Integrating Continuous Technologies Rapid Delivery of Cost Effective Biotherapeutics to Patients

Efficient and agile production of high-quality biopharmaceuticals is of the highest priority to the biopharmaceutical manufacturing industry. The advantage of integrating multiple unit operations into a continuous process has been demonstrated by a previous consortium project, based at CPI Darlington. During that project, 3 out 4 of the end-user participant companies have moved to develop their own capabilities.

The UK needs to continue to develop expertise in this area to encourage a biopharmaceutical manufacturing presence.

This project builds on the proof-of-concept system developed in previous projects and adds the next required level of configurability, automation control and process intelligence:-

* critical control automation and predictive performance to show real-time continuity of quality attributes and to predict consumable lifetime and changeover to avoid quality deviations (predictive maintenance). Next generation Advanced Process Control and Machine Learning techniques will be developed. These tools will create a vendor independent /scale independent intelligent control solution.

* optimisation of unit operation interfaces by the incorporation of 3D-printed microfluidics to reduce volumes and therefore residence time distribution. These interfaces are also a critical point for hygienic process sampling for at-line quality analytics.

* synchronising the process data generated by the system into manufacturing cost, investment required, environmental cost, production capacity and production facility requirements. These elements will be actively assessed to allow for the process to be optimised on these factors.

* extending the upstream capabilities of the system to include a perfusion bioreactor. The process will utilise a monoclonal antibody product and process from AstraZeneca. Pall Biotech will continue to support the use of equipment and consumables used in the downstream process.

The project brings together 5 biotech product companies, all with UK Operations and a Catapult centre. The output of a demonstrator hosted at a High Value Manufacturing Catapult open access centre will ensure dissemination of the performance, design, control strategies and business value of the integrated manufacturing technology.