Patient-specific cell therapies (PSCTs) are still very new, and all parties involved in the manufacture and sale of these innovative treatments are getting their heads wrapped around how the process will work. To get to the reality of large scale PSCTs, an evolution will need to occur.
In this article from PCT (a Caladrius Company), the authors examine how the industry can move from our current state, to the future of manufacturing these challenging therapeutics.
The manufacture of PSCTs is a whole new animal, with familiar parts and pieces, but unarguably unique trouble spots. An example the authors provide is that failure of a patient-specific cell therapy lot not only incurs unreimbursable cost for the manufacturer, but it fails to treat a patient who was waiting for cells. It can get even more serious if the product is delivered to the wrong patient.
Due to the many challenges, cell therapy developers must invest in robust manufacturing processes that make products of high quality at a reasonable cost of goods. The processes need to be scalable and sustainable throughout the commercial life of each product. So how are cell therapy companies going to do this? What will it take to see large-scale personalized medicine? Read more in this article from BioProcess International magazine to find out.