Digital Technologies


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Are you on the right road to unlock the value of digital technologies?

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...

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Digital Technology Roadmap

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.

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How do you want your QC lab rocket to fly?

Quality control (QC) labs play a key role in biopharmaceutical companies to ensure product quality and patient safety. However, they have yet to achieve full digital maturity and there are areas where cost, speed, and flexibility improvements are needed. Many QC labs have started their journey to digital maturity, but the multitude of instruments often leads to a complex and fragile IT setup, which is too costly to upgrade and cannot take...

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Welcome to the MES of the future

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...

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MES of the future manifesto

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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An industry response to the Danish Medicines Agency’s questions on augmented intelligence and machine learning

The Danish Medicines Agency (DKMA) is working to define criteria for the application of artificial intelligence (AI) and machine learning (ML) across GxP-regulated areas.   To understand industry’s position, it has been gathering information using questions posed as though asked by an inspector assessing the quality of an AI/ML algorithm to control and evaluate product quality.  To form an industry response, BioPhorum gathered a...

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Regulatory: Feedback to DMKA questions to critical GXP augmented intelligence

BioPhorum response to work being conducted by The Danish Medicines Agency (DKMA) to define criteria for the application of artificial intelligence (AI) and machine learning (ML) across GxP-regulated areas. The questions  asked by the agency considered the requirements and quality of data used to build, test and validate an algorithm, and how it would respond to biases and deviations in results.

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Learn along with the cyber security team how to defend your bio-operations

While there have been advances in the cyber security protection of IT systems, the defense of OT systems is typically not as effective, or as easy to implement and enforce, which leaves the back door open to cyber-attack in many facilities. Biomanufacturing plants are just like the rest of the world, experiencing a bewildering speed of technology change and integration.  Today the difference between enterprise technology (IT) and plant floor...

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