Aseptic Filling
At Adragos Pharma Jura, we specialise in aseptic filling and fill-finish of sterile drug products for clinical development (Phase I–III). Our Swiss facility is built to deliver the flexibility, reliability and GMP compliance required for early-stage biopharmaceutical manufacturing, supporting programmes from small pilot batches through to GMP-certified low-volume supply, where applicable.
With 120+ specialists across 20 disciplines, we provide seamless execution and robust quality oversight from formulation transfer to finished clinical supply.
Designed for Small Batches and Complex Formulations
Our Jura facility provides end-to-end aseptic manufacturing services tailored to the needs of clinical programmes and process development.
Core Capabilities
- Aseptic vial filling under GMP conditions
- Liquid sterile products and lyophilised (freeze-dried) vials
- No fixed minimum batch size
- Flexible batch volumes down to 200–300 mL bulk solution and upwards
- Experience with biologics, peptides, sterile suspensions, ophthalmic products and small molecules
- Manufacture of placebos and diluents, plus support for clinical comparators (e.g., blinding/packaging, where required)
All products are manufactured in classified cleanrooms using validated aseptic processes to maintain sterility and product integrity from fill to finish.
Clinical Manufacturing Services for Investigational Medicinal Products
Our aseptic fill-finish offering supports the full clinical supply chain, enabling a smooth transition from development to patient delivery.
- Phase I–III clinical manufacturing
- Process alignment with GMP and technology transfer support
- Pilot batch production
- Scale-up support and process transfer
- Randomised clinical labelling
- Clinical kit preparation
- Secondary packaging and GMP storage
- Controlled-temperature shipping to global clinical sites
From formulation transfer to clinical kit dispatch, Jura provides a controlled and compliant environment for investigational drug products.
In-House Quality Control & Analytical Testing
In-process controls (IPC) throughout filling
HPLC/UPLC for assay and purity
Osmolality, pH, viscosity and TOC
Sterility and endotoxin testing
Bioburden and particulate analysis
Method verification to support analytical and microbiological reliability
Regulatory Excellence & GMP Certification
Comprehensive testing of raw materials, in-process samples and finished product
Operating under Swissmedic GMP certification for the manufacture of aseptically filled sterile drug products (liquid and lyophilised)
Aligned with FDA and EMA expectations to support global sponsors and multi-region submissions
Full documentation and data integrity to support clinical regulatory filings
Quality assurance is embedded at every step to ensure each batch meets recognised international standards.
Download the Jura Brochure
Discover our sterile fill-finish and biologics services at our Jura facility in Switzerland.
Aseptic Fill-Finish Facility in Jura, Switzerland
With more than 6,000 m² of facilities and more than 25 years’ experience, Adragos Jura offers customised clinical manufacturing to support your therapeutic trials.
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