With these two new units, which will be built in Toulouse by mid-2023, the CDMO will be the only one in France offering GMP development and manufacturing services on a microbial platform, in addition to a small volume GMP mammalian platform.
The project to build two new units was launched in 2021. The first unit will open in April 2023 and will respond to the growing need for small batch manufacturing for highly potent biotherapeutics, vaccines and ancillary reagents for cell and gene therapies. The first product 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 other platform will be operational on July 1, 2023, and will be dedicated to the production of therapeutic proteins using microbial systems. 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.
From the outset, GTP Bioways’ managers have been well aware of the challenge with which they are faced. This motivates them even more. “This project is strategically positioned to respond to market needs, but it is being developed in a very complex context,” said Alain Sainsot, CEO of GTP Bioways. “It started in the midst of the Covid crisis and has continued during a worldwide geopolitical crisis, coinciding with inflation and difficulties regarding the supply and availability of components… It is a perilous but exciting equation to solve.” Fortunately, GTP Bioways enjoys the confidence of its teams, the French state, the market, its long-standing investors and its shareholders. The project will cost €12 million, of which Bpifrance will be funding half.
GTP Bioways is thus filling an important gap in the French pharmaceutical industry. “In this segment, subcontracting these types of services is rare and we are the only CDMO in France capable of offering microbial and mammalian services to develop the cell line up until the injectable stage, in a GMP environment,” Alain Sainsot added.
The company, which is located in Toulouse, in south-west France, was established in 2018. The CDMO decided from the outset to specialize in the production of biodrugs – recombinant proteins and monoclonal antibodies. “Our approach is as complete as possible. It goes from the generation of the cell line to the finished product, which is injectable in 90% of cases, and includes all the analytical methods that accompany production,” the group’s CEO said.
“Currently, France imports 95% of the supplies it needs for its immunotherapy treatments. With the opening of these two new biopharmaceutical production units in mammalian and microbial systems of expression, we are contributing to the France 2030 stimulus plan. GTP Bioways is indisputably creating one way forward in the drive for national sovereignty over healthcare,” says Alain Sainsot, CEO of GTP Bioways.
The group is growing over time, both organically and via the acquisition of other companies. A new subsidiary is being rapidly created: GTP Nano. It focuses on developing formulae for injectable nanodrugs.
In March 2019, GTP Bioways acquired GTP Technology, a company that specializes in the development of processes, cell lines and pre-clinical analytical development. “Our idea was to add clinical production capacities to the project in order to transfer the result of GTP Technology’s pre-clinical developments to GMP productions that can be injected into humans,” Alain Sainsot explains. This was achieved in December 2020 via a strategic partnership with Fareva, a French manufacturer that is the international leader in its sector. By managing its site at Saint-Julien-en-Genevois (French Alps), GTP Bioways has succeeded in incorporating it into its marketing and sales policy and in finding a GMP outlet for its manufacturing processes.
In 2021, GTP Bioways acquired GTP Immuno, which specializes in the identification and dosing of bioproduction impurities (host cell protein or HCP), providing additional expertise that is highly sought-after by biopharmaceutical companies.
On March 9, 2023, GTP Bioways announced another business partnership, this time with Texcell, a CRO (contract research srganization) which specializes in viral safety, the development of bio-trials and the production of GMP cell banks. By joining forces, the two French businesses will now be in a position to offer biopharmaceutical companies complete services, in support of the development of innovative therapies worldwide. With its offices and laboratories in France, China, Germany, Japan and the USA, Texcell will contribute an additional international footprint to the partnership.
Original article from French HealthCare: https://frenchhealthcare.fr/gtp-bioways-is-opening-two-new-biopharmaceutical-production-units/