Driving adoption of new technologies in biopharmaceutical manufacturing

Schaefer, Edward J.; Balchunas, John; Charlebois, Timothy S.; Erickson, John C.; Hart, Roger A.; Kedia, Sandeep B; Lee, Kelvin H.

doi:10.1002/bit.28395

Cited by 3 publications

(2 citation statements)

References 13 publications

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“…Numerous barriers exist which limit the adoption of new technologies including immaturity of the technology or nontechnical reasons such as corporate culture or practice. 30 However, even in the case of nontechnical barriers, well documented examples or case studies demonstrating how a given technology can successfully be applied can be useful in lowering these barriers. Generating critical information faster is certainly necessary for making critical near real-time decisions during processing but it is not alone sufficient; that information must be linked to a well-defined decision tree which standardizes actions based on available test results.…”

Section: Rapid Microbial Testing As a Pat Toolmentioning

confidence: 99%

Integration of rapid bioburden testing into production quality management systems and process control

Ramos,

Najera,

Schaefer

2024

Biotechnology Progress

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The move to integrated continuous bioprocessing (ICB), while providing a means for process intensification, can put added strain on process analytics when conventional methods are used. For instance, traditional microbial methods provide minimal value to ICB processes given that the time required for data to become available is much longer than a typical full cycle of the manufacturing process. Although rapid microbial detection has been in discussion for over 30 years, it is still not routinely deployed in commercial biopharmaceutical manufacturing. One contributing factor is the ability to integrate this technology into a process control strategy and existing quality systems. An understanding of the capability of microbial detection technology available today can be leveraged to implement a control strategy for bioburden monitoring in real time for process intermediates. One key tenet of this proposed control strategy is the use of a “two‐tiered approach” wherein a fast (but possibly less sensitive) test is used to monitor the process and trigger further action for a second, longer duration test which is used to confirm and quantify the presence of bioburden and identify the organism. This approach, presented here alongside several case studies for microbial monitoring, can have broader application for other process analytical technologies where fit for purpose methods could be employed to establish process control alongside real time continuous processes.

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Section: Rapid Microbial Testing As a Pat Toolmentioning

confidence: 99%

Integration of rapid bioburden testing into production quality management systems and process control

Ramos,

Najera,

Schaefer

2024

Biotechnology Progress

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“…An overriding topic at the conference (and the field of biomanufacturing) was the challenges and opportunities of introducing new therapeutic platforms. This special issue starts with a publication by Schaefer et al (2023) that discuss the barriers, including technology, business, regulatory and people-driven concerns, that arise when introducing new therapeutic technologies and present enablers for reducing the gaps between advances and innovation in biopharmaceutical manufacturing and final therapy delivery to patients.…”

Section: Stem Cells and Cell Therapiesmentioning

confidence: 99%

Advanced cell technologies: Making protein, cell, and gene therapies a reality

Geada,

Roldão,

Betenbaugh

et al. 2023

Biotech & Bioengineering

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Advanced cell technologies: Making protein, cell, and gene therapies a reality Researchers and engineers came together in Lisbon at the 27th Meeting of the European Society for Animal Cell Technology (ESACT 2022), to discuss the latest advances in technologies associated with protein-based biologics production, new modalities and cell, gene, and tissue therapies. Main contributions focused on how the capabilities of production platforms can be enhanced, and how to leverage them to generate new products. Some of the advances that were presented are discussed below, including those related to cell line development, metabolic engineering, analytics, chinese hamster ovary and insect cells platforms engineering, vesicle and viral vector production, and gene and cell therapy, along with some concluding remarks on the future of this important field.

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Metaverse for Manufacturing: Leveraging Extended Reality Technology for Human-Centric Production Systems

Egbengwu,

Garn,

Turner

2025

Sustainability

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As we progress towards Industry 5.0, technological advancements are converging; this movement is realised by the increasing collaboration between humans and intelligent digital platforms and further enabled by the interactive visualisation modes provided by Metaverse technology. This research examines the practical applications and limitations of Metaverse technology providing insights into the transformative possibilities it offers for the manufacturing sector. Specifically, the research was guided by the core objective to trace the evolution of Metaverse technology within manufacturing. This study provides a comprehensive and state-of-the-art analysis of the adoption and impact of Metaverse technologies in the manufacturing sector. While previous research has explored aspects of Industry 4.0 and digital transformation, this study specifically focuses on human-centric manufacturing (human-in-the-loop) applications of Metaverse technology, including augmented reality, virtual reality, digital twins, and cyber-physical robotic systems. Findings from the systematic literature review indicate that Metaverse technologies, primarily augmented reality and virtual reality, have evolved into powerful tools in manufacturing. They are widely adopted across sectors in the industry, transforming processes such as product design, quality control, and maintenance. Augmented reality and virtual reality offer intuitive ways to visualise data and interact with digital twins, bridging the gap between physical and virtual realms in manufacturing. A roadmap and scenarios for the introduction of Metaverse technology in manufacturing are provided with suggested adoption timespans. Furthermore, the systematic literature review identified barriers hindering the wider adoption of Metaverse technology in manufacturing.

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Driving adoption of new technologies in biopharmaceutical manufacturing

Cited by 3 publications

References 13 publications

Integration of rapid bioburden testing into production quality management systems and process control

Integration of rapid bioburden testing into production quality management systems and process control

Advanced cell technologies: Making protein, cell, and gene therapies a reality

Metaverse for Manufacturing: Leveraging Extended Reality Technology for Human-Centric Production Systems

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