Before we had any PAT tools, the process was like a black box to us. We put something in and get something out without knowing what happened inside. Now, we have an ‘Eye’ to look inside that black box and see what’s going on in there.
- Background
- Project
- Solution
CHALLENGES FACED BY THE PHARMA INDUSTRY
Consistent supply of high-quality API
Ensuring timely and reliable access to safe, innovative, and cost-effective medicines for the world’s growing patient population is a big challenge for the Pharma Industry. Pharmaceutical production requires a consistent supply of high-quality Active Pharmaceutical Ingredients (APIs). API manufacturers face frequent struggles to meet this demand due to non-robust manufacturing processes, product quality issues, and failure to meet regulatory requirements, resulting in an immense commercial loss.
MOST API’S REQUIRES CRYSTALLISATION
MOST API’S REQUIRES CRYSTALLISATION
Most of the world’s pharmaceutical API’s require at least one crystallisation step during their manufacturing process. Traditionally, the quality of the crystallisation process performance is determined through an off-line sample analysis of the physical and chemical quality attributes of the API crystals, after the process is complete. At this point, it is too late to resolve any quality issues. This method of testing offers no control over the manufacturing process, resulting in variable product quality, variable yields, and a proportion of batch rejects or reworks, with heavy costs associated.
SYSTEMS AND BANDWIDTH TO MANAGE DATA
Meeting industry regulations
Data integrity is essential in the highly regulated Pharmaceutical Industry to provide traceability and ensure drugs are made and tested to specified quality standards. During product development and manufacturing, a vast amount of process and analytical data is generated, and so effective management of this data is essential for regulatory compliance.
FAST AND RELIABLE API SUPPLY
Addressing drug shortages
The world’s patient population is experiencing an increased frequency in drug shortages. Higher global demand, combined with a short supply of raw materials, manufacturing problems, and delayed quality approvals, are affecting the supply chain. Greater process understanding and control of both API and drug product development and manufacturing throughout the product lifecycle would ensure final product quality, greatly reducing supply issues and enabling faster-time-to-market.
SMARTCRYS TECHNOLOGY SUITE
Data-driven crystal manufacturing
Innopharma works with 8 of the world’s top 10 Pharmaceutical companies and frequently engages with Regulatory and Government leaders on the adoption of Advanced Manufacturing within the industry. Innopharma has identified a technological gap in the area of in-line process control among its API manufacturing client base. The SmartCrys Technology Suite addresses critical challenges faced by the industry.
CLOUD-BASED MANUFACTURING INTELLIGENCE
Vertically integrated solution
The SmartCrys Technology Suite is an integrated solution comprising the following components; the Crystallisation Vessel Suite, PAT analysers, Data Analytics Tools, a Process Automation module, Cloud Storage, and a Manufacturing Intelligence dashboard. SmartCrys enables rapid process development and automated control of the crystallization process, facilitating real-time adjustment of key parameters in response to deviations, ensuring the process stays on the ideal path.
COMPARISON TO EXISTING TECHNOLOGIES
A complete solution
Current state-of-the-art process analytical technologies independently monitor different aspects of a crystallisation process. However, they do not offer a holistic solution to manufacturing process control as required by industry and the regulators. As these are independent technologies, it is difficult to prove that regulatory compliance concerning data integrity is achieved, as data is transferred between technologies from various suppliers. SmartCrys addresses these concerns, offering a complete solution for the crystallisation process, and facilitates ease of compliance with data integrity regulations.
ESSENTIAL PLATFORM MODULES
Real-time process control
SmartCrys comprises a suite of in-line process analysers to measure the physical and chemical quality attributes of the crystals. Manufacturing Intelligence interprets these measurements and decides whether process adjustments are required to achieve the optimum final product quality standards. Process Automation enables the automatic adjustment of the process to take place, while powerful Data Analytics Tools provide visibility of all process data in real-time and retrospectively.
WHAT DIFFERENCE WILL SMARTCRYS MAKE?
Advanced Process Control & Monitoring
To address key industry challenges, we are developing an innovative cloud-based, manufacturing intelligence called SmartCrys. This vertically integrated, advanced control platform is developed for crystallisation unit operations. PAT Analysers and advanced data analytics provide powerful insights into the physical and chemical properties of the crystals, while friendly automation enables real-time process control.
FASTER TIME-TO-MARKET
Alleviating drug shortages
SmartCrys will greatly enhance process understanding and control of the crystallization process, through-out the entire API and drug development life-cycle, enabling faster time-to-market for new drug products. PAT monitoring of the Critical Quality Attributes of the crystals, combined with real-time process control, will ensure consistent high-quality end product, reducing the risk of batch failures, while saving valuable resources.
ENSURES CONSISTENT PRODUCT QUALITY
Advanced dynamic process control
SmartCrys is an integrated solution comprising the Crystallization Vessel Suite, PAT Analysers, Data Analytics, Manufacturing Intelligence, a Process Automation module and Cloud Storage. SmartCrys delivers real-time control of the crystallisation process. Key parameters are adjusted in response to process deviations to compensate for variability in process performance. This ensures the process stays on the ideal path and that final product quality specifications are consistently met.
DATA INTEGRITY AND ANALYSIS
Big data tools
SmartCrys will assist manufacturers in meeting data integrity expectations set out by the Regulators. A vast quantity of data is generated throughout the development and manufacturing life-cycle of a drug product. SmartCrys ensures complete traceability of this data through efficient management and secure cloud archiving. The extendable, cloud-based infrastructure also supports big data analytics tools, enabling powerful data insights as well as access to historical process data.
