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
  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.
  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.