With autologous ex-vivo gene therapies, every batch of drug product is custom manufactured and dosed to each individual patient. Treating 100 patients per day will require 100 drug batches to be manufactured, tested and released per day.
As the patient’s condition can deteriorate rapidly, drug batches must be tested and released for use quickly, ideally within one week of manufacture.
Current analytical methods rely on laboratory facilities and are labor intensive requiring significant analyst time.
Flow cytometry requires highly skilled labor to measure the populations of cell immunophenotypes, requiring sample preparation, mixing of antibodies, setting up instrument, running of the instrument and interpretation of the data.
With common indications, the strategy is to automate the manufacturing so that it is brought close to bedside. Ideally the analytics would be automated and also carried out at / close to bedside to provide rapid sample to result data.