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Fiocruz
Fundação Oswaldo Cruz

Farmanguinhos/Fiocruz

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Insulina humana recombinante

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A partir de 2010, terá início o processo de transferência tecnológica que possibilitará a Farmanguinhos/Fiocruz produzir 50 milhões de doses de insulina humana por ano. Atualmente, o Brasil depende integralmente de importações do medicamento, utilizado no tratamento dos diabéticos, para atender às suas necessidades.

A novidade será possível graças a um convênio com o instituto ucraniano Indar para possibilitar o desenvolvimento da substância em solo nacional. O método escolhido é o da insulina recombinante, que gera um produto final mais barato e eficaz.

O acordo técnico-científico foi assinado em julho de 2006. Após um período de 40 meses de transferência tecnológica, Farmanguinhos estará capacitado a fabricar cristais de insulina e o medicamento insulina humana recombinante.

A produção deverá cobrir 50% da demanda do Ministério da Saúde, responsável pelo Programa Nacional de Assistência Farmacêutica para Hipertensão Arterial e Diabetes.

De acordo com o convênio, até que o hormônio seja desenvolvido no país, a Fiocruz vai importar do Indar as doses necessárias para abastecer o mercado brasileiro.

A tecnologia do instituto ucraniano envolve a utilização por expressão da insulina Escherichia coli transgênica. A insulina humana recombinante de Farmanguinhos é um produto de alta qualidade com excelente desempenho farmacológico, comprovado por testes rotineiros de controle de qualidade e dados de farmacovigilância emitidos pelo Ministério da Saúde da Ucrânia. A Fiocruz terá o licenciamento pleno do medicamento, inclusive para exportação na América Latina e na África.

A incorporação da tecnologia recombinante não será útil apenas para a Fiocruz ajudar a suprir as necessidades do país, mas principalmente para abrir um novo capítulo de desenvolvimento tecnológico associado, que pode dar origem a outros biofármacos.

Estima-se que existam cerca de 1 milhão de diabéticos no Brasil que dependem de insulina. Uma pessoa recebe o diagnóstico da doença a cada 2 minutos e 18 segundos no país. A previsão é de que, em 2030, haja uma população de 11,3 milhões de brasileiros com um dos tipos do diabetes.

A insulina humana recombinante é produzida biossinteticamente pela tecnologia de DNA recombinante e apresenta-se na forma de suspensão branca e leitosa. O medicamento tem absorção facilitada de glicose e, ao mesmo tempo, inibe a produção do açúcar pelo fígado.
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