The clinical research company I work for carries out cell therapy in that T-cells are taken from a patient’s blood, which are then amplified via additives (viral vectors), and then expanded/proliferated until they reach the specified quantity stated in the batch record. The verification step therefore requires one sample to be taken for each day that the cells are being processed to ensure that the product remains viable. This requires performing analytical protocols on the samples by our QC department in order to ascertain that the cells are indeed growing and receiving the proper amount of additives. This is then carried out through tests such as flow cytometry, cell counting, and sterility testing to determine if the product is safe to infuse into the patient. If the product is not sterile, then it must be discarded. If the product lacks additives, then additives will be added, however a deviation will occur since it was clearly not done properly the first time. The same goes for measuring the cell counts of the product in that if the cell viability is too low, the process will have to be extended, but only after a deviation report (DR) is initiated. The reason for this is because the patients waiting for the infusions are afflicted with conditions (such as cancer, HIV, hepatitis, etc) that limit the amount of time that they can endure their sickness before requiring treatment. Therefore, if treatment is delayed for any reason, it must be accompanied by a lengthy amount of paperwork to justify the delay.

The Bonezone article posted this week on design verification and validation specifies the importance of labeling products throughout the verification process so that their specs can be easily compared to the ideal values. Are there any other techniques that can enhance the verification process? If a blood-infusion product is perfectly viable and 100% effective, but its batch record is missing a signature from a technician who is no longer employed at the company, should the product still be infused into the patient? What if the product was mislabeled but the manufacturer was aware of the mislabeling and insisted that the product still matched the desired specs? Assume that the patient only has days to live and is depending on the transfusion.