Consistent Cell Count & Viability for Development & Manufacturing
Cell-based immunotherapy covers a broad range of treatments where immune cells are injected into patients. These therapies are more commonly known to treat different types of cancer and autoimmune diseases. Chimeric antigen receptor T cells (CAR-T), for example, are currently being evaluated in clinical trials for a variety of indications.
CAR-NK cells are becoming a likely alternative to CAR-T therapies due to their lack of Graft-versus Host Disease (GvHD) implications. CAR–NK cells have the potential to become a standard allogeneic treatment for cancer indications. Dendritic vaccines are also under investigation for their ability to engage the body’s own T cells to fight against cancer.
What’s the Challenge?
It is critical to consider the production process when designing a cell-based immunotherapy, as it is the cells themselves that are the medicinal product or drug, also called the Cell Therapy Product (CTP)1. The cells might have to undergo a differentiation process before they are injected into patients and it is crucial to count the cells both before and after differentiation to manufacture a standardized and consistent CPT. Besides cell number, viability is important, as the cell dose depends on how many cells are viable.
The NucleoCounter® NC-202™ automated cell counter (and previous generation NucleoCounter® NC-200™), has been adopted as the gold standard by companies leading the cell-based immunotherapy field. Several of the FDA-approved CAR-T therapies utilize the NucleoCounter® in their manufacturing and quality control, and often in the upstream process of research and product development. The instrument’s ability to provide robust and precise cell counting and viability data makes the NucleoCounter® first choice.
With the NucleoCounter® instruments, it is easy to monitor the whole process from leukapheresis through purification, expansion, and finally when formulating CAR-T cells. Using the same instrument ensures consistent, precise and reliable results.
Precision Comes From Our Via2-Cassette™ Technology
The NucleoCounter® NC-202™ delivers the highest level of precision amongst all counting methods, including other automated cell counters and manual counting. The secret to this precision is the Via2-Cassette™ which minimizes user error by avoiding the need for sample/reagent mixing and pipetting.
In addition, every cassette is individually volume-calibrated to ensure accurate calculation of cell concentration. To ensure you get the most precise count possible, each instrument is calibrated to a master instrument and therefore does not need to be calibrated again. This ensures that technology transfer situations are easier, and less validation is needed.
- P Bedford, J Jy, L Collins et al.: Considering Cell Therapy Product “Good Manufacturing Practice” Status. Front Med. 2018; 5: 118.