Development of allergic mite extract for immunotherapy

• Grant number: 20/00157-0
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: November 01, 2021
• End date: November 30, 2022
• Field of knowledge: Health Sciences - Pharmacy - Medicines Analysis and Control
• Principal Investigator: Everton Salgado Monteiro
• Grantee: Everton Salgado Monteiro
• Company: Bioallergy Pesquisa e Inovação em Imunoterapia Ltda
• CNAE: Fabricação de preparações farmacêuticas
• City: Álvaro de Carvalho
• Associated scholarship(s): 21/13108-0 - Development of hypoallergenic extract (alergoid) of mites for immunotherapy, BP.TT

Abstract

The present work deals with the research and development of allergenic mite extract for allergenic immunotherapy. These pharmaceuticals, technically called immunotherapy, are used for the administration of allergenic extracts in patients with allergic diseases, with the aim of promoting clinical tolerance, reducing or eliminating their symptoms. The ANVISA, the national authority responsible for the supervision of the pharmaceutical sector, through RDC No. 194, of December 12, 2017, provides for registration and post-registration changes of Industrialized Allergenic Products, establishing criteria for this pharmaceutical branch, regulating in this way the production and marketing of allergenic pharmaceutical products. The Brazilian market for extracts and vaccines for immunotherapy is undergoing significant changes since the publication of such regulation. A very small number of allergenic extract manufacturers are observed in the sector, a material that is necessary in view of current regulations for the manufacture of immunotherapy vaccines. The problem that surrounds the sector is, firstly, regarding the quality of the products currently available, proven low quality through studies carried out and which will be elucidated in this project, another problem, is the protectionism on the extracts, being therefore a producer which has an extract registered with ANVISA, does not distribute it to pharmaceutical companies wishing to manipulate vaccines for commercialization, this makes the national market hostage to a few companies, which often associated with the international market, to bring ready-made products. In this sense, BioAllergy - Research and Innovation for Immunotherapy is born, with the objective of developing internally, and with its own process, allergenic extracts of improved potency and high quality, safety and efficacy. Thus, providing greater access for the population to treatment for allergies. (AU)