Systems-based Bioprocess Development

Abstract

"Advanced therapies are playing an increasingly important role in healthcare, and have huge potential to improve the health outcomes and wellbeing in society amidst the growing requirements of aging populations. However, their growing application and importance is limited by their complexity, long times to market, high development costs and large regulatory burden which contribute to substantial costs to individuals and society which limits access to these medicines.

To address these issues, a key direction for the industry is to move from experiment-hungry Quality by Testing (QbT) to predictive science-driven Quality by Design (QbD) for manufacturing process development (which is strongly supported by the regulators). This is exemplified by the need to understand the whole bioprocess Design Space; i.e. the region of critical process parameters (CPPs) that will result in satisfactory values of the critical quality attributes (CQAs) subject to expected biological variability, as well as the sensitivity of these relationships.

Currently, data hungry statistical techniques are used to design and analyse costly iterative experimental programmes in order to establish the bioprocess design space. This approach is time-consuming and requires a substantial amount of material. Developing unit operations in isolation often results in multiple iterations between upstream and downstream manufacturing process design, and can push the whole bioprocess design towards inefficient pathways, driving up manufacturing costs.

This project's objectives are to develop a prototype bioprocess mechanistic modelling platform to integrate, organise and guide a process systems engineering approach to the digital design of whole bioprocesses for the production of advanced therapies products. The approach allows a comprehensive holistic exploration of the design space through predictive simulation, optimisation and sensitivity analysis, leading to accelerated development, increased productivity and reduced production costs. The outcome of the project will be a first of its kind, state-of-the art in silico toolset, alongside the development of know-how and demonstrator case studies, available within a commercially available package, bringing a step change in the ability for industry to deploy process systems approaches to bioprocess design."
mmary

Lead Participant

Project Cost

Grant Offer

Process Systems Enterprise Limited, London, United Kingdom £99,643 £ 59,786

Publications

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