Ready-to-implant bone scaffolds using supercritical fluid technology

The integration of the supercritical CO₂ sterilization and foaming of polymeric scaffolds in a single-step process was successfully achieved by BIOAEROGEL2HEAL research team. Outcomes reported by the group address one of the key technological challenges stated by the global experts in the supercritical fluid technology field. Research was published in 2 complementary articles on International Journal of Pharmaceutics journal.

On the first part of the research, a scCO₂ sterilization method achieving SAL-6 against bacterial endospores was developed and further implemented with a foaming procedure. The work carried out with international collaborators, allowed the development of a methodology to produce sterile polymeric scaffolds with suitable morphological features for their application on bone tissue can be obtained. The protocol offers excellent control during the scaffold formation, even in the case of polymers particularly challenging, such as those of low inherent viscosity, like poly(D,L-lactide-co-glycolide) (PLGA). More information can be found at https://doi.org/10.1016/j.ijpharm.2021.120801.

The second part of the research focused on the integration of both processes in a single step, thus being a cost-effective strategy to produce sterile bone scaffolds. From a further clinical prospective use, the incorporation of active pharmaceutical ingredients (APIs) of interest was successfully achieved using vancomycin, a widely use antibiotic. In addition, the sterile and vancomycin-loaded bone scaffolds were in ovo tested with outstanding biocompatibility values, thus supporting further in vivo trials. The full article can be found at https://doi.org/10.1016/j.ijpharm.2021.121362.