Process alignment and scale-up from development batches to GMP manufacturing
• Technology transfer and freeze-drying cycle development
• Aseptic filling and APS (Aseptic Process Simulation) to support sterility assurance
• Clinical packaging, randomised labelling and kit preparation
• GMP storage and controlled-temperature distribution for clinical materials
• Analytical and microbiological testing including sterility, endotoxin and residual moisture
Each project is supported by structured project management and clear communication to keep your clinical programme on track.
Analytical & Quality Control for GMP Batch Release
Our in-house QC laboratory supports GMP batch release for lyophilised products, including:
• HPLC/UPLC, Karl Fischer (water content), osmolality, sub-visible particle counting
• Sterility and endotoxin testing under isolator conditions
• Long-term stability studies under ICH conditions
• GMP documentation and batch certification in line with Swiss/EMA expectations
This integrated QC capability helps ensure reliable, reproducible results and confident clinical supply.
GMP Compliance & Regulatory Readiness
Adragos Pharma Jura operates under GMP certification by Swissmedic for the manufacture of sterile products (lyophilised and liquid). Our facility runs rigorous aseptic controls, supported by validated processes, APS and ongoing quality monitoring, to meet the requirements of global clinical programmes, including those intended for FDA-regulated pathways.
Why Choose Adragos Pharma Jura?
- Decades of expertise in sterile manufacturing for lyophilised and liquid drug products
- Flexible clinical-scale production with no minimum batch size
- Swiss precision backed by strong GMP systems and inspection readiness
- Transparent project management and proactive client communication
- Proven track record supporting innovative biotech programmes into the clinic
“Working with Adragos Pharma has been instrumental in moving our project forward in a timely manner.”
Thierry Ziegler, COO, Igyxos
Download the Jura Lyophilisation Brochure
Discover our services for biologics manufacturing at our Jura facility in Switzerland.
Lyophilisation Facility in Jura, Switzerland
With more than 6,000 m² of facilities and more than 25 years’ experience, Adragos Jura provides customised clinical manufacturing to support your therapeutic trials.
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