FDA Purchases XPS License for In-House Simulation Tool

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The Research Center Pharmaceutical Engineering (RCPE) and InSilicoTrials have announced that the United States Food and Drug Administration (FDA) has purchased a license for the XPS (eXtended Particle Simulations) software. XPS, a state-of-the-art Discrete Element Method (DEM) simulation software, is developed by RCPE and distributed by InSilicoTrials. It is known for its ability to predict granular processes in detail, improving efficiency and product quality in pharmaceutical operations.

The software utilizes advanced contact models to accurately describe the flow behavior of granular materials, making it valuable for process optimization. XPS can handle simulations with up to 100 million particles and provides rapid execution, contributing to its use on standard desktop machines.

The FDA’s decision to purchase the XPS license comes after a successful collaborative project with RCPE, focusing on powder flow and mixing in a continuous manufacturing line. XPS was used to predict Residence Time Distributions (RTDs) and validate them with experimental data collected at RCPE’s facility in Austria. The successful simulations showcased the software’s capabilities and led to the FDA’s adoption of XPS.

RCPE and InSilicoTrials see this collaboration as a significant milestone in the advancement of computational technologies in the pharmaceutical industry. The use of XPS can optimize R&D processes, reduce the need for physical experiments, and streamline pharmaceutical manufacturing.

The results of this collaboration have been shared at conferences, and future publications in peer-reviewed scientific journals are expected.

The Research Center Pharmaceutical Engineering (RCPE) and InSilicoTrials operate in the pharmaceutical industry, which is a sector involved in the discovery, development, production, and marketing of drugs for medical use. The industry plays a critical role in healthcare by providing medication to treat various diseases and improve patient outcomes.

According to market forecasts, the global pharmaceutical industry is expected to experience steady growth in the coming years. Factors such as an aging population, increased prevalence of chronic diseases, and advancements in technology contribute to the industry’s expansion. Additionally, the ongoing COVID-19 pandemic has highlighted the importance of the pharmaceutical sector in developing vaccines and therapeutics to combat the virus.

However, the industry also faces several challenges. One significant issue is the lengthy and costly process of drug development. Bringing a new drug to market typically involves extensive research, clinical trials, regulatory approvals, and manufacturing scale-up. This process can take many years and requires substantial financial investment.

Another challenge is ensuring product quality and safety. Regulatory agencies, such as the FDA, impose strict guidelines on pharmaceutical companies to ensure that their products meet stringent quality standards and are safe for patient use. Compliance with these regulations is crucial but can be complex and resource-intensive.

To address these challenges, the pharmaceutical industry has been embracing computational technologies and simulation software like XPS. These tools enable companies to optimize their R&D processes, accelerate drug development timelines, and reduce the reliance on physical experiments.

The partnership between RCPE and InSilicoTrials in developing and distributing XPS demonstrates the industry’s commitment to leveraging advanced technologies for process optimization. The software’s ability to predict granular processes in detail, such as powder flow and mixing, enhances efficiency and product quality in pharmaceutical operations.

The FDA’s decision to purchase the XPS license highlights the software’s effectiveness in regulatory applications. By using XPS to predict Residence Time Distributions (RTDs) and validating them with experimental data, the FDA can gain confidence in the reliability of the software for assessing manufacturing processes. This adoption further validates the value of computational technologies in the pharmaceutical industry.

As a result of this collaboration, the pharmaceutical industry can expect to see improved productivity, cost savings, and faster time to market for new drugs. The use of XPS can reduce the reliance on physical experiments, saving resources and expediting decision-making.

The successful simulations conducted with XPS have already been shared at conferences, demonstrating the industry’s interest in the technology. Future publications in peer-reviewed scientific journals are expected, which will contribute to the growing body of knowledge in computational technologies and their applications in pharmaceutical engineering.

For more information about the Research Center Pharmaceutical Engineering (RCPE) and InSilicoTrials, please visit their respective websites:

Research Center Pharmaceutical Engineering (RCPE)
InSilicoTrials