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1.
Sensors (Basel) ; 24(15)2024 Jul 28.
Artigo em Inglês | MEDLINE | ID: mdl-39123948

RESUMO

Advances in connectivity, communication, computation, and algorithms are driving a revolution that will bring economic and social benefits through smart technologies of the Industry 4.0 era. At the same time, attackers are targeting this expanded cyberspace to exploit it. Therefore, many cyberattacks are reported each year at an increasing rate. Traditional security devices such as firewalls, intrusion detection systems (IDSs), intrusion prevention systems (IPSs), anti-viruses, and the like, often cannot detect sophisticated cyberattacks. The security information and event management (SIEM) system has proven to be a very effective security tool for detecting and mitigating such cyberattacks. A SIEM system provides a holistic view of the security status of a corporate network by analyzing log data from various network devices. The correlation engine is the most important module of the SIEM system. In this study, we propose the optimized correlator (OC), a novel correlation engine that replaces the traditional regex matching sub-module with a novel high-performance multiple regex matching library called "Hyperscan" for parallel log data scanning to improve the performance of the SIEM system. Log files of 102 MB, 256 MB, 512 MB, and 1024 MB, generated from log data received from various devices in the network, are input into the OC and simple event correlator (SEC) for applying correlation rules. The results indicate that OC is 21 times faster than SEC in real-time response and 2.5 times more efficient in execution time. Furthermore, OC can detect multi-layered attacks successfully.

2.
Artigo em Inglês | MEDLINE | ID: mdl-39164115

RESUMO

The pursuit of harnessing data for knowledge creation has been an enduring quest, with the advent of machine learning and artificial intelligence (AI) marking significant milestones in this journey. Machine Learning (ML), a subset of AI, emerged as the practice of employing mathematical models to enable computers to learn and improve autonomously based on their experiences. In the pharmaceutical and biopharmaceutical sectors, a significant portion of manufacturing data remains untapped or insufficient for practical use. Recognizing the potential advantages of leveraging available data for process design and optimization, manufacturers face the daunting challenge of data utilization. Diverse proprietary data formats and parallel data generation systems compound the complexity. The transition to Pharma 4.0 necessitates a paradigm shift in data capture for manufacturing and process operations. This paper highlights the pivotal role of artificial intelligence in converting process data into actionable knowledge to support critical functions throughout the whole process life cycle. Furthermore, it underscores the importance of maintaining compliance with data integrity guidelines, as mandated by regulatory bodies globally. Embracing AI-driven transformations is a crucial step toward shaping the future of the pharmaceutical industry, ensuring its competitiveness and resilience in an evolving landscape.

3.
JMIR Pediatr Parent ; 7: e47848, 2024 Aug 08.
Artigo em Inglês | MEDLINE | ID: mdl-39116433

RESUMO

BACKGROUND: Industry 4.0 (I4.0) technologies have improved operations in health care facilities by optimizing processes, leading to efficient systems and tools to assist health care personnel and patients. OBJECTIVE: This study investigates the current implementation and impact of I4.0 technologies within maternal health care, explicitly focusing on transforming care processes, treatment methods, and automated pregnancy monitoring. Additionally, it conducts a thematic landscape mapping, offering a nuanced understanding of this emerging field. Building on this analysis, a future research agenda is proposed, highlighting critical areas for future investigations. METHODS: A bibliometric analysis of publications retrieved from the Scopus database was conducted to examine how the research into I4.0 technologies in maternal health care evolved from 1985 to 2022. A search strategy was used to screen the eligible publications using the abstract and full-text reading. The most productive and influential journals; authors', institutions', and countries' influence on maternal health care; and current trends and thematic evolution were computed using the Bibliometrix R package (R Core Team). RESULTS: A total of 1003 unique papers in English were retrieved using the search string, and 136 papers were retained after the inclusion and exclusion criteria were implemented, covering 37 years from 1985 to 2022. The annual growth rate of publications was 9.53%, with 88.9% (n=121) of the publications observed in 2016-2022. In the thematic analysis, 4 clusters were identified-artificial neural networks, data mining, machine learning, and the Internet of Things. Artificial intelligence, deep learning, risk prediction, digital health, telemedicine, wearable devices, mobile health care, and cloud computing remained the dominant research themes in 2016-2022. CONCLUSIONS: This bibliometric analysis reviews the state of the art in the evolution and structure of I4.0 technologies in maternal health care and how they may be used to optimize the operational processes. A conceptual framework with 4 performance factors-risk prediction, hospital care, health record management, and self-care-is suggested for process improvement. a research agenda is also proposed for governance, adoption, infrastructure, privacy, and security.

