Engineering a Medical Revolution
Cell Therapies are the emerging Third Pillar of Therapeutics alongside small molecules and biologics. The transition from Molecular to Cellular Therapies is so profoundly game-changing that it bears comparison to another medical revolution: the development of penicillin.
Professor Alexander Fleming (1928)
(I’m not surprised there was mould everywhere in this lab)
The accolades for penicillin went to Fleming, Florey and Chain for their discoveries and purifications, but the story of how penicillin became so widely available lies in Process Engineering. In this fascinating article on Chemical Engineers Who Changed The World, Claudia Flavell-While describes how penicillin manufacturing was scaled up from barely enough material to run clinical trials pre-WWII to enough for every Allied soldier to carry a dose in their pack on D-Day.
Previously, penicillium moulds could only be grown on the surface of liquids. This meant their culture was constrained to two-dimensions. By adapting deep-tank fermentation technology first developed for citric acid production, Pfizer engineers Jasper Kane and John McKeen were able to expand penicillium culture into three dimensions. This unlocked the production volume needed to take a niche therapeutic opportunity through to a world-changing medical breakthrough.
Right now, Cell Therapies are on a similar journey. Clinical trials show enormous promise but we still face considerable Manufacturing challenges. Even now, a similar transition from 2D flask-based culture to 3D bioreactor remains part of the puzzle, but still greater challenge lies in enabling advanced process control.
Next-generation Cell Analytics for Advanced Bioprocess Control
Keeping a Cell Therapy expansion process on track requires maintenance of cell identity and health throughout manufacturing as these are critical determinants of clinical utility. Current cell analytics to monitor health and identity can take longer than the manufacturing process itself to deliver results. We cannot build advanced bioprocess controllers for smart factories and automated near-patient manufacturing upon such slow, cumbersome cell analytics.
CELLIMAGE will develop simple, fast cell analytics based upon label-free cell imaging interpreted by AI. This is a true enabling technology. With CELLIMAGE technology we will be able to monitor cells during expansion and drive pre-administration release tests in clinics.
Kane and McKeen are the lost heroes of the story of penicillin. Such is the lot of engineers. Our ambition is to leave a similar mark on Cell Therapies so that they too become routinely available to patients across the World.