TheraGlio - developing theranostics for gliomas.

Praxis Biopharma Research Institute SL
praxis@theraglio.eu

Praxis Biopharma Research Institute S.L. (PRAXIS) was constituted in December 2008 with the aim of gathering the R&D activities in new medicines of the pharmaceutical Praxis Group, established in Vitoria (Spain). The company is mainly devoted to the R&D activities in the field of APIs (Active Pharmaceutical Ingredients) obtained from biotechnology and biochemistry processes. PRAXIS premises, located in Vitoria, had Pharmaceutical Laboratories accredited by the Spanish Medicine and Medical Device Agency (Agencia Española del Medicamento y Productos Sanitarios, AEMPS) for manufacturing sterile own or licensed products. For this purpose, PRAXIS counts with R&D Laboratories and clean rooms to develop new Pharmaceutical Active Ingredients, Products and Processes under GMP conditions. In our new facilities, equipped with the latest technologies, we offer the development of sterile drugs for preclinical, clinical and commercial stages. The facilities include equipment for easy format changing, featuring CIP and SIP processes, resulting highly effective for small batches production. Clinical manufacturing service (Phase I, Phase II, Phase III) using Non-cGMP/cGMP and semi-automated/automated filling processes matching all the needs. Manufacturing steps include preparation of the formula, sterile filtration, preparation of primary packaging materials (e.g., cleaning, sterilization), filling and lyophilization if required - primarily biologics such as proteins and monoclonal antibodies. One of its main strategic lines is focused on regenerative medicine for the treatment of chronic wounds. PRAXIS, together with Centro de Ingeniería Genética y Biotecnología of Cuba, has developed an innovative drug based on injected EGF for treating foot ulcers stage 3 with promising healing results and under the criteria of the European Medicines Agency (EMA). PRAXIS faces also drug development for rare cancers, including glioma, using nanotechnology and biological molecules like proteins and peptides. Moreover, PRAXIS is also working in controlled release systems through PLGA microparticles and other nanoparticles (Solid Lipid Nanoparticles, Magnetic Nanoparticles, Lipid Nanovesicles), which improve therapeutic action of APIS and allow protection of biological molecules and targeting, imaging and future theragnostic of different diseases including cancer.

Main tasks attributed to the organisation: BIOPHARMA will be involved into WP2-9. It will lead the translation of results obtained at lab scale in the formulation of MBs into the clinical grade production according to European norms, and will enhance exploitation of project results. A key point for this contribution will be the modern GMP production facilities that BIOPHARMA will put at the service of the Project.