4.
AAPS PharmSciTech ; 25(6): 188, 2024 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-39147952

RESUMO

Currently, artificial intelligence (AI), machine learning (ML), and deep learning (DL) are gaining increased interest in many fields, particularly in pharmaceutical research and development, where they assist in decision-making in complex situations. Numerous research studies and advancements have demonstrated how these computational technologies are used in various pharmaceutical research and development aspects, including drug discovery, personalized medicine, drug formulation, optimization, predictions, drug interactions, pharmacokinetics/ pharmacodynamics, quality control/quality assurance, and manufacturing processes. Using advanced modeling techniques, these computational technologies can enhance efficiency and accuracy, handle complex data, and facilitate novel discoveries within minutes. Furthermore, these technologies offer several advantages over conventional statistics. They allow for pattern recognition from complex datasets, and the models, typically developed from data-driven algorithms, can predict a given outcome (model output) from a set of features (model inputs). Additionally, this review discusses emerging trends and provides perspectives on the application of AI with quality by design (QbD) and the future role of AI in this field. Ethical and regulatory considerations associated with integrating AI into pharmaceutical technology were also examined. This review aims to offer insights to researchers, professionals, and others on the current state of AI applications in pharmaceutical research and development and their potential role in the future of research and the era of pharmaceutical Industry 4.0 and 5.0.


Assuntos
Inteligência Artificial , Desenvolvimento de Medicamentos , Pesquisa Farmacêutica , Pesquisa Farmacêutica/métodos , Desenvolvimento de Medicamentos/métodos , Humanos , Tecnologia Farmacêutica/métodos , Descoberta de Drogas/métodos , Aprendizado de Máquina , Controle de Qualidade , Medicina de Precisão/métodos
5.
Heliyon ; 10(13): e33853, 2024 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-39050436

RESUMO

This paper explores how digital entrepreneurs' intention toward blockchain technology adoption, perception of reduced costs, and knowledge of Artificial Intelligence impact achieving UN's Sustainable Development Goals (SDGs), drawing attention from various sectors. Present study applies explanatory sequential mixed method for data collection. Moreover, to work with the dual face patterned data, PLS-SEM is used to perform quantitative analysis of the data collected from 389 digital entrepreneurs who are chosen through purposive sampling and then content analysis is performed for the qualitative data according to the explanatory sequential mixed method's rule of thumb. The study's quantitative phase shows that factors such as perceived ease of use and usefulness of Industry 4.0 technologies, knowledge of artificial intelligence (KAI), and perception of reduced cost positively influence digital entrepreneurs' intention to adopt blockchain technology (BCT). Notably, KAI has the strongest impact. In the qualitative phase, it's found that digital entrepreneurs' KAI and willingness to adopt BCT strongly align with achieving several UN Sustainable Development Goals (SDGs), suggesting BCT adoption's potential for sustainable outcomes. The outcomes of this study set a new benchmark in the domain of SDGs achievement with careful integration to Industry 4.0, AI and BCT. This study results undoubtedly instigate the digital entrepreneurs to adopt BCT in doing their start-up and convince the policymakers to set regulatory landscape with convenient environment for the utilization of BCT which then ultimately accelerates the achievement of SDGs.

6.
Sensors (Basel) ; 24(14)2024 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-39065898

RESUMO

The introduction of the Industrial Internet of Things (IIoT) has led to major changes in the industry. Thanks to machine data, business process management methods and techniques could also be applied to them. However, one data source has so far remained untouched: The network data of the machines. In the business environment, process mining, for example, has already been carried out based on network data, but the IIoT, with its particular protocols such as OPC UA, has yet to be investigated. With the help of design science research and on the shoulders of CRISP-DM, we first develop a framework for process mining in the IIoT in this paper. We then apply the framework to real-world IIoT network traffic data and evaluate the outcome and performance of our approach in detail. We find tremendous potential in network traffic data but also limitations. Among other things, due to the dependence on process experts and the existence of case IDs.

