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GTP Bioways CDMO for biologics

With this new venture, GTP Bioways will become the only CDMO in France offering both mammalian and microbial manufacturing services.

Toulouse, 24 January 2023. GTP Bioways, a leading contract development and manufacturing organization (CDMO) specialising in the production of biotherapies and nanoformulated drugs, today confirms that its new mammalian and microbial production suites will open respectively in April and July 2023.

Since kicking off the project in October 2021, GTP Bioways has been able to overcome logistical and supply-chain challenges to set a construction schedule of less than 18 months. GTP Bioways’ new production capacities are in line with the French government’s initiative to bring industrial activity back to France, embodied by the ‘Grand Défi Bioproduction’ (aiming to make France a leader in biomanufacturing in Europe and to restore France’s sovereignty in this field), and ’capacity building’ for COVID-related projects.

A “small scale” mammalian GMP production unit to be opened in April 2023

This bioproduction unit has been designed to address the growing need for small batch manufacturing for highly potent biotherapeutics, vaccines and ancillary reagents for cell and gene therapies. It will allow the production of batches from a few milligrams to a few grams. “We have sized this bioproduction unit to fill a gap in European CDMO capacities and provide an optimised cost-per-gram to pharmaceutical actors” explains Eric Devic, General Manager of GTP Bioways. Opening is scheduled for 1st April 2023, after completion of all qualification steps. First to come out of this new  facility will be a clinical batch of SARS-CoV-2 vaccine, developed by LovalTech, a French biotech company.

The only CDMO in France offering microbial GMP manufacturing

The second pharmaceutical manufacturing unit, dedicated to the production of therapeutic proteins using microbial systems, will open on 1st July 2023. GTP Bioways will then become the only CDMO in France offering a GMP (Good Manufacturing Practices) microbial unit producing proteins and enzymes for therapeutic or vaccine use. “With fermentation capacities up to 350L, our bioproduction unit has been designed to handle a wide range of bioprocesses – using bacteria or yeasts, producing the material needed for clinical trials,” says Grégori Gross, Head of operations, GMP facility at GTP Tech.

Due to the lack of available manufacturing slots at the European scale, and the increased interest in recent years for microbial platforms – because of the development of smaller complex next-generation molecules – this microbial GMP unit is already generating interest from several biopharmaceutical companies, with whom GTP Bioways is already in talks.

GTP Bioways’ bioproduction units designed to support biopharmaceutical companies during clinical development will help strengthen France’s biomedicine sector and meet the country’s needs for innovative drugs. To achieve this challenge, GTP Bioways has already increased its staff and will keep recruiting bioproduction technicians and engineers in the coming months to reach nearly 150 collaborators in 2025.

About GTP Bioways

GTP Bioways is a CDMO (Contract Development and Manufacturing Organisation) offering integrated manufacturing services to support biopharma companies from preclinical to commercial production of their innovative therapies. Our expertise and capabilities cover the manufacturing of biologics (mammalian and microbial processes), antibody-drug-conjugates, and sterile nanoformulated drug productes (vials/PFS). Drawing on our expertise in solving tough client problems, we strive to offer a tailored approach, finely tuned to overcome each specific challenge.

With development and production sites based in France, GTP Bioways supports biopharmaceutical companies aiming to develop innovative molecules, from R&D through to clinical trials. With our unique offer, we expect to generate a turnover of €25M ($23.7M) in 2023. We employ 130 staff.