Graftys Platforms

Graftys is a fully integrated manufacturing and development platform

MANUFACTURING

Graftys’ manufacturing platform is a fully integrated 2,500 sq.ft manufacturing facilty located in Aix-en-Provence, Southern France. Graftys integrates all aspects of chemical synthesis and manufacturing thereby ensuring that Graftys’ products meet the highest quality standards.

Graftys has developed strong expertise in manufacturing of biomaterials, with experience and know-how in process optimization. All products are manufactured in compliance with Medical Device Directive 93/42/EEC and EN ISO 13485:2012. Graftys has produced more than 45,000 ceramics and 35,000 cement syringes since 2008.

production

R&D PLATFORM

Graftys’ R&D platform is built on a tight partnership with three major academic research organizations based:

  • In Nantes:
    • CNRS/University UMR 6230 unit headed by Pr. Jean-Michel Bouler, Research Director and acting CSO at Graftys, for analytic chemistry and chemistry developments.
    • Oniris College of Veterinary Medicine with Pr Olivier Gauthier for pre-clinical feasibility, animal model developments and clinical veterinary studies.
  • In Nice:
    • Institut de Biologie Valrose, Université Côte d’Azur, BIPOA team directed by Dr Jean-Claude Scimeca for biology of bone tissues.

Each Graftys R&D project is led through a collaborative approach by a multifunctional team which includes technical experts and clinicians. Graftys’ programs focus on unmet clinical needs in the orthopedic, spine, and dental fields and are aligned with evolving medical practice such as prevention, minimally-invasive surgery and biological repair.

Graftys’ R&D team includes nine PhDs, integrating all functional skills, competencies and know-how in Bone biology and Chemistry. Over 90 international publications* on biomaterials and 8 filed patent applications are the landmarks of the technical achievement in several high potential projects.

*List of relevant selected publications from Graftys R&D:

  1. C. Mellier, F. Fayon, V. Schnitzler, O. Gauthier, F. Boukhechba, E. Verron, D. Massiot, P. Janvier, J.-M. Bouler, Bruno Bujoli ‘Design and properties of novel gallium-doped injectable apatitic cements.’ Acta Biomater. (2015) 24:322-32.
  2. E. Verron, M-L Pissonnier, V. Schnitzler, B.H. Fellah, J. Lesoeur, P. Pilet, H. Pascal-Moussellard, O. Gauthier, J.-M. Bouler ‘Vertebroplasty using bisphosphonate-loaded calcium phosphate cement in a standardized vertebral body bone defect on an osteoporotic sheep model.’ Acta Biomater. (2014) 10(11):4887-95.
  3. J. Zhang, W. Liu, V. Schnitzler, F. Tancret, J.-M. Bouler ‘Calcium phosphate cements for bone substitution: chemistry, handling and mechanical properties.’ Acta Biomater. (2014) 10(3): 1035-49.
  4. V. Schnitzler, F. Fayon, C. Despas, I. Khairoun, C. Mellier, T. Rouillon, D. Massiot, A. Walcarius, P. Janvier, O. Gauthier, G. Montavon, J.-M. Bouler, B. Bujoli ‘Investigation of alendronate-doped Apatitic Cements as a Potential Technology for the Prevention of Osteoporotic Hip Fractures. Critical Influence of the Drug Introduction Mode on the In Vitro Cement Properties.’ Acta Biomater (2011) 7(2):759-70.
  5. T. Balaguer, F. Boukhechba, A. Clavé, S. Bouvet-Gerbettaz, C. Trojani, J-F. Michiels, J-P. Laugier, J.-M. Bouler, GF Carle, J-C. Scimeca, N. Rochet. ‘Biphasic calcium phosphate micro-particles for bone formation: benefits of combination with blood clot.’ Tissue Eng. A (2010) 16(11):3495-505.
  6. E. Verron, O. Gauthier, P. Janvier, P. Pilet, J. Lesoeur, B. Bujoli, J.
    Guicheux, J.-M. Bouler ‘In vivo bone augmentation in an osteoporotic environment using bisphosphonate-loaded calcium deficient apatite.’ Biomaterials (2010) 31(30):7776-7784.
  7. A.-M. Le Ray, H. Gautier, J.-M. Bouler, P. Weiss, C. Merle ‘A new technological procedure using sucrose as porogen compound to manufacture porous biphasic calcium phosphate ceramics of appropriate micro- and macrostructure.’ Ceramics International, (2010) 36 (1): 93-101.
  8. S. Josse, C. Faucheux, A. Soueidan, G. Grimandi, D. Massiot, B. Alonso, P.
    Janvier, S. Laïb, P. Pilet, O. Gauthier, G. Daculsi, J. Guicheux, B. Bujoli, J.M. Bouler ‘Novel biomaterials for bisphosphonate delivery.’ Biomaterials (2005) 26:2073-2080.
  9. B. Peter, D.P. Pioletti, S. Laïb, B. Bujoli, P. Pilet, P Janvier, J. Guicheux, P-Y Zambelli, J-M. Bouler, O Gauthier ‘Calcium Phosphate Drug Delivery System: Influence of local zoledronate release on bone implant osteointegration.’ Bone (2005) 36:52-60.
  10. O. Gauthier, I. Khairoun, J. Bosco, L. Obadia, X. Bourges, C. Rau, D. Magne, J.M. Bouler, E. Aguado,G. Daculsi and P. Weiss, ‘Non-invasive bone replacement using a new injectable calcium phosphate biomaterial.’J. Biomed. Mater. Res. (2003) 66A (1): 47-54
  11. O. Gauthier, J.M. Bouler, E. Aguado, P. Pilet and G. Daculsi, ‘Macroporous biphasic calcium phosphate ceramics: influence of size and percentage of macroporosity on bone ingrowth.‘ Biomaterials, (1998), 19, 133-39.
  12. S. Yamada, D. Heymman, J.M. Bouler, and G. Daculsi, ‘Osteoclastic resorption of calcium phosphate ceramics with various hydroxyapatite / ß-tricalciumphosphate ratios’, Biomaterials, (1997): 18, 1037-41.