The proposed Innovation Project aims to develop and commercialise the world’s first Self-Guided Fluidised Bed Granulation Solution targeted at the pharmaceutical, food, nutritional and cosmetics industries. The SMART-GRAN solution will incorporate a suite of Process Analytical Technology (PAT) analysers for the in-process monitoring and closed loop control of the Critical Process Parameters (physical, chemical and moisture properties of the granulate) coupled with soft-sensoring, for obtaining consistent product quality and safety. The ability of the system to confirm cleaning process success between batches will reduce equipment downtime, increase product throughput and lead to increased productivity. Through a cloud-based data management platform, the SMART-GRAN solution will enable historical data to be available for Quality-by-Design process optimisation for gaining resource efficiencies for improved competitiveness. This will enable intelligence-based manufacturing (IbM) concepts which focus on harnessing the complementary power of data, modelling, engineering and IT infrastructure by transforming data into knowledge and ultimately intelligence, to equip industry to move to proactive manufacturing strategies that deliver predictable manufacturing performance. The commercialization of the system will help IPL to secure a position as a global PAT-based solutions provider to the pharmaceutical sector, generating > € 34 M in additional turnover for the company by 2022, and leading directly to the creation of ~58 new high-end jobs through the supply of the system. Roll out to other sectors will treble this potential. Moreover, the competitive impacts upstream and downstream will lead to the creation of up to ~1000 new jobs in Europe.

The project aims to address key challenges of the pharmaceutical industry related to the consistent supply of active pharmaceutical ingredients (APIs) which are formed through crystallisation processes. Over 80% of the worlds API’s have crystallisation steps. The current method of determining process performance is a combination of off-line analysis of the quality attributes of the API crystals after the crystallisation process is complete. This methodology does not control the manufacturing process and leads to a variable quality product, variable yields and a large proportion of rework batches, costing the API industry in excess of €10B/year. SmartCrys is an integrated solution for API processing issues of (1) in-line PAT Analysers to measure the critical quality attributes of the crystals, (2) Manufacturing Intelligence to interpret the data and decide whether process adjustments are required, (3) Process Automation which enable the automatic adjustment of the process to take place and (4) Data Analytics which enable visibility of all process data in real-time. SmartCrys enables rapid process development and subsequently self-adjustment of crystallization processes in real time, targeting an addressable market for SmartCrys of €20B. Through engagement with its customer base (8 of the top 10 Pharma companies worldwide) and the regulators, Innopharma have identified a technological gap in in-line process control among API manufacturers. SmartCrys will consolidate Innopharma’s position as one of the world’s leaders in Advanced Analytical Technologies within the pharmaceutical sector, and provide an opportunity to increase company turnover from €8M to €23M over the next 5 years and to grow staff from 45 to 65. It will also contribute to the continued competitiveness of the European API crystallization sector and help retain thousands of high-tech API manufacturing jobs within Europe.