The goal of these studies is to develop novel methods to assess the quality of cellular therapies. Traditional analytic assays including ELISA, flow cytometry, and ELISPOT have many limitations. Better assays are needed to assess the complex and multiple functions of cellular therapy products, some of which are not well understood. Gene expression profiling using microarray technology has been widely and effectively used to assess changes of cells in response to stimuli and to classify cancers. Preliminary studies have shown that the expression of noncoding micro RNA which play an important role in cellular development, differentiation, metabolism and signal transduction can distinguish different types of stem cells and leukocytes. Both gene and micro RNA expression profiling have the potential to be important tools for assessing cellular therapies. In addition, these assays could be used to identify biomarkers that correlate with the safety, purity, and potency of cellular therapies; validate that therapies prepared using different methods are equivalent; and assess changes in the cellular therapy manufacturing process. The development of these assays will lead to safer and more effective therapies for all patients being treated with cellular therapies.
- Develop novel molecular methods to access cellular therapies
- The cell therapy laboratory invests a considerable amount of resources in the development of new cellular therapies. While the development of most of these cellular therapies are initiated in the laboratory of clinical investigators, the Cell Processing Laboratory must scale up and validate these procedures. For many protocols this process involves considerable scientific, medical, regulatory and laboratory input from the Cell Processing Section.
- Identify and validate biomarkers for cell potency, purity, and viability
- Validate biomarker expression by the cellular therapies with their clinical effectiveness