This study proposes a field study, based on a literature review, about the applications and impacts of Industry 4.0 (I4.0) in the biopharmaceutical sector. The world is facing a new industrial revolution and the central idea is the integration between the virtual and the real world through elements that will allow for a greater degree of automation and digitization of processes. The production of medicines via biological processes is a booming domain in the pharmaceutical sector, that involves extraordinary technological challenges. The fieldwork, carried out between August 2019 and February 2020, involved semi-structured interviews with managers of pharmaceutical companies and specialists in the I4.0 theme. The interviews allowed for the identification of trends and key benefits and barriers for implementing I4.0 in the biopharmaceutical sector. While the perceptions were considerably diversified, benefits in productivity, competitiveness and quality ranked among the most scored items. The main barriers, highlighted by the interviewees, refer to the need to break organizational cultural standards, the regulatory requirements, the lack of organizational strategies for implementation, and the lack of qualified professionals. This work offers a contribution to the biopharmaceutical sector and reinforces the imminent need for companies to adapt to this new reality.

The biopharmaceutical industry has specificities related to the optimization of its processes, the effectiveness of the maintenance of the productive park in the face of regulatory requirements. and current concepts of modern industry. Current research on the subject points to investments in the health area using the current tools and concepts of Industry 4.0 (I4.0) with the objective of a more assertive production, reduction of maintenance costs, reduction of operating risks, and minimization of equipment idle time. In this context, this study aims to characterize the current knowledge about the challenges of the biopharmaceutical industry in the application of prescriptive maintenance, which derives from predictive maintenance, in the context of I4.0. To achieve this, a systematic review of the literature was carried out in the scientific knowledge bases IEEE Xplore, Scopus, Web of Science, Science Direct, and Google Scholar, considering works such as Reviews, Article Research, and Conference Abstracts published between 2018 and 2023. The results obtained revealed that prescriptive maintenance offers opportunities for improvement in the production process, such as cost reduction and greater proximity to all actors in the areas of production, maintenance, quality, and management. The limitations presented in the literature include a reduced number of models, the lack of a clearer understanding of its construction, lack of applications directly linked to the biopharmaceutical industry, and lack of measurement of costs and implementation time of these models. There are significant advances in this area including the implementation of more elaborate algorithms used in artificial intelligence neural networks, the advancement of the use of decision support systems as well as the collection of data in a more structured and intelligent way. It is concluded that for the adoption of prescriptive maintenance in the pharmaceutical industry, issues such as the definition of data entry and analysis methods, interoperability between “shop floor” and corporate systems, as well as the integration of technologies existing in the world, must be considered for I4.0.

This study proposes a field study, based on a systematic literature review,about the applications and impacts of Industry 4.0 (I4.0) in thebiopharmaceutical sector. The world is facing a new industrial revolution thatis happening at a faster pace than the previous ones. The central idea is theintegration between the virtual and the real world through elements that willallow a greater degree of automation and digitization of processes Thefieldwork, carried out between July and December 2019, considered semi-structured interviews with managers of pharmaceutical companies orspecialists in the I4.0 theme. The interviews pointed out the need for thebiopharmaceutical sector to adapt to the concepts of I4.0 and identified itsmain benefits and barriers. The perceptions were considerably diversified,with the benefits in operational efficiency, productivity and quality being themost scored items. Regarding the main barriers, the most highlighted by theinterviewees were the need to break organizational cultural standards,regulatory requirements, the lack of organizational strategies forimplementation and the lack of qualified professionals. In conclusion, thiswork in progress is a contribution to the biopharmaceutical sector andreinforces the imminent need for companies to adapt to this new reality.

O artigo trata da elaboração de um Plano Diretor de Digitalização (PDD) para uma nova fábrica de Bio-Manguinhos/Fiocruz que será destinada ao processamento final de vacinas e biofármacos, baseado nas ferramentas tecnológicas propostas pela Indústria 4.0 (I.4.0) e que considera os conceitos de Fábrica Inteligente (Smart Factory). O Complexo Industrial para Biotecnologia em Saúde (CIBS) aumentará significativamente a capacidade da instituição no atendimento ao Sistema Único de Saúde brasileiro e às emergências sanitárias globais. Para tanto, é fundamental que o CIBS esteja na fronteira tecnológica do setor biofarmacêutico mundial. Um projeto de digitalização bem-sucedido envolve fatores além da implantação das tecnologias em si, tais como cultura organizacional, gestão de mudança, profissionais capacitados, dentre outros. Assim sendo, a metodologia proposta considerou diversas etapas, tais como identificação de gaps a partir de uma detalhada análise de maturidade digital da organização, critérios para seleção e priorização dos programas a serem implantados, avaliação de viabilidade financeira deles e, por fim, a construção de um roadmap de digitalização (PDD) contemplando todos esses aspectos de forma holística. Este pode ser considerado um trabalho fundamental para que o CIBS tenha uma jornada de digitalização planejada, organizada e estruturada rumo à construção de uma fábrica moderna e inteligente.

Esse trabalho consiste em um estudo sobre o panorama atual do setor de produção de biomedicamentos, em especial quanto ao movimento de desverticalização identificado em empresas da área, buscando entender como esse processo está ocorrendo, em que parte do ciclo produtivo ele está se dando mais frequentemente e que fatores e circunstâncias estão impulsionando esse fenômeno. A decisão entre fazer internamente ou terceirizar uma atividade pode ser considerada altamente estratégica para uma companhia, sobretudo quando se trata de atividades finalísticas. Nesse contexto, estão surgindo cada vez mais empresas do tipo CMO (Contract Manufacturing Organization), especializadas na prestação de serviços de produção. A metodologia de pesquisa utilizou como principais fontes as informações coletadas em revisão sistemática da literatura e as percepções obtidas em entrevistas semi-estruturadas realizadas em campo com especialistas que atuam no alto escalão das principais organizações da área.