Biologics

We specialize in the aseptic fill and finish of biologic drug products, providing comprehensive solutions tailored to clinical and small-scale commercial manufacturing. Our Jura, Switzerland facility, backed by over 20 years of expertise, ensures GMP and FDA-compliant production with the highest standards of quality and safety.

CMC Support from Clinical to Commercial

Our comprehensive CMC services cover every stage of your biologics program:

Collaboration & Transparency: Work closely with our expert teams with direct access to technical insights. 
Regulatory Expertise: Navigate global agency requirements with confidence. 
Strategic Decision-Making: Benefit from scientific expertise that ensures smart, efficient project execution. 
Proven track record in seamless bioprocess tech transfers: Efficient integration of third-party processes and flawless transfer of in-house-developed processes.

We ensure a smooth and informed journey from pre-clinical to clinical and beyond. 

Why Choose Jura for Biologics?

Custom-Tailored Solutions for Your Biologics Program 

Our scientific experts carefully craft a strategy that aligns with your needs: 
Technical requirements 
Project constraints 
Timelines 

Flexible & Scalable Manufacturing

✔ No minimum batch size – tailored production for your specific needs
Scale-up & technology transfer support
GMP-compliant process alignment from Phase I to III
Controlled temperature storage for biologic integrity

Regulatory Support

Full GMP & FDA regulatory compliance with expert guidance
Aseptic Process Simulation (APS) to ensure sterility scapes.
We ensure that all documentation meets the highest regulatory standards, facilitating seamless approvals and accelerating your path to market. 

Analytical & Quality Control Excellence

We provide extensive quality control and analytical services to maintain biologic product safety and efficacy:
HPLC, UPLC, and UV-Vis Spectrophotometry for purity testing
Endotoxin & sterility testing under isolators
Long-term stability studies under ICH conditions

Biologics Manufacturing Solutions

From clinical batch production to commercial manufacturing, we support the entire biologics lifecycle with:
Aseptic liquid & lyophilized filling
Complex formulations & peptides handling
Small-volume sterile suspensions
Primary & secondary packaging

Aseptic Fill & Finish Expertise

We offer specialized manufacturing for lyophilized and liquid sterile biologics in glass vials with a strong focus on small-batch production for clinical and commercial needs. Our aseptic processes ensure sterility, safety, and efficacy at every stage.

Download Our Brochure Now! 

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