Developing new medicines is a time-consuming and expensive process and suffers from a high failure rate due, in part, to side-effects that cannot adequately be predicted in preclinical testing. Human safety risks are typically evaluated using data from animal models and in vitro assays of important tissue, cellular and biochemical functions. This approach has several limitations, for example, a lack of cross-species translation resulting from inter-species differences in biological pathways and pharmacokinetic properties. Indeed, there is a clear and unmet need for improved predictability and higher throughput assays of human toxicity to help assess the growing number of xenobiotics being produced within the pharmaceutical, chemical and related industries.
Within the drug development market today, the availability of human cells would overcome the limitations of cross-species predictions and make transformative change in toxicity testing cascades possible. Combined with newer technologies that quantify cell type-specific functions, human cell assays could be used to drive the structure–activity relationship and improve safety profiles. The strategy of using human cells with cell type-specific functional readouts could improve the predictive capabilities of in vitro assays and could also reduce reliance on animal studies, which in addition to ethical concerns, are low throughput, expensive and time consuming.
Accellta develops customized processes and provides modern technologies for the manufacturing of cells for drug discovery companies screening new drug candidates or performing functional or toxicology studies using human differentiated cells or organoids.