Period 8 claim submitted

This project involves a consortium of a UK based healthcare company (GlaxoSmithKline), a UK based university (King's College London), and a European based fruit extract producer (BerryPharma). Strategic partners of GSK are also being consulted as part of this project. These include a UK based crop research institute (James Hutton Institute) and a European beverage development company (Doehler). The aim of this project is to develop novel fruit beverages with proven health benefits, by sharing plant breeding, food science and nutrition expertise held within the consortia. A number of animal studies have shown metabolic health benefits of polyphenols. This project will help deliver evidence of this effect in humans. Recent technological developments have enabled the extraction and solubilisation of fruit polyphenols, however technical challenges still exist with high acidity, bitterness and the need for integration in a high sugar base, when incorporating the current extracts into food products. A critical aim of this project will be to prove the health benefits of these fruit polyphenols in stable products that are acceptable from a sensorial and nutritional (low sugar) basis.

The aim of the project is to drive substantial cost efficiency in both drug development and drug manufacturing processes by developing commercial counter current separation technology which will allow selective purifications to be achieved at a loading of approximately 1kg/day. In contrast to high-performance liquid chromatography, counter current separations do not require expensive packing materials; are more tolerant of particulate matter and have the benefit of excellent reproducibility. The project will demonstrate the broad applicability of the technology to pharmaceutical separation problems and specific examples will be more closely examined demonstrating separation capability at scale.

Awaiting Public Project Summary

In order to underpin the competitiveness of the UK pharmaceutical industry, a step change improvement in manufacturing efficiency is needed. This project aims to deliver this for production of the largest proportion of dosage forms (tablets). The efficiency gains are targeted at improved manufacturing precision, improved productivity and improved mass yield, and will be deliverable at approximately 70% of the capital cost of conventional technology. In developing this capability, significant technical knowledge to be delivered which will enhance the offering of the equipment manufacturers who are part of our consortium. The project will use advanced manufacturing equipment, process measurement, control and information management to deliver the claimed benefits. Previous work has been fragmented; this project will deliver an integrated advanced manufacturing / product release data acquisition platform. It is proposed to set up and use test facilities to prove the feasibility of the required manufacturing platform, enabling the optimal design of a commercial plant capable of making saleable product. The key deliverables are (i) an optimised integration strategy, (ii) performance benchmarks, (iii) a de-risked design for a full scale integrated facility, and (iv) data to demonstrate design effectiveness to key stakeholders including regulatory agencies. The process uses continuous twin screw granulation, fluid bed drying, inline blending and tablet compression, whilst PAT instruments along with standard process parameters such as temperature, pressure and work input are used to monitor the stability and control the process Product release is focused around real time continuous process monitoring and control. It is based on an understanding of the process acquired during the experimental trials following DfM/QbD principles. A concept factory of the future will be designed for the layout and operation of continuous OSD pharmaceutical manufacture. Peripheral work to the above this project will also is deliver a POC continuous tablet coater that coats at a rate to compliment the continuous trial equipment and a continuous powder blender.