The first line will be dedicated to production using microbial systems (bacteria and yeasts). With a capacity of 300L, it will be operational in the first quarter of 2023; this will allow GTP Bioways to respond to a rapidly growing market.
GTP Bioways announces that it will become the only CDMO in France to offer a BPF (Good Manufacturing Practice) unit for the production of proteins for therapeutic or vaccine applications, as well as enzymes for the manufacture of mRNA and DNA vaccines synthetic. The GTP Bioways project won first prize in the “Capacity building” call for projects launched by the French government as part of the France Relance scheme, sponsored by the French investment bank Bpifrance. The microbial production unit project is supported by the Future Investments Program, with support of € 5.9 million ($ 6.9 million).
The second pharmaceutical manufacturing unit is designed for culturing mammalian cells at a scale of 10L. With this second unit, GTP Bioways will be able to produce small batches of proteins and antibodies, varying from a few milligrams to a few grams, for a range of applications. From the fourth quarter of 2022, the unit will be able to manufacture biomolecules for vaccines and RMPUs (Raw Materials for Pharmaceutical Use) for the production of cell therapies. This is a rapidly growing need that very few European CDMOs are currently able to meet. GTP Bioways recently won a contract for the first clinical batches of a nasally administered SARS-CoV-2 vaccine, developed by the University of Tours.
“We are part of a select group of companies in Europe capable of providing process development and manufacturing services to biotech companies working on innovative treatments,” said Eric Devic, CEO of GTP Tech. “The current biomedicine production capacity in France and in Europe is not sufficient to meet a booming demand. By investing in domestic production lines, we can respond to this situation.
The new GTP Bioways production units fit perfectly into the French government’s initiative to bring industrial activity back to France. This has been clearly demonstrated with the “Grand Défi Bioproduction” program, launched in 2020, to build a national biomedicines industry. Beyond the current circumstances with the COVID-19 pandemic, one of GTP Bioways’ objectives is to become a privileged partner of biotechnology companies developing innovative treatments. This would allow the company to contribute to the production of biopharmaceutical products in Europe, particularly in France; thus helping to strengthen the nation’s capacity to meet its own biomedical needs.
In order to be able to quickly launch these units, GTP Bioways is consulting V3ie, a subsidiary of Validapro, which will help it with the engineering of the building and its compliance with international regulations. GTP Tech, a member of the GTP Bioways group, with production sites in Toulouse and Labège, intends to double its workforce. It plans to meet the needs of this new site by strengthening its production and quality assurance teams and increasing the workforce from 45 in 2021 to nearly 100 in 2025.