Mammalian GMP Manufacturing for Biologics and Clinical Supply
At Olon , we offer mammalian GMP manufacturing engineered for biotech and pharma innovators who need reliable, compliant production of complex biologics. Our French facility spans from small-scale clinical batches to larger GMP drug substance amounts — all controlled under one roof, with deep technical expertise and flexible process options.
Mammalian GMP Capabilities in France
We handle mammalian systems from early development through to substantial GMP batches. Our facility scale includes:
Entry scale: 10 L and 40 L bioreactors for lead candidate evaluation and toxicology studies
Clinical scale: 250 L, 1 000 L and 2 000 L single-use bioreactors for Phase I/II/III supplies
Technical tools and process features:
CHO and HEK293 cell lines (stable, suspension culture)
Hybrid design: stainless steel + single-use equipment
Downstream processing including chromatography, virus clearance, UF/DF systems
Versatile purification: TFF, large capacity columns, filtration, etc.
Stringent quality control with in-process monitoring, GMP release testing
Our mammalian GMP production capacities for clinical & commercial supply
Regulatory Compliance & Quality Assurance
Every mammalian GMP batch at Olon is built on a foundation of rigorous compliance. Our QA/QC teams draw on more than 20 years of regulatory experience with EMA, FDA, and global agencies.
We provide:
Seamless integration of CMC documentation into IND and IMPD filings
Meticulous in-line review of all quality documents to avoid delays or authority queries
Cross-functional expertise across operations, QA, QC, and process development to align with regulatory expectations
Full traceability and transparency, ensuring smooth interactions during audits and dossier submissions
By partnering with Olon, you not only gain a GMP manufacturer but also a regulatory ally who helps you de-risk submissions and accelerate time to clinic.
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Frequently Asked Questions (FAQ)
What GMP batch sizes are available at Olon for mammalian expression systems?
Our mammalian GMP facility covers a broad range: 10 L, 40 L, 250 L, 1 000 L, and 2 000 L, supporting needs from early clinical studies through later-stage production.
Which mammalian cell systems can Olon support?
We have extensive expertise with CHO and HEK293 suspension cells, transferring stable cell lines into robust GMP manufacturing processes.
How does Olon support IND and IMPD submissions?
Our regulatory affairs team integrates CMC documentation directly into IND and IMPD dossiers, ensuring smooth, timely filings. We provide technical writing, document review, and regulatory guidance to help avoid delays and de-risk submissions.
What kind of regulatory compliance can I expect?
Olon France operates under EMA and FDA cGMP guidelines, with full quality oversight, validated processes, viral safety programs, and transparent QA/QC documentation.
Can Olon provide both drug substance and drug product?
Yes. Beyond mammalian GMP drug substance, we also provide aseptic fill & finish (vials and pre-filled syringes), enabling a seamless path to patient-ready material.
Are you looking for a CDMO partner to move your biotherapeutics to clinic?
Connect with our team and we will get back to you shortly.
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