ABSTRACT
Cell-replacement therapy has emerged during the past decade as a potential solution for many diseases. However, for this promise to be fulfilled, numerous process development challenges specific to these products need to be overcome. This editorial overview highlights some key observations derived from research on an allogeneic somatic cell therapy product for the treatment of Parkinson's disease.
Subject(s)
Cell- and Tissue-Based Therapy/methods , Cell- and Tissue-Based Therapy/trends , Animals , Cell Proliferation , Humans , Time Factors , Tissue and Organ HarvestingABSTRACT
A bioassay that measures the potency of the FGF-4 transgene carried by a replication incompetent adenovirus type 5, Ad5FGF-4, was developed on ARPE-19 cells. The assay is carried out in a microtiter plate format and measures cellular proliferation following infection of ARPE-19 cells with a serial dilution of Ad5FGF-4. Proliferation is measured as a percentage increase in absorbance reading in relation to a mock-infected control. Ad5LacZ and Ad5FGF-4 viruses treated similarly to the test sample are included as negative and positive controls, respectively. The increased absorbance reading resulting from infection with the virus correlates with FGF-4 production as determined by an FGF-4 enzyme-linked immunosorbent assay, an increase in de novo DNA synthesis as measured by BrdU incorporation, and an increase in the total cell number. The assay shows a dose-dependent response and is capable of evaluating the stability of Ad5FGF-4. A sample being tested is compared with a reference standard, and the relative potency value is obtained by a parallel line analysis of the dose-response curve of the test article in relation to the reference standard. Therefore, this procedure can be used as an in vitro efficacy-indicating assay, demonstrating that the FGF-4 transgene product carried by Ad5FGF-4 is biologically active.
