Potency analysis of cellular therapies: the emerging role of molecular assays

Potency testing is an important part of the evaluation of cellular therapy products. Potency assays are quantitative measures of a product-specific biological activity that is linked to a relevant biological property and, ideally, a product's in vivo mechanism of action. Both in vivo and in vitro assays can be used for potency testing. Since there is often a limited period of time between the completion of production and the release from the laboratory for administration to the patient, in vitro assays such are flow cytometry, ELISA, and cytotoxicity are typically used. Better potency 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 microRNA 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 microRNA expression profiling have the potential to be important tools for testing the potency of cellular therapies. Potency testing, the complexities associated with potency testing of cellular therapies, and the potential role of gene and microRNA expression microarrays in potency testing of cellular therapies is discussed

Sulfated Polysaccharide, Curdlan Sulfate, Efficiently Prevents Entry/Fusion and Restricts Antibody-Dependent Enhancement of Dengue Virus Infection In Vitro: A Possible Candidate for Clinical Application

10.1371/journal.pntd.0002188PLoS Neglected Tropical Diseases74

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Not AvailableThe genus Bacillus is one of the predominant bacterial genera found in soil, and several species of this genus have been reported from diverse ecological niches. Endowed with tremendous genetic and metabolic diversity, Bacillus spp. serve multiple ecological functions in soil ecosystem from nutrient cycling to conferring stress tolerance to plants. Members of the genus Bacillus are known to have multiple beneficial traits which help the plants directly or indirectly through acquisition of nutrients, overall improvement in growth by production of phytohormones, protection from pathogens and other abiotic stressors. This functionally versatile genus is one of the most commercially exploited bacteria in the agro-biotechnology industry. Still its potential has not been realized sufficiently and requires an emphasis towards translating the relevant technologies from laboratory to land for the benefit of mankind.Not Availabl