ATMPs/C&GT - Data Science and R&D

ATMPs and/or C&GT when applied to the world of Research and Development and Data Science require specific approaches compared to its manufacturing counterpart. Due to the small processing volumes, a Scale Out approach is implemented over a Scale Up approach. Unlike Mab therapy that begins from a Working Cell Bank, ATMPs begin with the patient itself and the variability of the starting material is what characterizes the uniqueness behind personalized medicine. The R&D efforts for ATMPs are focused on a five-dimensional framework where the “five R’s” incorporates notions regarding the right target, the right tissue, the right safety, the right patients, and the right commercial potential. This session invites attendees to explore novel and collaborative methods to achieve a consistent robust process in developing a sustainable, scalable manufacturing platform. Improvements in smart manufacturing of ATMPs/C> supported by AI tools, digitalization and data science are key drivers to scientific, technical and operational progress. Coupled with non-invasive sensors for process monitoring along with dynamic contamination control strategies, the pathway from bench scale to market through smart manufacturing of ATMPs becomes a more tangible reality.