Jura, Switzerland
With over 20 years of experience, our Swiss facility offers a complete range of services tailored to both clinical and commercial manufacturing needs. We specialise in the aseptic production of lyophilised or liquid sterile (bio)pharmaceutical products. Our facility is ideal for the production of small clinical and commercial batches and is GMP certified, demonstrating our commitment to the highest standards of quality and safety.
Our Site
Our offerings include scale-up, technology transfer, GMP processes, and stability studies to ensure top-tier quality and compliance at every stage. By integrating technology, technical expertise, and regulatory support, we empower clients to streamline their processes from development to GMP storage, ensuring efficiency and precision.
Strong Project Management
Our robust project management system ensures proactive communication and seamless coordination, keeping every project on track from start to finish.
Flexible Batch Production
We adapt to each project’s unique needs, offering tailored solutions and adjusting timelines to ensure client satisfaction, no matter the complexity.
Additionally, we don’t impose minimum batch size, giving you the flexibility to produce exactly what you need, tailored to your specific project requirements.
Aseptic Process Simulation (APS)
We offer fully compliant APS services to ensure sterility and maintain product safety and efficacy in your manufacturing processes.
GMP Regulatory Support
We provide comprehensive GMP regulatory guidance and technical support, helping you navigate complex clinical projects with ease and ensuring compliance with top industry standards.
API Management Expertise
We specialize in handling limited quantities of valuable APIs, maximizing efficiency and ensuring top-quality results for your batches.
Our Offering
Adragos Jura offers Swiss-quality pharmaceutical solutions, combining unmatched flexibility and transparency to support your development with precision and trust.
Scale-Up
Technology Transfer
Preclinical Supply
GMP Process
GMP Clinical Batches
Release Analytics
Clinical Packaging
Stability Studies
GMP Storage
Clinical Distribution
Tech Transfer
Process Validation
GMP Commercial Batches
Release Analytics
Secondary Packaging
Serialization
On-Going Stability Studies
GMP Storage
Commercial Distribution
Our Services
We specialize in aseptic manufacturing of lyophilized or liquid sterile (bio)pharmaceutical drug products. We have a highly experienced team of 120 people working in more than 20 different professions.
Clinical Manufacturing – Phase I, II, & III
- Process Alignment with GMP
- Pilot Batch
- Scale Up
- GMP Manufacturing
- Secondary Packaging
- Randomized Labeling
- Clinical Kit Preparation
- GMP Storage
- Controlled Temperature Shipment
Commercial Manufacturing – Fill and Finish
We are specialized in two distinct dosage forms: liquid products aseptically filled and lyophilized products, both filled in vials.
Capacities:
- Aseptic Filling
- Liquid Filling
- Complex Formulation
- Peptides
- Biological Products
- Controlled Substances
- Small Molecules
- Sterile Suspensions
- Ophthalmic Products
- Placebos/Diluents
- Vials
- Lyophilizer Size (3.5 m²)
No minimum batch size is imposed. Specialized in the manufacturing of clinical batches from very small quantities of bulk solution (eg: 200-300ml).
We manufacture batches for the different phases of pharmaceutical development, from manufacturing under GMP conditions (first stage of scale-up under industrial conditions, preparation of material for preclinical studies, stability studies, etc.) to GMP manufacturing for clinical needs.
Development Services
- Freeze-Drying Cycle Development
- Manufacturing Process Development and Transfer
- Formulation Development Support
- Filter/Material Compatibility
- Client Specific Development Upon Request
Analytical Services
- HPLC-UV (assay, purity)
- UPLC-UV
- Sub-visible particle counting
- Osmolality
- Residual humidity by Karl Fischer (volumetric / coulometric)
- Spectrophotometry UV-Vis
- Spectrophotometry IR
- pH
- Visible particles
- SDS – Page
- Thin layer chromatography
- Potentiometry
- Viscosity
- TOC
- Sterility testing under isolator
- Endotoxins by kinetic turbidimetry
- Bioburden testing
- Specific germs contamination
Primary & Secondary Packaging
Primary Packaging
- The customer defined the packaging (stoppers and caps)
- Depends on the specificities of the product
Secondary Packaging
- Visual Inspection
- Labelling (manually or automatically)
Quality Control
QC activities are carried out in support of manufacturing activities at all stages of manufacturing :
- Analysis of raw materials and packaging items upon receipt and then released for use.
- In Process Controls (IPC).
- Sampling of the finished product to carry out the release testing.
Release Testing
In accordance with GMP, verification of the applicability of analytical and microbiological methods are performed to guarantee reliable and reproducible results.
a) Microbiological methods:
- Bioburden Test
- Sterility Test
b) Physico-chemical methods:
- HPLC/UPLC
- Endotoxin Test
Stability Studies
- Long-Term Stability Storage Under ICH Conditions
- Analytical Testing at Different Stability Points
GMP Batch Certification
- GMP certification of the company by Swissmedic (Swiss Health Authorities) for the production of lyophilized and liquid sterile products.
- GMP manufacturing of the first batches.
Key Information
Location: Courroux, Jura, Switzerland
SQM: 6200 m²
Foundation Year: 1999
FTE (Employees): more than 110 people working in more than 20 different professions
Certifications
EU – GMP (Swissmedic)
US – FDA
Expertise
More than 20 years of experience
Apprentices trained in 4 different areas
Meet our experts
Highly skilled and well-trained scientist specialized in clinical and commercial manufacturing.
Meet our Colleague
Dr. Ursula Bausch
Ursula Bausch has led her pharmaceutical manufacturing company for over 20 years, previously working at Pfizer and Bristol-Myers-Squibb. She holds a PhD from the University of Basel and an MBA from the University of Applied Sciences and Arts Northwestern Switzerland. Since 2023, she has been a board member of Basel Area Business & Innovation.
For a more comprehensive look into Ursula’s professional profile, connect with her on LinkedIn.
