Adoptive immunotherapy, chimeric antigen receptor (CAR) T cell therapy involves an infusion of the patient’s own T cells that have been genetically engineered. Reprograming the T cells, and injecting the CAR T cells back into the patient encourages a positive immune response to fight the cancer cells and increase overall T cell survival as well as proliferation. Each CAR T cell therapy created is unique and specific to the patient, decreasing the potential risk for adverse impacts to the patient’s health. The patient’s extracted T cells are manually modified outside of their body to create healthy CAR T cells which are then formulated into a therapeutic dose for infusion back into the patient. The manufacturers of each CAR T product are responsible for producing a safe and appropriate dose for each patient. The re-infusion is a one-time infusion with high risk and a long recovery of 2-3 months.
Current good manufacturing practices (cGMP) are a good starting point for how a drug should be manufactured, tested, and delivered to the patient. The guidances, laws, and regulations included in cGMP provide the framework that organizations around the world use to ensure high product quality and confi rm they are safe and eff ective. Cell and gene therapy products, along with their patient populations, present unique challenges to immunotherapy manufacturers that require innovative solutions. Along with product quality and safety, production speed, from raw material to delivery, is a critical aspect due to product shelf-life and diminished health of the patient. These lifesaving targeted therapeutics need safe, effective, rapid release.