Development and obtainment of biofunctional polymeric cellular scaffolds for tissue engineering application as biological substitutes "in vitro"

Abstract

In Brazil, the guidelines for the use of in vitro and alternative methods have been created and published quite recently, between 2014 and 2015, through the National Network of Alternative Methods (RENAMA), National Council for Animal Experiments (CONCEA), National Agency for Sanitary Surveillance (ANVISA) and INMETRO. In addition, these guidelines are widely being implemented in various industrial segments, such as cosmetic, pharmaceutical and medical devices, also scientific / governmental spheres and funding agencies such as FAPESP. However, despite recent regulatory milestones and deadlines established in Brazil until 2019, some technological barriers remain to be overcome. Biological models for in vitro evaluation, which are praised by technologies of tissue engineering involving epidermal biological substitutes already have validated methods to replace the use of animals. These studies can be made in reconstituted models, ie, tissues produced in the lab by means of cell culture. On the other hand, the application of these technologies are not available in Brazil, for lack of existing national technology and dependence on imports. The Biosintesis Laboratory is a technological innovation company, and currently the only Brazilian company with unique laboratory for Biological Studies in vitro which acts on Good Laboratory Practice (GLP) recognized by INMETRO (reference number 43). Also in its process of technological innovation, the company achieved between 2006 and 2014, the know-how of synthesis and scaling up of PCL raw material as a biocompatible and bioresorbable biomaterial applied to tissue engineering, achieved by FAPESP funding through PIPE project phases I, II and III. Thus, from the know-how of the company and the association of these two technologies in biological models in vitro and polymeric biomaterials, the main objective of this innovation approach will establish the fundamentals of technical feasibility and evidence of concept to obtain and characterize porous polymeric membranes consisting of electrospun nanofiber of poly ([-caprolactone) (PCL), and to study their interactions with cells for designed scaffolds as biological substitutes and tissue engineering for applications in alternative technologies instead studies with animals, to attend the domestic market and to compete in the global markets. (AU)