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.

The project aims to increase yields of Adeno-Associated Viral (AAV) vectors for human gene therapy studies through the improved purification processes and through the adoption of continuous chromatography approaches. The project aims to develop purification processes with improved yields and robustness that can be readily scaled to those required for in-market requirements at a reduced cost of goods than is currently being achieved for these vectors, addressing the critical needs to increase the supply and costs of these medicines.

As biopharma moves to the business mainstream, the industry will increasingly need to find new ways to maintain competitiveness by ensuring affordability, quality, and delivery performance. Continuous processes have been proposed as a solution as they are scalable, offer higher productivity with reduced running times and materials usage, and require smaller footprint and less capital intense facilities. The project brings together five leading biopharmaceutical companies with UK Operations, process technology suppliers and a Catapult centre to develop an automated continuous biologics purification unit for more efficient manufacture of a wide range of biologic drugs. The new unit will consist of integrated, multiple operations running concurrently.

A multidisciplinary team are looking to develop a sensing system which can be deployed on commercial aircraft to monitor the quality of cabin air in a hope to guard against or quantify passenger exposure to toxic molecules; caused by toxins contained in bleed air which is taken from the engines to pressurise and heat the cabin. Exposure to such neuro toxins have been thought by responsible for a health condition called "aerotoxic syndrome", which in extreme circumstances has been shown to be life threatning. International legislation is being written to enforce mandatory monitoring by airliners to alert crew should the toxin be detected during flight. This said technology capable of being deployed on an aircraft does not presently exist. The team is being lead by MicroLab Devices and uses sensing technology developed by the University of Leeds to perform the detection. Analox Systems will help work-up the technology and package it ready for aircraft deployment, by Pall Europe.