WIA Cellular Therapy Standard Guide

A cell therapy product is not a molecule in a vial. It is a population of living cells that was, in many cases, inside the patient only two weeks earlier, and it will go on changing after it is infused. This chapter explains what that means for everyone who touches the product: the scientist who grows it, the QA reviewer who releases it, the nurse who hangs the bag and the engineer who writes the software that tracks it. It then maps the WIA-BIO-005 specification onto that journey.

Most medicines fall into two familiar groups. Small-molecule drugs are chemically defined: every tablet in a lot holds the same compound, and purity can be proven by analytical chemistry. Biologics such as monoclonal antibodies are made by living cells, but the product itself is a protein that is purified away from those cells, characterised and then stored for months or years. A cell therapy product goes one step further: the cells are the active ingredient. They are harvested, sometimes genetically modified, grown, formulated and infused while still alive, and their therapeutic effect depends on what they do inside the patient afterwards: dividing, homing to tissue, killing target cells or secreting signalling molecules.