Researcher in Residence: Data driven manufacturing

cell and gene manufacturing

In a move toward advancing Cell and Gene Therapy (C&GT) manufacturing, a cutting-edge research proposal seeks to revolutionise real-time control strategies.

In collaboration with the Cell and Gene Therapy Catapult and University College London’s Stephen Goldrick, this project is poised to harness advanced data analytics, mathematical models, and Process Analytical Technology (PAT) to propel the industry toward adaptive and data-driven manufacturing.

The C&GT industry is witnessing a paradigm shift in manufacturing processes, with a growing emphasis on capturing data through diverse sensors and PAT devices. The recent completion of an extensive PAT Consortium project by the CGT Catapult marked a significant milestone, generating vast volumes of complex and high-dimensional data. This proposal aims to elevate the utility of this data, bringing forth actionable insights through advanced data analytics.

The heart of this project lies in the exploration of advanced mathematical models, including digital twins and hybrid models, to enable adaptive and real-time control strategies. The goal is to apply these strategies across various C&GT manufacturing processes, ranging from immunotherapies and stem cells to viral vectors.

Bridging the Gap: Offline Analytics and Manufacturing Parameters
One of the primary objectives of this proposal is to quantify the predictive capacity of offline analytical devices concerning critical process parameters (CPPs) and critical quality attributes (CQAs) specific to C&GT manufacturing processes. By doing so, the project aims to bridge the gap between conventional analytical tools and real-time control, paving the way for more efficient and precise manufacturing.

Leveraging Academic Expertise for Industry Advancement:
The proposal strategically brings together expertise from academia, focusing on advanced data analysis and mathematical modelling. This collaboration aims to fully exploit the rich data resource generated by PAT strategies, propelling the C&GT sector into a new era of adaptive and data-driven manufacturing control.

Stephen Goldrick said of the project: “Our vision is to empower the C&GT industry with the tools and strategies needed for adaptive and real-time control. This isn’t just about data; it’s about transforming how we manufacture therapies critical to advancing healthcare.”

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