Publications by authors named "Stephanie Switalski"
Human induced pluripotent stem cells (iPSC) have demonstrated massive potentials for use in regenerative and personalized medicine due to their ability to expand in culture and differentiate into specialized cells with therapeutic benefits. However, in order to industrialize iPSC-derived therapies, it is necessary to address the existing challenges surrounding the analytics implemented in the manufacturing process to evaluate and monitor cell expansion, differentiation, and quality of the final products. Here, we review some of the key analytical methods used as part of identity, potency, or safety for in-process or final product release testing and highlighted the challenges and potential solutions for consideration in the Chemistry, Manufacturing and Controls (CMC) strategy for iPSC-based therapies.
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- * Current techniques, like flow cytometry, have limitations such as high sample input, low throughput, and standardization challenges, hindering proper characterization of cell therapy products.
- * The described assays utilize isolated genomic DNA to identify and quantify specific immune cell types through DNA methylation patterns, enabling high throughput and robust testing for T cells and potentially improving cell therapy processes.