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Publication
Continuous versus batch manufacturing of oral dosage forms: analysis of current worldwide implementation
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Abstract(s)
Tradicionalmente, o fabrico de formas farmacêuticas orais é feito pela produção de lotes, mas nos últimos anos a indústria farmacêutica tem vindo a ser pressionada para melhorar a eficiência e qualidade de fabrico. Com o aumento da exigência por parte das autoridades reguladoras e a diminuição das margens de lucro fez com que as indústrias farmacêuticas explorassem novas tecnologias de fabrico A produção em continuo tem sido considerada uma opção alternativa à produção por lotes para muitos fabricantes, visto que, geralmente produz produtos farmacêuticos de melhor qualidade e de maior rendimento, com tempo e custos reduzidos.
Apesar dos avanços consideráveis e do incentivo por parte das autoridades reguladoras (FDA, EMA) através da emissão de diretrizes adequadas, a utilização da produção em continuo na área farmacêutica ainda é limitada devido a uma série de desafios relativos ao desenvolvimento de processo e à garantia de qualidade que têm impedido os fabricantes de adotar esta tecnologia.
Esta dissertação aborda as principais alterações relacionadas com a implementação da produção em continuo relativamente à produção por lotes e avalia o tipo de produção (produção em continuo vs produção por lotes) mais rentável tendo em conta vários fatores. São ainda apresentados e discutidos exemplos de empresas que já utilizam a produção em continuo, bem como alguns medicamentos fabricados com esta tecnologia.
Traditionally, the manufacture of oral pharmaceutical forms is performed by batch manufacturing, but in recent years the pharmaceutical industry has come under pressure to improve manufacturing efficiency and quality. With increasing requirements from regulatory authorities and decreasing profit margins, pharmaceutical companies have been exploring new manufacturing technologies. Continuous manufacturing has been considered an alternative option to batch manufacturing for many manufacturers, as it generally produces better quality and higher yielding pharmaceutical products, with reduced time and costs. Despite considerable advances and encouragement from regulatory authorities (FDA, EMA) through the issuance of appropriate guidelines, the use of continuous manufacturing in pharmaceuticals is still limited due to a number of process development and quality assurance challenges that have prevented manufacturers from adopting this technology. This thesis is focused on the main changes related to the implementation of continuous manufacturing relative to batch manufacturing and the evaluation of the most cost-effective type of production. Examples of companies already using continuous manufacturing, as well as some drugs manufactured by using this technology will be presented and discussed.
Traditionally, the manufacture of oral pharmaceutical forms is performed by batch manufacturing, but in recent years the pharmaceutical industry has come under pressure to improve manufacturing efficiency and quality. With increasing requirements from regulatory authorities and decreasing profit margins, pharmaceutical companies have been exploring new manufacturing technologies. Continuous manufacturing has been considered an alternative option to batch manufacturing for many manufacturers, as it generally produces better quality and higher yielding pharmaceutical products, with reduced time and costs. Despite considerable advances and encouragement from regulatory authorities (FDA, EMA) through the issuance of appropriate guidelines, the use of continuous manufacturing in pharmaceuticals is still limited due to a number of process development and quality assurance challenges that have prevented manufacturers from adopting this technology. This thesis is focused on the main changes related to the implementation of continuous manufacturing relative to batch manufacturing and the evaluation of the most cost-effective type of production. Examples of companies already using continuous manufacturing, as well as some drugs manufactured by using this technology will be presented and discussed.
Description
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2021, Universidade de Lisboa, Faculdade de Farmácia.
Keywords
Continuous manufacturing Batch manufacturing Cost-effective analysis Pharmaceutical industry Mestrado integrado - 2021