PROBLEM: 1 of the biggest challenges for the Pharma industry is to ensure timely and reliable access to safe, innovative, and cost-effective medicines. High-quality APIs require both consistent physical and chemical properties. The crystallisation step is critical in determining both physical properties & the final purity of the API. These properties can have a significant effect on the drug product behaviour and quality, such as blend homogeneity, drug absorption rate, dissolution and process & product robustness. Also, chemistry-specific variation including polymorphism, purity and moisture content can have a critical effect on drug product quality, bioavailability, safety and shelf life.
We have identified the following pain points among our API mfg client base.
Pain Point #1. Poor control and efficiency of the crystallization process.
Soln: SmartCrys consists of an integrated soln of PAT analysers, Mfg Intelligence, Process Automation and Data Storage and Analytics which will lead to a controlled, efficient, mfg process with the ability to quickly self-adjust process parameters, to compensate for variability in process performance thus resulting in consistent product of the appropriate quality.
Pain Point #2. Regulators are taking a closer look at data integrity industry wide.
Soln: SmartCrys enables manufacturers to conform to data integrity expectations by ensuring mfg processes records for data (generation, analytics and storage) are accurate, complete, legible, attributable, intact and maintained within their original context.
Pain Point #3. Patients are experiencing a rapidly increasing frequency of drug shortages. Better process understanding will lead to faster to market products and a more reliable, predictable supply chain.
Soln: SmartCrys will enhance process understanding and control, rapidly reducing the frequency of drug shortages.
IMPORTANT FOR SOCIETY
Equipping the EU industry with SmartCrys will enable API manufacturers to: a) safeguard product quality and safety in line with cGMP's b) increase process efficiencies, c) reduce costs, d) increase production throughput, e) facilitate quicker new product development.
OVERALL OBJECTIVES
The main objective of this project was to finalize the development of the SmartCrys advanced processing technology and facilitate a wide deployment across Europe and the rest of the world.
