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Pre-clinic studies - compliance with register of Tolerana product as a human biopharm product

Grant number: 19/09722-5
Support type:Research Grants - Innovative Research in Small Business - PIPE
Duration: March 01, 2020 - February 28, 2022
Field of knowledge:Interdisciplinary Subjects
Cooperation agreement: FINEP - PIPE/PAPPE Grant
Principal researcher:Erika da Silva Carvalho Morani
Grantee:Erika da Silva Carvalho Morani
Company:Inprenha Biotecnologia e Desenvolvimento Animal Ltda
City: Jaboticabal
Pesquisadores principais:
Marcelo Roncoletta
Assoc. researchers:Ana Cláudia Silva Braga ; Edson Crusca Junior ; Karine Minari ; Renata Prandini Adum de Matos


The Inprenha Biotecnologia has a radical innovation to present to the reproduction technologies market, which the goal is the animal efficiency and production optimization - Tolerana® (a purified recombinant protein which had shown technical viability to improve pregnancy rates into different mammal's species, including humans), and the human reproduction market the goal of this project, only with the adequacy of the purpose of the product for the species in question - for humans there is no involvement of productivity issues (population concept), but rather issues and individual rights of those seeking support to have a child, ie people with problems of fertility. This product is consequence of cooperated and successful R&D conducted, with national and international patent deposits, fact that including protection for the human species, always carried out with own resources and coming from subvention resources. Under the R&D scope, the objectives have always been focused on the technical viability of different target species, but the focus on the human market has always been sought, a fact that has an impact on regulatory issues, the main one then is the amendment of the Regulatory Body for ANVISA and no longer the MAPA, that regulates veterinary products. The regulatory requirements for human products are much larger and with particularities and often depending on consistency and agreement to international Comities. The flow of requirements defined by ANVISA for registration of products intended for human use is: (i) Request for a Feasibility Report that confers the correct regulatory framework of the product and the respective list of documentation that ANVISA requires for the reported environment; (ii) preclinical studies including Dossier reporting by "single dose (acute) and repeated dose toxicity" studies, "Reproductive toxicity", "Genotoxicity", "Local tolerance", "Carcinogenicity", "Pharmacological safety" and "Toxicokinetics"; Clinical studies in human - steps I, II, III and IV. Thus, the test model used by Inprenha Biotechnology to the hypothesis viability in different animal species, cannot be replicated to humans, therefore, like the studies reported in item (ii), essential for the continuity of the registration process of the product for use in humans, are the main objectives of this project. In order to carry out all the aforementioned studies, international normative requirements of product classified as "biopharmaceutical" will be followed, a framework more coherent with the possible international interpretations that will give the present innovation to be duly registered for opening of international market. According to the company's history, it counts on the assistance and participation of collaborating researchers with feedback and know-how. The format of the work developed so far has been very prosperous and there are no national and / or international companies that make available on the market a product similar to that presented and that have the use and form of action of the researchers proposed in this project, hence the importance of the development of the same. (AU)

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