The Centre for Process Innovation has announced a collaboration with major pharma players GSK and AstraZeneca to create a continuous wet granulation manufacturing facility oral solid dosage pharmaceuticals.
Collaboration
The facility is being built as part of the Prospect CP project and will include a range of services including blending and feeding raw materials, twin screw wet granulation, drying and ultimately tabletting.
The facility is being designed to include integrated in-line process analytical technologies (PAT) to monitor important in-process attributes in real-time. The suite of sensors, which are placed at the end of the granulator, generate data used to build predictive models of finished product attributes.
Once complete, it’s hoped that the facility will serve the UK pharmaceutical industry as it will be ideal to the rapid development of robust processes, potentially enabling reduced development timelines.
The facility could also be used to assist real-time monitoring and control of product quality. A longer-term ambition is to remove the need for labour intensive testing of products at the end of manufacture and decreasing drug release timeframes.
Graeme Cruickshank, director of formulation at CPI said: “We are delighted that CPI has been able to support this massive step forward in the understanding of complex particles. Creating the infrastructure needed to develop UK-led fundamental learning in this high value area will enable us to drive innovation forward in the pharmaceutical sector, as well as many others.
Jason Crooks, director, drug product design and development at GSK, added: “GSK is proud to be working with CPI to develop the Prospect CP platform. The work progressed on Prospect CP over the next two years will provide a much-needed springboard to accelerate incubation and translation of emerging process analytical technologies to the pharma business.”
Kevin Sutcliffe, principal scientist, global product development at AstraZeneca, said: “Creating the PAT test bed on the Prospect CP platform will enable industry to acquire process data using new and existing analytical technologies. Our collaboration with CPI will complement our own work in AstraZeneca on building models that show the relevance of raw material characteristics and process measurements to product quality. We look forward to seeing the outputs of this new collaborative venture.”