The role of big data analytics in digitized manufacturing

Published: 14 May 2021
Expert Insight
Damian Marshall,
Damian Marshall
Cell and Gene Therapy Catapult, London, UK
Dr DamiAn Marshall is the director of new and enabling technologies at the Cell and Gene Therapy Catapult and has almost 20 years of industrial experience gained working for SME’s and large companies. He is responsible for providing vision, expertise and leadership to a team of ~70 scientists working with a wide range of cell and gene therapy developers. Together they are addressing some of the barriers to growth within the industry, supporting the development of new technologies and helping create an advantageous environment that gives companies working in the UK a sustained competitive advantage.
John Churchwell,
John Churchwell
Cell and Gene Therapy Catapult, London, UK
Marc-Olivier Baradez
Marc-Olivier Baradez
Cell and Gene Therapy Catapult, London, UK
Marc-Olivier Baradez is Lead Scientist in the Industrialisation team at the Cell and Gene Therapy Catapult. He has over 13 years of industrial experience in the implementation of analytical strategies for the characterisation of cell therapies. He is currently the Catapult’s Strategic Lead for its core Data programme, focusing on high-throughput data generation, data handling and analysis, innovative methodologies for Quality-by-Design and in-process controls in the context of Intelligent Manufacturing, across a wide portfolio of cell and gene therapy products and processes.Marc-Olivier’s multidisciplinary expertise lies in experimental strategies supporting high-throughput multivariate quantitative approaches, in which established and new technologies are integrated to characterise cell products and their manufacturing processes. He was previously Science Leader in Cell Metrology at LGC, the UK designated National Measurement Institute for chemical and bio-measurements. He started his industrial career as Senior Scientist at ReNeuron, where he characterised the company’s first clinical neural stem cell line for stroke therapy.

Advancement in sensor technologies driven by the FDA’s Process Analytical Technologies framework and increasingly cheap and easy access to powerful cloud computing is creating an opportunity for a digital transformation in cell and gene therapy bioprocessing. This includes the prospect of advanced process control, using connected, digitally enabled soft sensor technologies to monitor critical process variables and adapt the process in real-time to maintain product quality. This type of transformation brings with it numerous challenges, not least of which is how to handle and process the large amount of complex data required to enable informed process decision making. Here we look at how a Quality-by-Design framework for digitized manufacturing could be implemented with a particular focus on the challenges of modelling and analyzing the complex data required to control dynamic processes. Going forward, this framework, which bring together physical systems alongside digital infrastructure could act as an enabler for concepts such as Industry 4.0 within the cell and gene therapy sector.

Read now