Biopharmaceutical supply chains have evolved beyond single-source manufacturing to a complex network of collaborations and partnerships between sponsors and contract organizations. However, the expectations for deeper integration and visibility, automation and flexibility have increased and the lack of a standard framework has led to bespoke solutions which are unsustainable. This paper explains the current approaches to connecting biomanufacturing organizations, and the key benefits of improved digital integration. It articulates principles and patterns in the form of a simple maturity model that can be used to assess current state and plan for a more digitally aligned future.
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Aug 2022 | Information Technology, News, Technology Strategy
Digital Technology Roadmap Part 1: Problem Statement “The output of the Digital Technology Roadmap will provide the wider industry with a clear path forward, defining the additional technical and regulatory development focus needed for successful implementation.” Gareth Alford, Innovation & Manufacturing Technology Lead at GSK, and a key thought leader for the BioPhorum Digital Technology Roadmap team. Can’t see the wood for the trees?Most...
Digital Technology Roadmap
Jul 2022 | Deliverable, Deliverables Report, Digital Technology Roadmap, POI - Technology Strategy, Publication, Technology Strategy
This paper outlines the foundational element that chart the course for pharmaceutical manufacturers who decide to take this journey and provides a vision of what that destination could look like in 10 years’ time. It outlines the current state of the industry, key challenges and barriers to adoption, and hints at the value that taking this journey will bring to patients, organizations and industry. This paper (which forms Part 1 of the Digital Technology Roadmap) looks at the problem statement and the work that has gone before.
Welcome to the MES of the future
Feb 2022 | Information Technology, News
Manufacturing execution systems (MES) provide many benefits to the regulated manufacturing of biological products but are not always successful in helping companies overcome their challenges of meeting demand, reducing costs and increasing quality across drug portfolios. Current approaches are also unsuitable for certain scenarios, e.g., small-scale manufacturing plants. At the same time, the biomanufacturing industry has not created a common...
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Jan 2022 | Deliverable, Deliverables Report, Information Technology, MES of the Future, POI - Information Technology, Publication
The purpose of the MES of the future manifesto is a call to action from the biomanufacturing industry to vendors of MES solutions. The manifesto articulates: the gap between the current generation of MES solutions and the needs of the biomanufacturing industry and a realistic and achievable vision for the MES of the future that will meet the needs of the biomanufacturing plants of the future. It is intended to stimulate collaboration between biomanufacturers and vendors of MES solutions that will outline roadmaps for future development.
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Sep 2020 | Cell & Gene Therapy, News
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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Sep 2020 | Cell & Gene Therapy, Information Technology, POI - Information Technology
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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Jul 2020 | Information Technology, POI - Information Technology
Most quality control labs in biomanufacturing have not yet achieved digital transformation. Lab processes are often manual which is slow and leads to errors and variability as well as long lead times.
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Jul 2020 | Information Technology, News
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