7.
Heliyon ; 10(13): e33397, 2024 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-39027599

RESUMO

While many factors have been studied as potential causes of environmental degradation, the impact of poverty and inequality has been largely overlooked in the research. The Sustainable Development Goals are aligned with the intersection of poverty, inequality, and the environment. In addition, most previous research has used carbon dioxide (CO2) emissions as a surrogate for pollution. These gaps are filled by this study, which uses ecological footprint (a comprehensive measure of pollution) and CO2 emissions to examine the effects of income disparity and poverty on environmental pollution in 13 nations. Dynamic panel Quantile regression methods are used in this study because of their resilience to various econometric problems that can crop up during the estimate process. The empirical results reveal that the whole panel's carbon emissions and ecological footprint rise when income disparity and poverty exist. When the panel is subdivided, however, we see that income inequality reduces carbon emissions and environmental footprint for the wealthy but has the opposite effect on the middle class. While high-income households see no impact from poverty on their carbon emissions, middle-income households see an increase in both. Overall, the results of this study suggest that income disparity and poverty are major factors in ecological degradation. Therefore, initiatives to reduce environmental degradation should pay sufficient attention to poverty and inequality to achieve ecological sustainability.

8.
Sensors (Basel) ; 24(13)2024 Jun 29.
Artigo em Inglês | MEDLINE | ID: mdl-39001020

RESUMO

The digitization of production systems has revolutionized industrial monitoring. Analyzing real-time bottom-up data enables the dynamic monitoring of industrial processes. Data are collected in various types, like video frames and time signals. This article focuses on leveraging images from a vision system to monitor the manufacturing process on a computer numerical control (CNC) lathe machine. We propose a method for designing and integrating these video modules on the edge of a production line. This approach detects the presence of raw parts, measures process parameters, assesses tool status, and checks roughness in real time using image processing techniques. The efficiency is evaluated by checking the deployment, the accuracy, the responsiveness, and the limitations. Finally, a perspective is offered to use the metadata off the edge in a more complex artificial-intelligence (AI) method for predictive maintenance.

9.
Fundam Res ; 4(1): 21-24, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38933844

RESUMO

Industrial Internet upgrades the traditional industrial manufacturing to digitization, networking and intellectualization era, which calls for brand-new technology supports. As a promising solution, the emergence Digital Twin (DT) offers enhanced digital mapping capability with strong feasibility, security, economic and intelligence, which fits well with the concept of Industrial Internet. In this paper, we focus on establishing a new reference architecture of DT to support the development of Industrial Internet. It is composed of three interdependent layers (i.e., physical layer, DT layer and DT networks layer) and four critical attributes (i.e., privacy, security, awareness and real-time). We illustrate our perspectives for the functionality and relationship of the three layers, and features and feasible solutions of the four attributes. With those efforts, the proposed DT architecture can provide both smart manufacturing and networked services for Industrial Internet era. Moreover, we also illustrate the relevant and open challenges. Finally, the conclusion and future perspective are pointed out.

10.
Heliyon ; 10(11): e31590, 2024 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-38841503

RESUMO

The tourism sector is presently facing new challenges resulting from the increasing digitalization of society. Boosted by industry 4.0, new tourism dynamics are emerging. Nonetheless, the real significance of this revolutionary trend and its implications still lack further development. Aiming to assess the state-of-the-art about the digital transformation on the tourism sector, triggered by the 4.0 paradigm, the present study followed a systematic literature review approach, adopting the PRISMA protocol guidelines. A total of 44 manuscripts were considered relevant for analysis. The findings illustrate that the 4.0 paradigm is being embraced from three main perspectives: the visitor-technology interaction and its influence on decision-making, the digital competencies in tourism students, and the technology penetration in different sub-sectors of the supply chain. However, studies conceptualizing the 4.0 paradigm in the tourism sector are lacking, beyond empirical research on areas such as digital skills, pros and cons of industry 4.0 technologies, and spatial consequences.

