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The essential digital capabilities for CGT manufacturing to succeed at scale

Cell and gene therapies (CGTs) is an emerging, high-growth area, but their manufacture is different from established small molecule and biologics platforms in many ways. These range from starter cell variability and traceability for patient safety, to the need for fast turnarounds, very dynamic scheduling and rapid deviation management. All of these, and more, profoundly affect the IT system requirements for CGT. As more CGTs are approved for...

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IT for CGT: Digital capabilities for cell and gene therapy

There are many differences in manufacturing cell and gene therapies (CGTs) compared to established small molecule and biologics platforms and this profoundly affects the IT systems requirements. Some products are personalized so the process includes personal screening and sequencing data, with traceability and data privacy throughout. Starter cell variability adds complexity to a manufacturing process that must have a rapid turnaround, very dynamic scheduling and rapid deviation management. Outcomes must be tracked for the long term to improve patient outcomes as well as to support novel reimbursement models.Industrialization of CGTs therefore needs the support of advanced systems for manufacturing execution, orchestration, traceability, scheduling, patient data and outcome tracking. Some processes will be encapsulated in closed systems, and there may be analytical requirements for continuous process verification and dynamic adjustment. Operators distributed across the globe will be supported remotely by augmented and virtual reality technologies. This paper helps executives and IT professionals to understand the IT needed to support CGT manufacture, and stimulates collaboration across the industry to meet these challenges.

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Plug and play: The value of plug-and-play automation in single-use technology

Automation can improve efficiency, track performance, adjust operations, and liberate operators from mundane routines. Automation requires a flexible set of tools that align well with the inherent flexibility of single-use technology (SUT). Although SUT flexibility enhances a biomanufacturer’s ability to modify operations to meet the needs of today’s dynamic industry, it also increases timelines and costs related to customizing and validating automated additions. This paper presents the findings of a team of industry automation experts who are sharing their experiences and testing new automation methods, with a vision to a reusable, standardized approach that enables rapid integration of intelligent process skids.

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Robotics: Opportunities for modern robotics in biologics manufacturing

Robotic systems first started making inroads in the biopharmaceutical industry through the implementation of high-throughput automated systems for drug discovery and analytical assays. Robotic systems now are making inroads in process development with the introduction of ambr and Tecan systems. In the next few years, our industry is likely to see more applications of robotic systems, particularly mobile and collaborative robots in warehouse and production floors of biomanufacturing facilities.

This paper introduces potential applications for robotics in biomanufacturing, outlines the current availability of robotic systems, and calls robotics suppliers to adapt existing systems or develop new solutions for the biomanufacturing industry. It also highlights key challenges to the adoption of mobile robotics in manufacturing with the aim of getting the industry to start to address them

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Smart maintenance: digital evolution for biopharmaceutical manufacturing

The pressures to achieve more with less in the world of equipment and facilities maintenance has always been there, but what part can smart maintenance and the use of digital technologies do for us? What would an investment deliver in terms of lower costs and improved asset utilisation? This paper defines what ‘smart maintenance’ means to the biopharma industry and how to measure its maturity. It showcases a tool to assess ways of working and level of digital maturity, by mapping to BioPhorum’s ‘Digital Plant Maturity Model’. It will help you and your organisation make the case for investment and justify adopting higher levels of maintenance practice, better framing the contribution of maintenance with digital maturity transition – where to build and with which capabilities. The paper articulates the value and benefits of achieving the higher digital maturity levels for smart maintenance, such as improved asset utilization and management, cost reduction and elimination of unplanned activities. The paper includes a discussion on ‘next-generation’ analytics, describing how current and future analytics packages can integrate with data solutions and the benefits they can bring to the smart maintenance approach.

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Plug and play workshop

A lack of equipment and automation standardization can cause a whole host of problems in the setup and reconfiguration of mAb drug substance manufacturing systems. For example, automation is often on the critical path for a facility build and the bespoke nature of interfaces means timelines can be long and uncertain. And once a facility is built it can be very difficult to switch technologies, meaning new processes are hard to adopt. It is also...

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Digital plant maturity model (DPMM) version 2: A best practice guide to using the BioPhorum DPMM and assessment tool

What does the concept of ‘digital plant’ mean in biopharmaceutical manufacturing? How can it be defined, measured and transformed? What is needed to move up the maturity curve. These are all questions that a business needs to answer to establish a practical strategy to realize the opportunities that digital offers.

The biomanufacturing Digital Plant Maturity Model (DPMM) describes the stages of maturity from simple paper-based plants through to the fully automated and integrated ‘adaptive plant’ of the future. Combined with the maturity assessment tool the maturity model can help IT professionals and stakeholders establish the current digital maturity of a biopharmaceutical facility and facilitates agreement on the future state, goals and strategy to get there.

This second version increases consistency by leveling scores across dimensions; simplifies the model by reducing the number of enabling dimensions; and improves its utility by resetting the vision for levels 4 and 5, aligning them with the BioPhorum Technology Roadmap.

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Digital plant maturity model (DPMM): assessment tool

What does the concept of ‘digital plant’ mean in biopharmaceutical manufacturing? How can it be defined, measured and transformed? What is needed to move up the maturity curve. All are questions that a business needs to answer to establish a practical strategy and realize the opportunities that digital offers.

The biomanufacturing Digital Plant Maturity Model (DPMM) describes the stages of maturity from simple paper-based plants through to the fully automated and integrated ‘adaptive plant’ of the future. The maturity assessment tool can be used alongside the model. Using the characteristics provided for each dimension of the model, an assessment can be made of a plant or a network of plants against the five digital maturity levels against eight dimensions. The maturity model and provides the language and mechanism for having the right conversations with the right stakeholders and the Assessment Tool ensures a neutral assessment of the current state, and facilitates agreement on the future state.

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Biomanufacturing technology roadmap: 1. Executive summary

Current trends in the biopharmaceutical industry, continued market growth, new product groups, cost pressures and the trend towards localized manufacturing exert unprecedented pressure on biomanufacturers to innovate biomanufacturing platforms. To accelerate the industry’s journey, a technology roadmapping process has been established to determine common biomanufacturer needs and to share them openly with supply partners, academics, regulators and government agencies so that directions can be aligned and collaboration enabled. The first edition biomanufacturing technology roadmap, published in 2017 is an initial step, setting a broad vision for the future of biomanufacturing and designed to catalyze industry action. This executive summary brings together the conclusion and recommendations of each part of the roadmap, overview, process technologies, automated facility, modular and mobile, in-line monitoring and real-time release, knowledge management, supply partner management and details the overarching next steps for the industry and this collaboration.

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