GSK is seeking rapid, point of care analytical tests for gene therapy products that can go from sample to result within 2 hours
Tests should work with human cells at a concentration of 1x106 – 1x108 cells per mL in growth media. They should measure the gene copy numbers per cell in the sample.
Lab tests are welcome. GSK would be especially interested in analytical techniques that could be carried out at or close to the patient’s bedside.
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.
To measure gene copy numbers per cell currently requires an analyst to carry out DNA purification, setting up of the PCR reagents, 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.
Reduce the testing time, ideally from sample to result in <2hrs
Point of care tests (diagnostics)
Microfluidic disposable cartridge technology
Automating the current methods