GTP Nano leverages CEA’s NanO’up R&D facility to validate an innovative manufacturing model and produce its first batches of drugs for precision therapies
Toulouse, France, October 17, 2021 – GTP Nano, a contract development and manufacturing organization (CDMO) serving the pharmaceutical industry, announced the production of its first clinical batches at its Toulouse, France plant. A new entrant on the nanodrug market, GTP Nano is leveraging an original partnership with research organization CEA that includes ongoing support with nanoformulation and the development of the associated manufacturing processes, as well as with nanocharacterization.
The nanovectorization of drugs, now used in certain precision therapies, has been the subject of pharmaceutical research and development for more than two decades. The technology has the capacity to transport drugs directly to where they are needed and gradually release the active ingredients, substantially increasing efficacy while reducing undesirable side effects. The global nanomedicine market is expected to be worth hundreds of billions of dollars by 2025, with the therapeutics segment forecasted to expand at an 8.3% compound annual growth rate (CAGR) over the next five years (sources: Market Data Forecast and Mordor Intelligence).
The CDMO GTP Nano was founded in May 2018 to develop and manufacture clinical and small commercial batches of injectable nanovectorized drugs from its own production facility. The company brings agile, flexible development and manufacturing solutions to the pharmaceutical industry. The GTP Nano plant, now fully operational, can provide GMP batches and aseptic filling services for batches of up to 60 kg.
GTP Nano’s development and manufacturing solutions are backed by an R&D partnership with the CEA on drug nanovectorization, process development, and nanocharacterization technologies. GTP Nano is also teaming up with the new NanO’up R&D facility in Toulouse, which is staffed by CEA personnel and supported by CEA nanoformulation researchers in Grenoble. NanO’up offers a collaborative environment with the latest advances in academic research to fuel new innovations in medical technology. NanO’up can take lab-scale processes up to pre-production scale on equipment financed in part by the Occitanie Region.
Together, GTP Nano and the CEA have set the ambitious goal of covering the entire nanodrug value chain from lab to manufacturing plant to offer pharmaceutical companies full process development, GMP batch production, and aseptic fill and finish services.
GTP Nano’s high-performance production facility, developed in part with the support of NanO’up, will form a solid foundation for increased collaboration between GTP Nano and the CEA on high-potential new applications in oncology and vaccine therapy.
An historic partnership
The CEA has been conducting R&D in biomaterials, bioprocesses and bioengineering for more than a decade. The institute invented a lipid nanoparticle (LNP) nanovectorization technology called Lipidots®, protected by more than fifteen patents. Lipidots® technology offers stealth, targeted, biocompatible drug delivery. The CEA develops milliliter-scale nanodrug manufacturing processes, and then scales them up to a liter before they are transferred to GTP Nano for scale-up to several liters (for GMP-compliant processes) for the manufacturing of clinical and commercial batches.
About GTP Bioways
GTP Nano’s, an entity of GTP Bioways group, specialises in formulation, process development and GMP manufacturing of nanodrugs as well as fill and finish for a wide range of active pharmaceutical ingredients.
GTP Bioways is an expert and fast-growing contract development and manufacturing organisation offering unique services for the development of manufacturing processes and the manufacturing of biotherapies, antibody-drug conjugates and nanodrugs.
With development and manufacturing units located in France, GTP Bioways supports biopharmaceutical companies in the development of their innovative molecules, from R&D through to clinical trials and market.
For more information, please visit www.gtp-bioways.com
The CEA is a key player in research, development and innovation in four main areas: energy transition, digital transition, technology for the medicine of the future and defense and security. With a workforce of 20,000 people, based in nine sites equipped with very large-scale research infrastructures, the CEA actively participates in collaborative projects with a large number of academic and industrial partners, in France, Europe and worldwide.
For more information: www.cea.fr