An average of five to 10 projects are awarded to EU companies by the FDA each year
The Research Center Pharmaceutical Engineering has been awarded FDA funding for two projects commencing in the 4th quarter of 2020. The projects will focus on utilising advanced technologies to improve production processes within pharma.
In partnership with companies including MSD and Pfizer, RCPE will use the funding to investigate the use of optical coherence tomography (OCT) for real-time monitoring and control of the drug tablet coating process.
It is a fantastic endorsement of our pioneering approach to solving drug manufacturing challenges
Integrating this technology with AI and machine learning approaches may enable researchers to effectively prevent errors in tablet coating before they occur. Its aimed to improve efficiency, minimise environmental impact and allow medicines to reach patients more rapidly.
In addition, RCPE will research the use of of digital simulation tools in drug product manufacturing and process development.
The project will focus on the development of a digital twin-based platform to virtually explore drug production control strategies. The platform will model products, processes and conditions to enable earlier evaluation, as well as optimisation and scale up, without the need for extensive lab-based experiments, RCPE says.
Adopting digital simulations is aimed to reduce not only drug development and manufacturing time, but also energy consumption and carbon footprint for next-generation pharmaceutical production.
Prof Johannes Khinast, RCPE CEO/Scientific Director, said: “We are incredibly proud to have been awarded two FDA contracts in a single year. It is a fantastic 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.”
Dr Thomas Klein, RCPE CEO/Business Director, commented: “We are delighted that the FDA has recognised the potential our projects offer for the industry and patients worldwide. The expertise and commitment of our multidisciplinary team have been instrumental in achieving our current success. We are excited to further build on our legacy of innovation as we work to transform pharma product development through the power of new technologies.”