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P5-6. Good Manufacturing Practice Standard for Manufacturing of Multi-structural Scaffolds for the Treatment of Large Bone Defects

Project leader: Marie-Luise Wille (Science and Engineering Faculty, QUT)
Industry partner: 3D Industries
Fig. 1: CT reconstruction of the bone defect (from left to right): scaffold design, prototype print and a patient with his surgeon after a successful implantation in August 2017
Objective:
  1. Large segmental bone defects are difficult to treat in conventional ways. Risk of infection and revision surgery likelihood is high.
  2. Currently 8 clinical cases, which were treated with a patient specific bone scaffold to regenerate bone, showed no infection or need for revision surgery needed so far. Bone regrowth has been demonstrated in the patients.
  3. Clinician-Scientist interaction and Bench-to-Bedside translation remains problematic.
Alignment within M3D Innovation:
  1. Development of a multiscale imaging and manufacturing workflow.
  2. Aligns well with plate design fixation project P5-7, biodegradable scaffolds P5-8, and P2-2 Quality Standards for AM parts.
Approach:
  1. Definition of each individual step of the bone scaffold manufacturing process.
  2. Working in close collaborations with clinicians to define shortfalls of the bench to bedside process.
  3. Development of a simplified process from clinical CT data to 3D printable models (without the Materialise Suite).
  4. Optimisation of the overall workflow from CT imaging to 3D printing.
  5. Creation of a scaffold design library suitable for different anatomical locations and surgical approaches.
Key Milestones:
  1. Definition of the key modules of a patient specific bone scaffold design.
  2. Semi-automated process of patient specific bone scaffold design from CT data.
  3. Outlook on regulatory requirements.