CPI, GlaxoSmithKline and AstraZeneca Partner in Continuous ManufacturingBy
The Center for Process Innovation (CPI), the process manufacturing arm of the UK government’s network of Catapult centers that are designed to encourage innovation in specific areas, is partnering with GlaxoSmithKline and AstraZeneca to establish a continuous wet-granulation manufacturing facility for small-scale development of oral solid dosage pharmaceuticals.
The new facility, built as part of a project called PROSPECT CP, will include blending and feeding of raw materials, twin-screw wet granulation, drying and ultimately tableting. The facility is designed to include integrated in-line process analytical technologies (PAT). This suite of analytical sensors is placed at the end of the granulator to monitor in-process product attributes in real time. Data from the in-line sensors will be used to build models, which will predict finished product attributes from the in-process measurements, enabling robust control of product quality to be achieved.
CPI is also working closely with a number of suppliers, including GEA Group, Perceptive Engineering, Siemens, Innopharma Labs, and Kaiser Optical Systems, to create the facility, which will be based at CPI’s existing facilities at NETPark, County Durham in the UK. The resource will be capable of handling a wide range of active pharmaceutical ingredients and will include equipment relevant to established continuous manufacturing technologies.
Once complete, the capability will be available as an in-line, PAT-enabled, open-innovation facility to support the UK pharmaceutical industry and potentially other industries where the development of controlled complex solid forms is critical. It will be suited for the rapid development of robust processes enabling reduced development timelines and could also be used in the future to aid real-time monitoring and control of product quality.
A prototype of the facility has been constructed, and work is continuing on the integration of sensors and controls with the manufacturing equipment.
The PROSPECT CP project builds on and complements CPI’s existing capability to study mixing and scale-up in complex liquid formulations. This follows the completion of another strategic project to support the better implementation of computer models across manufacturing processes.
These activities are funded by an Innovate UK grant that supports the National Formulation Center and the center’s strategic themes of predictive design and manufacturability, incorporating aspects of advanced modelling and PAT-enabled model-based process control to facilitate the adoption of digital manufacturing technologies across formulation development.
Source: Center for Process Innovation