The project aims to address key challenges of the pharmaceutical industry related to 1) advanced control of manufacturing processes, 2) meeting new regulatory expectations and 3) the consistent supply of high-quality active drug or active pharmaceutical ingredients (APIs) which are formed through crystallisation processes. Over 80% of the world’s API’s have at least one crystallisation step in their manufacturing process. The current method of determining process performance is a combination of both off-line analyses of the physical and chemical quality attributes of the API crystals after the crystallisation process is complete.
This methodology is outdated with no control over the manufacturing process and leads to a variable quality product, variable yields and a large proportion of reject/rework batches, costing the API industry in excess of €10B per year. The SmartCrys Technology Suite is an integrated solution of (1) in-line process analysers (PAT Analysers) to measure the physical and chemical quality attributes of the crystals, (2) Manufacturing Intelligence to interpret the measurements and decide whether process adjustments are required to achieve the required end-product quality standards, (3) Process Automation which enables the automatic adjustment of the process to take place and (4) Data Analytics which enable visibility of all process data in real-time. When combined, SmartCrys enables rapid process development and subsequently self-adjustment of crystallization processes in real-time to assure product quality on a batch to batch basis.