Microbial GMP Manufacturing for Biologics and Clinical Supply
At Olon, we deliver dedicated microbial GMP manufacturing services for biotech and pharma companies developing innovative biologics. Our French GMP facility is designed for clinical and mid-scale supply, combining stainless steel and single-use technologies to flexibly support diverse microbial expression strategies.
When programs advance to larger volumes, our Olon facilities in Italy (Settimo T.se and Capua) ensure a seamless scale-up to commercial manufacturing — one of the largest microbial infrastructures in Europe.
Microbial GMP Facility
Our microbial production plant is based on a hybrid design, combining both stainless steel and single-use equipment. This flexible setup allows us to handle a wide range of processes and expression strategies:
Cytoplasmic expression – soluble proteins or inclusion bodies
Periplasmic expression – targeting proteins to the periplasm
Secreted expression – into the culture medium
Fermentation capacity: up to 350 L GMP scale.
To address the specific requirements of each process, our suites include versatile recovery and purification technologies:
Batch and continuous centrifuges
High-pressure homogenizers with temperature control
Wide range of chromatography columns
Tangential Flow Filtration (TFF) systems from 0.5 to 15 m²
Fermentation & Scale-Up Pathways
France – GMP batches up to 350 L, ideal for clinical supply and mid-scale projects.
Italy – For late-stage or commercial production, Olon Biotech provides:
Settimo T.se: 3 100 m³ total fermentation, industrial trains up to 255 m³.
Capua: 1 400 m³ total fermentation, trains up to 100 m³.
This ensures a seamless pathway from clinic to commercial supply without changing CDMO partner.
Integrated Fill & Finish Capabilities
Olon offers aseptic fill & finish as part of its end-to-end CDMO services, closely connected to microbial drug substance manufacturing.
Isolator-based aseptic filling line ensuring sterility and operator safety
Flexible formats including vials and pre-filled syringes
Batch sizes from pilot to 10 000 units — perfectly adapted for clinical trials and small-scale commercial supply
Comprehensive QC testing and GMP release integrated into our service offering
This integration helps you move faster, reduce risks, and ensure your product is ready for patients.
Frequently Asked Questions (FAQ)
What scale of microbial GMP manufacturing does Olon France offer?
We can deliver GMP batches up to 350 L at our French site, ideal for clinical supply and mid-scale projects.
How does Olon ensure scalability to commercial production?
Projects initiated in France can be seamlessly transferred to Olon’s Italian sites (Settimo T.se and Capua), which together provide more than 4 500 m³ of microbial fermentation capacity.
Can Olon support both drug substance and drug product?
Yes — beyond microbial drug substance manufacturing, we also provide aseptic fill & finish for vials and pre-filled syringes, ensuring an integrated supply chain.
What quality standards does Olon comply with?
Our facilities are fully aligned with EMA and FDA cGMP requirements and have a strong track record of successful inspections.
What types of microbial expression systems can Olon handle?
We have extensive expertise with E. coli and other microbial hosts, managing processes such as soluble protein expression, inclusion bodies, periplasmic targeting, and secreted expression.
Are you looking for a CDMO partner to move your programme to clinic?
