Enabling automated monitoring without contamination

The production of biopharmaceuticals and cellular therapies depend upon the cultivation and maintenance of living cells in a highly controlled environment.  Although these techniques differ in scale, a need exists in both cases to monitor and quantify chemical entities within bioreactor culture vessels so as to maintain system integrity and content viability.

The most publicized current opportunity in cell therapy is immunotherapy for blood cancers like leukaemia and lymphoma.  In some trials, remission rates have been remarkable (80-90%) but at present, it is only used with the most ill patients who have exhausted other treatment options. Improving process control will be required for these therapies to transition from last resort to standard of care. Improvements in process control require substantial advances in sensors and analytics. Without these improvements, cell therapy will be of limited value to society.

Cells for these therapies are grown within a sealed bioreactor. There are a range of analytical methods available to ascertain the environmental and cell biology status of the bioreactor.  However, the current methods necessitate the expensive manual steps of withdrawing material from the bioreactor for external analysis and thereby increase the risk of catastrophic losses due to potential microbial contamination.  These constraints limit sampling frequency and the success of the cell therapy production.

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