Next Gen Cell Therapies Need Next Gen Cell Counters

By Steve Wiltgen, PhD., Sr. Manager, Customer Success and Commercial Enablement, Ovizio

Cells that were once part of the process of making or testing pharmaceuticals are now treatments themselves in the next generation of drug development: cellular therapeutic products (CTPs). Traditional cell counting methods such as sampling, staining, and image acquisition, have always been used however they have proven either inefficient, subjective, time-consuming, or not customized to fit the needs of CTPs.

Viable cell counting helps determine dosing; therefore, it comprises a critical quality attribute of CTPs. When cell counts are wrong, dosing inaccuracies may follow, which could lead to poor efficacy and compromised safety. Examples include inadequate duration of action due to insufficient cell viability or even organ failure or death caused by mutagenesis or a severe inflammatory immune response from excessive dosing. Bioprocessing development of monoclonal and recombinant antibodies also requires accuracy in cell viability counts. Correctly balancing feeding times and cell growth leads to superior product quantity and quality.

We take a closer look at the inadequacies of current cell counting methods and explore a newer technology that is now available that solves the problems of conventional cell counting methods and may better help with manufacturing and quality control of CTPs.