Zebradvances Company - zebrafish research and innovation core

• Grant number: 19/22938-7
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: November 01, 2020
• End date: February 28, 2021
• Field of knowledge: Biological Sciences - Pharmacology - Toxicology
• Principal Investigator: Helena Janke
• Grantee: Helena Janke
• Company: Zebradvances Pesquisa e Consultoria em Rastreio Toxicológico Ltda
• CNAE: Fabricação de medicamentos para uso humano ; Fabricação de medicamentos para uso veterinário ; Pesquisa e desenvolvimento experimental em ciências físicas e naturais
• Associated researchers: Hirla Costa Silva Fukushima ; Ricardo Carneiro Borra ; Tatiana Correa
• Associated scholarship(s): 20/12895-6 - Zebradvances Company: zebrafish research and innovation core, BP.PIPE; 20/13198-7 - Acute toxicity and teratogenicity index of reference compounds to Zebrafish embryos and larvae, BP.TT

Abstract

Pharmaceutical, agrochemical, food and other industries require toxicological safety assessment methods to ensure quality control of raw materials, products being marketed and new products for success in the regulatory steps. Currently, the tests used for toxicological screening are expensive, time consuming and not satisfactorily predictive. Aiming to address this problem, Zebradvances Company proposes a fast, economic and predictive toxicological screening program to assess adverse effects on human, animal and environmental health. Our methodology involves toxicological testing with the alternative Zebrafish model (embryos and larvae). Testing with Zebrafish model has many advantages compared to conventional in silico and in vitro models, mainly due to the high degree of genetic similarity to human (~70%) and to the absorption, distribution and excretion system (ADME) of a complete organism. The objectives to be achieved for this proposal include the validation of endpoint assessment methodologies required for toxicological screening according to Food and Drug Administration (FDA) requirements such as acute, cardiac, hepatic, genic, neuro and immunological toxicity. The toxicological testing methodologies described in the literature will be validated, such as: Guideline OECD 236 (Fish Embryo Acute Toxicity (FET) Test); Guideline ABNT 15499; cardiotoxicity evaluation by altering cardiac parameters in 48 hpf embryos and 96 hpf larvae, with the aid of CardioCount v.01 software; hepatotoxicity evaluation according to two phenotypic liver outcomes using the Oil Red O staining method; genotoxicity evaluation by the Comet test; neurotoxicity by neurobehavioral biomarker evaluation (spontaneous movement), with the aid of ESPMOV Count v1.0 software; immunotoxicity by neutrophil migration. Enabling and ensuring the validation of the proposed methodologies, Zebradvances Company intends to demonstrate the technical and predictive capability of the complete Zebrafish screening program sharing with its potential clients and partners. (AU)