Development and preclinical validation of a wound healing device based in type I collagen

• Grant number: 23/02636-1
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: March 01, 2024
• End date: February 28, 2025
• Field of knowledge: Interdisciplinary Subjects
• Principal Investigator: Juan José Augusto Moyano Muñoz
• Grantee: Juan José Augusto Moyano Muñoz
• Company: Bio.Inn Ltda
• CNAE: Pesquisa e desenvolvimento experimental em ciências físicas e naturais
• Associated researchers: Janaina de Andrea Dernowsek ; Sônia Maria Malmonge
• Associated scholarship(s): 24/14608-5 - Development and pre-clinical validation of a dermal regenerator based on type I collagen, BP.PIPE; 24/10585-0 - Development of new dermal regenerator formulations and process quality control, BP.TT; 24/05773-2 - Development of an Animal-Free Biological Solution through Bioprinting Technology with healing action, BP.TT

Abstract

3D bioprinting is an ever-evolving technology with several promising trends. Major advances in additive manufacturing have enabled the 3D printing of biocompatible materials, cells and supporting components into complex biological tissues. These reconstituted biological structures can be used for a wide variety of applications, including the creation of replacement tissues for transplantation, organ models for disease studies and drug testing, and the production of artificial tissues for cosmetic and research applications. Despite technological advances in the area of wound healing, most of the available commercial dressings are from animal or synthetic sources, imported and costly. Therefore, developing a national animal-free, effective and more accessible technology can not only improve the quality of life of the population, but also leverage country's economy. Therefore, Quantis/Bio.inn process can be used safely in the medical field, featuring a new product for the treatment of ulcers/wounds. The present project aims to develop and validate, in a pre-clinical way, a product with healing potential using the QMatrix input, an extracellular matrix (ECM) solution - composed mainly of type I collagen -, bioidentical, produced from the 3D cultivation of human fibroblasts. ECM proteins are essential for all stages of healing, resulting in great potential for therapeutic use. After consulting Anvisa, we confirmed the inclusion of the QMatrix filler in biological products. In response, letter No. 3/2022/SEI/GGBIO/DIRE2/ANVISA states that GPBIO/GGBIO classifies the final product (filler) as a biological product, in accordance with Law No. 5.991/1973, and points to the current legislation for registration of this type of product, RDC n.º 55/2010, requiring the following non-clinical in vivo pre-clinical studies - Pharmacodynamic studies relevant to the intended therapeutic indications, and cumulative toxicity studies (repeated-dose). In addition to the characterization of the active substance, analyzing the primary, secondary, tertiary and quaternary structure, relative molecular mass, determination of biological activity, determination of the degree of purity, data on aggregates and determination of physical-chemical and immunochemical properties. It is also necessary to study in vitro the ability to heal, as well as the potential for skin irritation. The process we are developing can be used safely in the medical field, since all the inputs used are animal-free and without genetic modification, and the final product is considered bioidentical to the human. This work opens up opportunities for the development of new therapeutic approaches in the field of wound/ulcer healing using the most innovative technology in the field of tissue biomanufacturing. (AU)