NSF/FDA SIR: Fabrication and Evaluation of Bioactive and Biodegradable 3D Printed Polymer Scaffolds

University Of Akron, Akron OH

Investigators

Abstract

Non-technical Abstract: This NSF/FDA Scholar-in-Residence program award by the Biomaterials Program in the Division of Materials Research to University of Akron is aimed towards the optimization of a set of polymeric substrates that will be encapsulated with therapeutics. This project will examine how the incorporation of therapeutics within the 3D printing materials will affect their printing process and the printed structures. 3D printing has caught the imagination of scientists and non-scientists alike. It is now conceivable that future manufacturing protocols will include 3D printing as a method to manufacture engineering and medical products. The power of 3D printing becomes all the more relevant for medical products, where it may be possible to create personalized synthetic 'organs' to replace damaged or diseased organs. Such devices may also be used to deliver therapeutics at personalized dosages. However to facilitate the translation of such 3D printed devices to the clinic, several aspects need to be addressed. In addition, these studies will also examine the degradation of these polymeric structures and the rates at which the therapeutic is released. These studies will be carried out at FDA using standardized protocols that will be relevant for future FDA regulatory examinations of 3D printed scaffolds. In addition, the award will provide training opportunities to graduate students and will prepare them for careers in engineering and science. The award will also expose undergraduate and high school students to the field of 3D printing. Technical Abstract: 3D printing is rapidly emerging as an efficient method for the fabrication of personalized medical scaffolds. 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. A critical need in this area is for polymeric materials having the right set of properties that enable their printing and integration into the physiological environment. In addition, to enable optimal integration of synthetic materials in a biological environment, it is often necessary to encapsulate them with bioactive molecules. Upon printing they will be cross-linked to 'fix' the printed scaffolds. Such viscoelastic polyesters will be encapsulated with dexamethasone, an anti-inflammatory corticosteroid. Alternatively, the polyesters will be encapsulated with bone morphogenetic proteins. Earlier studies have demonstrated clinical relevance of these therapeutics. This award will examine the effect of such therapeutics on the printing process and on the printed structures, the reproducibility, biocompatibility and biodegradation of the printed structures. In addition, this study will also examine the release profile of the encapsulated bioactive materials. The methodologies adopted for the evaluation of these scaffolds will be carried out in collaboration with the FDA, and these studies are expected to help FDA in establishing protocols for analysis and evaluation of 3D printed scaffolds in general.