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Mammalian GMP Manufacturing for Biologics

With its multi-scale mammalian GMP facilities, GTP Bioways is the ideal CDMO partner to support your clinical development with the manufacturing of biotherapeutics, vaccines and ancillary reagents.

GTP Bioways CDMO - CMC Development

Flexible mammalian GMP manufacturing capabilities

GTP Bioways has extensive experience in the cGMP production of a wide variety of biotherapeutics (standard mAbs, engineered antibodies, cytokines, antibody fragments, Fc-fusion proteins, etc…) used as therapeutics, vaccines or ancillary reagents.

Our integrated services range from cell line development to drug product manufacturing and release, and are supported by expert analytical development.

With our multi-scale cGMP production suites, we can cover your needs from clinics to market.

Our mammalian GMP production capacities for clinical & commercial supply

GTP Bioways is committed to helping you move from production of your biotherapeutic in microbial system

Saint-Julien facility

The innovative design of our state-of-the art facilities allows for capacity and technological flexibility, while ensuring compliance with the strict biopharmaceutical regulations required for cGMP operations.

With production unit capacities ranging from 250 L to 1000 L, we can manufacture up to kilogram batches. Our suites are equipped with single-use technologies for the flexible production of your biologic with rapid turnaround times.

Cell line Development process

Toulouse facility

In order to offer an optimised cost per gram for applications that require small quantities of GMP material, we have designed a mammalian manufacturing facility for the production of quantities from a few milligrams up to tens of grams of recombinant proteins or monoclonal antibodies. This suite is ideally sized in particular for the manufacturing of ancillary reagents for cell therapy.

This top-notch cGMP manufacturing line is fully equipped with single-use technologies, to offer great flexibility:

  • Fully single-use vertical and wave bioreactors with working volumes ranging from 10 to 40 L.
  • Flexible chromatography equipment able to process reduced quantities (5 to 1200 ml/min)
  • TFF systems ranging from 0.1 m² to 2 m² meeting the requirements for small batch production.
Cell line Development process

In-house drug product manufacturing and drug release

Our manufacturing offer is rounded off by in-house aseptic filling capacities, allowing us to shorten timelines for drug product supply.

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

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Discover more about GTP Bioways services

Mammalian Manufacturing

Process Development

Biologics

Analytics & Formulation

Biologics

Fill & Finish