One of the biggest challenges faced by CAR-T Cell manufactures is the variability among apheresis product, which can negatively impact T Cell manufacturing success and therefore patient treatment. A solution is required to minimise this variability such that the CAR-T manufacturing process can be standardised in accordance with Good Manufacturing Practices (GMP). We show that our technology, LeukoStor™ T25, enhances the predictability of starting T Cell yield compared to freeze-thaw and no-gel controls (Fig 1a). LeukoStor™ 25⁰C maintains >90% T-Cell viability after 5 days’ storage (Fig 1b), providing a 2-fold improvement compared to unprotected material (no-gel control). In apheresis material, the expected T Cell proportion is 53.8±6.1% (1), which is maintained by LeukoStor™ after 5 days’ storage (Fig 1c). Assessment of viability and metabolic capability following overnight culture shows that cells also maintain post-rest function after storage in LeukoStor™ (Fig 1 d, e).
The benefits of LeukoStor™ T25 address one of the critical drivers of CAR-T manufacturing delay by demonstrating how this cell storage technology can provide consistent, high quality starting material, offering a step towards both standardization and a reduction in vein-to-vein time (V2V). The current 2–3-week V2V time, defined as the time that elapses between apheresis and product delivery at the hospital, can be problematic and impact patient eligibility given the rapid progression of the disease. Implementation of LeukoStor™ T25 may offer a reduction in V2V and in turn reduced cost, through optimising time-limiting quality control processes or even storing cells from early apheresis. For CAR-T developers, complex cold chain also remains a challenge, for the transport of apheresed and manufactured cells between manufacturing facilities and hospitals. LeukoStor™ offers the potential to mitigate the need for temperature-controlled transport, through successful cell storage at 25⁰C.
References
- Blood [Internet]. miltenyibiotec. [cited 2022 Sep 12]. Available from: https://www.miltenyibiotec.com/GB-en/resources/macs-handbook/human-cells-and-organs/human-cell-sources/blood-human.html
