3-D PRINTED POLYMER-BASED COMPOSITE SCAFFOLDS AS CARRIER FOR PROTEINS AND CELLS IN BONE HEALING AND RECONSTRUCTION

PRINTBONE is a multidisciplinary project assembling seven of Europe's leading researchers active in angiogenesis, polymer synthesis, molecular and cell biology, bioreactor technology, animal and clinical research as well as GMP cell production, 3 SMEs and 2 industrial partners to achieve the overall aim: development and establishment of cost-efficient, reliable production of innovative, advanced 3-D printed scaffolds with appropriate design for large bone healing therapy. SMEs and industrial partners will bring in knowledge in upscaling from lab to market, regulatory aspects and IP management. Strong emphasis is laid on translational research discoveries, which will transfer laboratory studies into the clinical area and marketable products. Large bone defects still represent a major challenge: There are still unmet clinical needs, especially the vascularisation of large bone defects. Furthermore, there are significant engineering challenges in the up-scaling of laboratory process designs and to establish the required GMP standards at reasonable cost. Therefore, multi-structural, large bone scaffolds are developed and manufactured by applying new technologies already tested in other markets: - development of innovative, resorbable/degradable polymers and novel composites to fit the requirements of the new manufacturing technology of 3-D printing - refinement of the scaffold raw material with a) nanodiamond particles, b) biomimetic apatite and/or c) nanoscaled fibres of cellulose. - Adaption of the already validated GMP mesenchymal stem cells (MSC) manufacturing process for application in bio-printing technology (based on ink-jet methods) and automated bioreactor technology. - Establishing a proof-of-concept for the new technology in vitro and pre-clinical research will be carried out and regulatory aspects will be addressed (EMA guidelines and EU regulations).