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Two FDA-funded projects at RCPE will look at real-time monitoring and control of drug tablet coating and developing a digital twin for drug production control.
The Research Center Pharmaceutical Engineering (RCPE) in Graz, Austria has been awarded FDA funding for two projects, set to begin in the fourth quarter of 2020, that will focus on using advanced technologies to improve pharmaceutical production processes, RCPE announced in an Oct. 29, 2020 press release. RCPE noted that FDA typically only awards five to 10 projects a year to European organizations, which demonstrates that these projects have the potential for high impact within the global pharma industry.
In the first project, RCPE will partner with global pharma companies, including MSD (known as Merck in the US and Canada) and Pfizer, to investigate the use of optical coherence tomography (OCT) for real-time monitoring and control of the drug tablet coating process. Researchers will seek to integrate OCT with artificial intelligence (AI), such as machine learning approaches, to prevent errors in tablet coating before they occur.
In the second project, RCPE will partner with MSD, Pfizer, and other collaborators to continue previous work with digital simulation tools for drug product manufacturing and process development. A digital twin-based platform will model products, processes, and conditions, using these simulations for evaluation, optimization, and scale-up. Replacing extensive lab-based experiments is expected to reduce drug development and manufacturing time and reduce energy consumption and carbon footprint for next-generation pharmaceutical production.
Professor Johannes Khinast, RCPE CEO and scientific director, said in the press release that the awards are an endorsement “of our pioneering approach to solving drug manufacturing challenges. Having achieved this important milestone, we look forward to working with our partners to improve their manufacturing technology, ultimately benefitting patients around the globe.”