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Advances in the production of biological medicines
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Resumo(s)
Terapias biológicas, medicamentos biológicos ou biofármacos são formas diferentes de designar um tipo de agente farmacêutico que são, essencialmente, moléculas produzidas ou derivadas de organismos vivos, como proteínas, hormonas ou mesmo células.
Este tipo de produtos farmacêuticos tem vindo a ganhar cada vez mais importância e atenção por parte da indústria farmacêutica e dos seus reguladores. Não só porque são relativamente novos, mas sobretudo porque apresentam muitas vantagens quando comparados com os agentes farmacêuticos químicos “tradicionais”. Uma vez que podem ser especificamente concebidos para interagir apenas com determinadas células ou receptores celulares, apresentam oportunidades incríveis para alcançar uma seletividade e uma atividade muito maiores, aumentando assim o poder terapêutico quando comparados com os seus homólogos químicos, mas também diminuindo consideravelmente os efeitos secundários negativos indesejados. No entanto, todas estas vantagens não estão isentas de algumas desvantagens. Nomeadamente, a complexidade que confere aos biofármacos a sua especificidade também torna mais difícil a sua entrega e formulação, e a abordagem inicial para o seu fabrico, que se baseava principalmente no fabrico em lotes envolvendo demasiada intervenção humana, era insustentável com o crescimento deste sector. Por conseguinte, foram dados grandes passos para transformar os tratamentos biológicos em soluções viáveis a longo prazo.
Biological therapies, biological drugs or biopharmaceuticals are all different ways to refer to a kind of pharmaceutical agent that are, essentially, molecules produced by or derived from living organisms, such as proteins, hormones or even cells. This type of pharmaceuticals has been gaining more and more importance and attention from the pharmaceutical industry and its regulators. Not just because they’re relatively novel, but most of all because they present many advantages when compared to “traditional” chemical pharmaceutical agents. Since they can be specifically engineered to only interact with certain cells or cell receptors, they present incredible opportunities to achieve much greater selectivity and activity, therefore increasing therapeutic power when compared to their chemical counterparts, but also greatly decreasing unwanted negative side effects. However, all these advantages aren’t without some disadvantages. Namely, the complexity that grants biopharmaceuticals their specificity also makes their delivery and formulation more difficult, and the initial approach towards their manufacturing, which mostly relied on batch manufacturing involving too much human intervention, was unsustainable with the growth of this sector. Therefore, great strides have been taken to turn biological treatments into viable solutions in the long term.
Biological therapies, biological drugs or biopharmaceuticals are all different ways to refer to a kind of pharmaceutical agent that are, essentially, molecules produced by or derived from living organisms, such as proteins, hormones or even cells. This type of pharmaceuticals has been gaining more and more importance and attention from the pharmaceutical industry and its regulators. Not just because they’re relatively novel, but most of all because they present many advantages when compared to “traditional” chemical pharmaceutical agents. Since they can be specifically engineered to only interact with certain cells or cell receptors, they present incredible opportunities to achieve much greater selectivity and activity, therefore increasing therapeutic power when compared to their chemical counterparts, but also greatly decreasing unwanted negative side effects. However, all these advantages aren’t without some disadvantages. Namely, the complexity that grants biopharmaceuticals their specificity also makes their delivery and formulation more difficult, and the initial approach towards their manufacturing, which mostly relied on batch manufacturing involving too much human intervention, was unsustainable with the growth of this sector. Therefore, great strides have been taken to turn biological treatments into viable solutions in the long term.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2024, Universidade de Lisboa, Faculdade de Farmácia
Palavras-chave
Biopharmaceuticals Monoclonal antibodies CAR-T RNA Manufacturing Mestrado Integrado - 2024