NSF/FDA SIR: Defining Print Fidelity and Performance of Bioactive 3D Printed Scaffolds.

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Non-technical: Biomedical products obtained through 3D printing of degradable polymers is a promising method for the fabrication of synthetic scaffolds and implantable devices. Future biomedical implants will likely be designed specifically for each patient, personalizing the product to the specific needs of the patient. Personalized 3D printed biomedical products will be designed with patient specific geometric features. Such devices will also contain therapeutic dosages specific for each patient. However to get to the reliable production of such structures, there are several scientific challenges that need to be addressed and this award enables addressing some of these challenges. For example, when a therapeutic is encapsulated within a polymer that is 3D printed, the interactions between the therapeutic and the polymer affect the printability and the quality of the printed structure. Work carried out through this award will examine the type and amount of drugs that can be incorporated in polymers and the effects of drug incorporation on the print quality. Furthermore, the work will characterize the degradation of the 3D printed polymer scaffolds and the rate of therapeutic release from the 3D printed structures. Since such 3D printed scaffolds are proposed to be used in a biological context, the growth and behavior of cells on the 3D printed structures will be examined and any potential cytotoxicity will be evaluated. The work carried out through this award will advance the nascent field of custom designed 3D printed polymeric devices and will provide a body of knowledge for other scientists and engineers to advance the field. In addition, the award provides training for graduate and undergraduate students in an interdisciplinary and emergent STEM field.Technical: 3D printing is a potentially viable protocol for efficient manufacturing of customized biomedical devices. 3D printing medical devices addresses several desired implant features such as the need to print irregular feature shapes and sizes and the need for implant porosity and the ability to incorporate or encapsulate bioactive molecules. Increasingly, such 3D printed devices are encapsulated with bioactive small molecules, peptides or other biologically active agents. This award enables the study of dispersion of small molecule therapeutics within a recently developed solvent-free, low modulus polyester system that is suitable for 3D printing bio-scaffolds. The work will provide an understanding of the Flory-Huggins interaction parameters that affect the dispersion of small molecule therapeutics in the above described viscous polyester. The effect of such encapsulated bioactives on the print fidelity will be examined and the work will provide a foundation to predict the amount of bioactive that can be incorporated within such 3D printed scaffolds. An important part of the proposed work is to study the degradation behavior of such bioactive scaffolds and examine the release behavior of bioactives from the 3D printed scaffolds. Finally, the work will evaluate the cytotoxicity of the scaffolds and their degradation products.