11.
Front Robot AI ; 11: 1248646, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38915371

RESUMO

This paper introduces DAC-HRC, a novel cognitive architecture designed to optimize human-robot collaboration (HRC) in industrial settings, particularly within the context of Industry 4.0. The architecture is grounded in the Distributed Adaptive Control theory and the principles of joint intentionality and interdependence, which are key to effective HRC. Joint intentionality refers to the shared goals and mutual understanding between a human and a robot, while interdependence emphasizes the reliance on each other's capabilities to complete tasks. DAC-HRC is applied to a hybrid recycling plant for the disassembly and recycling of Waste Electrical and Electronic Equipment (WEEE) devices. The architecture incorporates several cognitive modules operating at different timescales and abstraction levels, fostering adaptive collaboration that is personalized to each human user. The effectiveness of DAC-HRC is demonstrated through several pilot studies, showcasing functionalities such as turn-taking interaction, personalized error-handling mechanisms, adaptive safety measures, and gesture-based communication. These features enhance human-robot collaboration in the recycling plant by promoting real-time robot adaptation to human needs and preferences. The DAC-HRC architecture aims to contribute to the development of a new HRC paradigm by paving the way for more seamless and efficient collaboration in Industry 4.0 by relying on socially adept cognitive architectures.

12.
PeerJ Comput Sci ; 10: e2016, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38855197

RESUMO

Equipment downtime resulting from maintenance in various sectors around the globe has become a major concern. The effectiveness of conventional reactive maintenance methods in addressing interruptions and enhancing operational efficiency has become inadequate. Therefore, acknowledging the constraints associated with reactive maintenance and the growing need for proactive approaches to proactively detect possible breakdowns is necessary. The need for optimisation of asset management and reduction of costly downtime emerges from the demand for industries. The work highlights the use of Internet of Things (IoT)-enabled Predictive Maintenance (PdM) as a revolutionary strategy across many sectors. This article presents a picture of a future in which the use of IoT technology and sophisticated analytics will enable the prediction and proactive mitigation of probable equipment failures. This literature study has great importance as it thoroughly explores the complex steps and techniques necessary for the development and implementation of efficient PdM solutions. The study offers useful insights into the optimisation of maintenance methods and the enhancement of operational efficiency by analysing current information and approaches. The article outlines essential stages in the application of PdM, encompassing underlying design factors, data preparation, feature selection, and decision modelling. Additionally, the study discusses a range of ML models and methodologies for monitoring conditions. In order to enhance maintenance plans, it is necessary to prioritise ongoing study and improvement in the field of PdM. The potential for boosting PdM skills and guaranteeing the competitiveness of companies in the global economy is significant through the incorporation of IoT, Artificial Intelligence (AI), and advanced analytics.

13.
Biotechnol Adv ; 73: 108378, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38754797

RESUMO

The bioprocessing industry is undergoing a significant transformation in its approach to quality assurance, shifting from the traditional Quality by Testing (QbT) to Quality by Design (QbD). QbD, a systematic approach to quality in process development, integrates quality into process design and control, guided by regulatory frameworks. This paradigm shift enables increased operational efficiencies, reduced market time, and ensures product consistency. The implementation of QbD is framed around key elements such as defining the Quality Target Product Profile (QTPPs), identifying Critical Quality Attributes (CQAs), developing Design Spaces (DS), establishing Control Strategies (CS), and maintaining continual improvement. The present critical analysis delves into the intricacies of each element, emphasizing their role in ensuring consistent product quality and regulatory compliance. The integration of Industry 4.0 and 5.0 technologies, including Artificial Intelligence (AI), Machine Learning (ML), Internet of Things (IoT), and Digital Twins (DTs), is significantly transforming the bioprocessing industry. These innovations enable real-time data analysis, predictive modelling, and process optimization, which are crucial elements in QbD implementation. Among these, the concept of DTs is notable for its ability to facilitate bi-directional data communication and enable real-time adjustments and therefore optimize processes. DTs, however, face implementation challenges such as system integration, data security, and hardware-software compatibility. These challenges are being addressed through advancements in AI, Virtual Reality/ Augmented Reality (VR/AR), and improved communication technologies. Central to the functioning of DTs is the development and application of various models of differing types - mechanistic, empirical, and hybrid. These models serve as the intellectual backbone of DTs, providing a framework for interpreting and predicting the behaviour of their physical counterparts. The choice and development of these models are vital for the accuracy and efficacy of DTs, enabling them to mirror and predict the real-time dynamics of bioprocessing systems. Complementing these models, advancements in data collection technologies, such as free-floating wireless sensors and spectroscopic sensors, enhance the monitoring and control capabilities of DTs, providing a more comprehensive and nuanced understanding of the bioprocessing environment. This review offers a critical analysis of the prevailing trends in model-based bioprocessing development within the sector.


