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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.

GTP Bioways CDMO - CMC Development

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

Regulatory Compliance & Quality

We operate under EMA and FDA cGMP standards, supported by robust quality systems and an experienced QA/QC team. With a history of successful audits and client inspections, we deliver the quality assurance needed for first-in-human trials and beyond.

Cell line Development process

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

With in-house filling capacities of up to 10 000 units per batch, GTP Bioways is ideally sized to deliver your drug product in vials or pre-filled syringes.

In combining a disposable isolator with automation for filling and stoppering, our exclusive line provides greater efficiency and flexibility, allowing us to shorten timelines for drug product supply.

Cell line Development process

Discover more about GTP Bioways services

Microbial Manufacturing

Process Development

Biologics

Analytics & Formulation

Biologics

Fill & Finish