Development of an on-demand sensor and monitoring technology based on switchable nanobodies for cell therapy bioprocessing

Cell therapies, which use human cells to restore, maintain, or improve the functioning of human tissues or organs, hold enormous potential for the treatment of a wide range of diseases and conditions, including a variety of cancers. While cell therapies have the potential to improve healthcare for millions of patients worldwide, manufacturing remains a major hurdle for clinical translation.

Today's cell therapies manufacturing processes, which include the use of patient's own cells or donor cells to manufacture the therapeutic product, involve manual, labour-intensive and open processes that require highly-skilled personnel. This in turn leads to high process variability, risk of contamination and high manufacturing costs, all of which are major obstacles for cell therapies to realise their full potential and bring about widespread access to the global patient population.

New technologies are urgently needed to develop reliable and robust manufacturing processes that ensure quality and consistency of cell therapy products at an economically viable cost.

This project will develop an on-demand sensor and monitoring technology that will enable, for the first time, real-time, non-disruptive measurement of key biochemicals in cell culture media. These unprecedented capabilities will be enabled by an innovative microfluidic sensing platform comprising smart, switchable electrode-tethered nanobodies. In contrast with conventional offline analysis, the acquisition of real-time process data will allow immediate response to process variations, thus providing a fine level of process control.

This is essential for the consistent production of high-quality therapeutic cells in high yields, independently of the patient's or donor's cells. It will provide an exceptional opportunity to implement fully automated, robust cell therapy culture processes and bring down production costs, ultimately delivering cost-effective and impactful therapeutics to patients in need.