Assuntos
Inteligência Artificial , Biotecnologia , Biotecnologia/métodos , Internet das Coisas , Aprendizado de Máquina , Controle de Qualidade
14.
Open Res Eur ; 4: 9, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38799730

RESUMO

This paper presents an extended approach to Impact Assessment (IA) within European Union funded large-scale projects within the manufacturing domain, which may offer value to other research projects and SME organisations seeking to develop detailed organizational reporting. It details the six-phase process that forms the framework for this extended approach, demonstrating how project Outcome Indictors and impact assessment criterion can be aligned through an extensive review and integration of existing impact domains, objectives, measures and evidence sources with project documentation to provide the detailed individual impact assessment criteria for this extended IA approach. It also reports on the application of the approach in the EC-funded digital manufacturing project, European Connected Factory Platform for Agile Manufacturing (EFPF), finding that 24 of the 27 IA criteria were met or exceed, suggesting that the project made an important contribution to the EU Industry4.0 ecosystem through furthering the key priorities of Industrial Leadership, Data Integration, Uptake of New Technologies, Open Science, the Circulation of Knowledge, and a minor contribution to Climate Change Mitigation.

15.
Heliyon ; 10(10): e30661, 2024 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-38770301

RESUMO

In the era of Industry 4.0 (I4.0), automation and data analysis have undergone significant advancements, greatly impacting production management and operations management. Technologies such as the Internet of Things (IoT), robotics, cloud computing (CC), and big data, have played a crucial role in shaping Logistics 4.0 (L4.0) and improving the efficiency of the manufacturing supply chain (SC), ultimately contributing to sustainability goals. The present research investigates the role of I4.0 technologies within the framework of the extended theory of planned behavior (ETPB). The research explores various variables including subjective norms, attitude, perceived behavior control, leading to word-of-mouth, and purchase intention. By modeling these variables, the study aims to understand the influence of I4.0 technologies on L4.0 to establish a sustainable manufacturing SC. A questionnaire was administered to gather input from small and medium-sized firms (SMEs) in the manufacturing industry. An empirical study along with partial least squares structural equation modeling (SEM), was conducted to analyze the data. The findings indicate that the use of I4.0 technology in L4.0 influences subjective norms, which subsequently influence attitudes and personal behavior control. This, in turn, leads to word-of-mouth and purchase intention. The results provide valuable insights for shippers and logistics service providers empowering them to enhance their performance and contribute to achieving sustainability objectives. Consequently, this study contributes to promoting sustainability in the manufacturing SC by stimulating the adoption of I4.0 technologies in L4.0.

16.
Sensors (Basel) ; 24(10)2024 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-38794094

RESUMO

The demand for green hydrogen as an energy carrier is projected to exceed 350 million tons per year by 2050, driven by the need for sustainable distribution and storage of energy generated from sources. Despite its potential, hydrogen production currently faces challenges related to cost efficiency, compliance, monitoring, and safety. This work proposes Hydrogen 4.0, a cyber-physical approach that leverages Industry 4.0 technologies-including smart sensing, analytics, and the Internet of Things (IoT)-to address these issues in hydrogen energy plants. Such an approach has the potential to enhance efficiency, safety, and compliance through real-time data analysis, predictive maintenance, and optimised resource allocation, ultimately facilitating the adoption of renewable green hydrogen. The following sections break down conventional hydrogen plants into functional blocks and discusses how Industry 4.0 technologies can be applied to each segment. The components, benefits, and application scenarios of Hydrogen 4.0 are discussed while how digitalisation technologies can contribute to the successful integration of sustainable energy solutions in the global energy sector is also addressed.

17.
Sensors (Basel) ; 24(10)2024 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-38794102

RESUMO

Inspections of concrete bridges across the United States represent a significant commitment of resources, given their biannual mandate for many structures. With a notable number of aging bridges, there is an imperative need to enhance the efficiency of these inspections. This study harnessed the power of computer vision to streamline the inspection process. Our experiment examined the efficacy of a state-of-the-art Visual Transformer (ViT) model combined with distinct image enhancement detector algorithms. We benchmarked against a deep learning Convolutional Neural Network (CNN) model. These models were applied to over 20,000 high-quality images from the Concrete Images for Classification dataset. Traditional crack detection methods often fall short due to their heavy reliance on time and resources. This research pioneers bridge inspection by integrating ViT with diverse image enhancement detectors, significantly improving concrete crack detection accuracy. Notably, a custom-built CNN achieves over 99% accuracy with substantially lower training time than ViT, making it an efficient solution for enhancing safety and resource conservation in infrastructure management. These advancements enhance safety by enabling reliable detection and timely maintenance, but they also align with Industry 4.0 objectives, automating manual inspections, reducing costs, and advancing technological integration in public infrastructure management.

