Manufacturing Development of Biomimetic Tissue Engineering Scaffolds

In the last decade, researchers have investigated nanofiber based medical vehicles for various biomedical applications. The challenge is to produce nanofiber vehicles outside laboratory environment for clinical trial. This proposed effort is targeted at developing a cGMP compliant prototype process to demonstrate manufacturing of tissue scaffold. During PhaseI, an innovative scaffold will be made using an electrospinning process from biodegradable polymer. The scaffold will be manufactured to meet the design specifications pertaining to applications like bone regeneration, grafts, among other applications. Electrospun fibersize, web thickness, pore size, and mechanical properties will be controlled to meet design specs. An innovative sterilization method will be developed to make these scaffold sterile. During the OPTION phase, we will develop design specification for pilot machine, develop a cost model covering material, manufacturing, and return on investment for capital investment in the pilot line. The model will provide material cost during clinical trial phase. Additionally, data would be gathered for device master file and packaging methodology will be investigated for packing and shipping of tissue scaffold. The END game is to have a facility to meet the production capacity with varied capability to provide tissue scaffold material for clinical trial at military and civilian sites.