In a groundbreaking development for the pharmaceutical and fine chemical industries, a high-tech startup named Crystallization Systems Technology Inc. (CrySyst) has emerged, aiming to redefine how companies approach crystallization processes. Co-founded by Zoltán Nagy, an esteemed professor from Purdue University’s College of Engineering, and Botond Szilágyi, previously a postdoctoral research associate at Purdue, CrySyst is poised to tackle pressing challenges faced by industry professionals in crystallization monitoring, modeling, and control. The inception of this innovative company reflects years of rigorous research and collaboration with leading pharmaceutical corporations, underscoring the critical need for solutions that optimize crystallization processes further.
CrySyst’s approach is based on the quality-by-control (QbC) framework, which incorporates insights and methodologies derived from extensive academic research, prominently featured in reputable journals such as Crystal Growth & Design and Industrial & Engineering Chemistry Research. This framework not only facilitates the monitoring and modeling of crystallization but also emphasizes effective control mechanisms that can significantly enhance process efficiency. In a domain where precision is paramount, the QbC framework serves as a comprehensive guide, ensuring that all critical parameters are considered throughout the drug development process.
An essential aspect of the CrySyst offering lies in its two flagship software solutions, CrySiV and CryMoCo. The former is an interactive, user-friendly simulator based on population balance modeling, specifically designed for the digital design of crystallization processes. CrySiV excels in kinetic parameter regression, enabling users to simulate and visualize results in real-time, which is invaluable when monitoring dynamic chemical reactions. In addition, this simulator includes optimization features for both crystallization processes and integrated crystallization-wet milling techniques, utilizing advanced numerical methods for modeling and optimization.
Conversely, CryMoCo is an independent platform for monitoring and controlling crystallization processes. Its design is particularly noteworthy because it adheres to industry-standard communication protocols, making it compatible with various process analytical technologies and state-of-the-art control methods. This software allows for the rapid and direct design of robust crystallization processes, thus minimizing downtime and enhancing productivity for clients in the pharmaceutical sector. Notably, CryMoCo emphasizes a streamlined process that significantly reduces time and material usage while enhancing the scalability and reliability of processes.
A critical hurdle that Chemical Engineering and pharmaceutical companies face is the effective selection of experiments for model-based process development. Companies often grapple with uncertainty about which experiments yield the most relevant data and how to configure models to obtain reliable parameters. By directly addressing these challenges, CrySyst provides guided experiment selection and a semiautomated framework for model development. This structured methodology leads to high-confidence solutions, ensuring that every step of the modeling process is grounded in scientific rigor and empirical data.
In talking about the industry’s growing challenges, Nagy has highlighted the pressures pharmaceutical and fine chemical companies face, including constrained material availability, limited experimental resources, and the lengthy timelines required for traditional optimization through experimental methods alone. In response, the tools developed by CrySyst are tailored to meet these demands, representing a significant leap forward in the field of crystallization science and its applications. Adopting model-based digital design offers a pathway to overcome these hurdles, with robust tools designed for practical application in industrial settings.
The genesis of CrySyst was significantly bolstered by funding from the Enabling Technologies Consortium, which included contributions from over ten major pharmaceutical companies. The collaborative nature of this effort fostered a rich dialogue between the company founders and crystallization scientists from these industry leaders, allowing for the development of practical tools that align with industry needs. Feedback from these extensive interactions ensured that CrySyst’s solutions were rooted in real-world applications, making them highly relevant for current challenges faced by the pharmaceutical sector.
Moreover, CrySyst is not merely offering software solutions; it emphasizes providing comprehensive consultancy and training services. This multifaceted approach stresses the importance of user education and support, ensuring that clients can effectively leverage the capabilities of CrySiV and CryMoCo. As pharmaceutical companies transition towards model-based and model-free direct design strategies, having knowledgeable partners who can facilitate this shift is vital.
In light of the increasing complexity of developing new pharmaceutical drugs and fine chemicals, the integration of innovative solutions like those offered by CrySyst is becoming indispensable. Their commitment to providing high-quality control and monitoring tools is set to enhance not only the efficiency of individual processes but also the greater goal of expediting drug development timelines. The capacity to quickly adapt and optimize processes will transform how companies maneuver in an increasingly competitive market.
As CrySyst continues to innovate and expand its offerings, its founding team remains dedicated to the pursuit of cutting-edge developments that could further revolutionize crystallization processes. Their vision aligns with the industry’s need for sustainability, efficiency, and rapid scalability, ultimately leading to a more proactive approach in pharmaceuticals and fine chemical production. By harnessing the power of advanced modeling and monitoring technologies in crystallization, CrySyst is shaping the future of process development.
The evolution of crystallization technologies within the CrySyst framework exemplifies a broader trend towards integrating modern computational technologies in traditional chemical engineering practices. As the industry progresses, the emphasis will likely shift to incorporating digital solutions that support enhanced decision-making processes, thereby laying the groundwork for continuous improvement. This forward-thinking mindset places CrySyst at the forefront of transforming the crystallization landscape, establishing new benchmarks for efficiency and effectiveness in the development of pharmaceutical processes.
In summary, the launch of CrySyst represents a significant milestone in crystallization R&D within the pharmaceutical and fine chemical sectors. With its cutting-edge software tools, industry-specific insights, and unwavering commitment to educational support, the company stands to redefine what is possible in process development. As technologies evolve and the need for more sophisticated methodologies increases, CrySyst is well-positioned to lead the way in creating innovative crystallization solutions that meet the demands of an ever-changing industry.
Subject of Research: Crystallization Process Development
Article Title: CrySyst: Revolutionizing Crystallization in Pharma
News Publication Date: October, 2023
Web References: CrySyst, Purdue University
References: Crystal Growth & Design, Industrial & Engineering Chemistry Research
Image Credits: Purdue University photo/Vincent Walter