18.
J Agric Food Chem ; 72(19): 10737-10752, 2024 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-38709011

RESUMO

Digital Twins have emerged as an outstanding opportunity for precision farming, digitally replicating in real-time the functionalities of objects and plants. A virtual replica of the crop, including key agronomic development aspects such as irrigation, optimal fertilization strategies, and pest management, can support decision-making and a step change in farm management, increasing overall sustainability and direct water, fertilizer, and pesticide savings. In this review, Digital Twin technology is critically reviewed and framed in the context of recent advances in precision agriculture and Agriculture 4.0. The review is organized for each step of agricultural lifecycle, edaphic, phytotechnologic, postharvest, and farm infrastructure, with supporting case studies demonstrating direct benefits for agriculture production and supply chain considering both benefits and limitations of such an approach. Challenges and limitations are disclosed regarding the complexity of managing such an amount of data and a multitude of (often) simultaneous operations and supports.


Assuntos
Agricultura , Produtos Agrícolas , Produtos Agrícolas/crescimento & desenvolvimento , Produtos Agrícolas/genética , Agricultura/métodos , Fertilizantes/análise , Produção Agrícola/métodos
19.
Front Robot AI ; 11: 1303279, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38585258

RESUMO

Automated disassembly is increasingly in focus for Recycling, Re-use, and Remanufacturing (Re-X) activities. Trends in digitalization, in particular digital twin (DT) technologies and the digital product passport, as well as recently proposed European legislation such as the Net Zero and the Critical materials Acts will accelerate digitalization of product documentation and factory processes. In this contribution we look beyond these activities by discussing digital information for stakeholders at the Re-X segment of the value-chain. Furthermore, we present an approach to automated product disassembly based on different levels of available product information. The challenges for automated disassembly and the subsequent requirements on modeling of disassembly processes and product states for electronic waste are examined. The authors use a top-down (e.g., review of existing standards and process definitions) methodology to define an initial data model for disassembly processes. An additional bottom-up approach, whereby 5 exemplary electronics products were manually disassembled, was employed to analyze the efficacy of the initial data model and to offer improvements. This paper reports on our suggested informal data models for automatic electronics disassembly and the associated robotic skills.

20.
Cytotherapy ; 26(9): 1095-1104, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38647505

RESUMO

BACKGROUND AIMS: The production of commercial autologous cell therapies such as chimeric antigen receptor T cells requires complex manual manufacturing processes. Skilled labor costs and challenges in manufacturing scale-out have contributed to high prices for these products. METHODS: We present a robotic system that uses industry-standard cell therapy manufacturing equipment to automate the steps involved in cell therapy manufacturing. The robotic cluster consists of a robotic arm and customized modules, allowing the robot to manipulate a variety of standard cell therapy instruments and materials such as incubators, bioreactors, and reagent bags. This system enables existing manual manufacturing processes to be rapidly adapted to robotic manufacturing, without having to adopt a completely new technology platform. Proof-of-concept for the robotic cluster's expansion module was demonstrated by expanding human CD8+ T cells. RESULTS: The robotic cultures showed comparable cell yields, viability, and identity to those manually performed. In addition, the robotic system was able to maintain culture sterility. CONCLUSIONS: Such modular robotic solutions may support scale-up and scale-out of cell therapies that are developed using classical manual methods in academic laboratories and biotechnology companies. This approach offers a pathway for overcoming manufacturing challenges associated with manual processes, ultimately contributing to the broader accessibility and affordability for personalized immunotherapies.


Assuntos
Terapia Baseada em Transplante de Células e Tecidos , Robótica , Humanos , Robótica/métodos , Terapia Baseada em Transplante de Células e Tecidos/métodos , Linfócitos T CD8-Positivos/imunologia , Técnicas de Cultura de Células/métodos , Reatores Biológicos , Imunoterapia Adotiva/métodos , Receptores de Antígenos Quiméricos , Automação
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