As the interest in the therapeutic value of iPSCs accelerates, so does the need to establish the regulatory framework and best practice in this area. There is a widely accepted regulatory expectation to use single cell cloning. By starting from a defined source cell variability, drift and ultimately product quality is best managed. For iPSCs, it is logical to explore methods to manage quality and overcome existing process hurdles by developing robust seeding and evidence of clonality methodologies. Limiting dilution, with a theoretical 30% seeding efficiency at 0.5 cells / well concentration has routinely been replaced in commercial laboratories by single cell seeding technologies. VIPS (Verified In-Situ Plate Seeding) is a well characterized high efficiency single cell seeding system, that offers the capture of evidence of clonality both immediately after dispensing into the plate well and post media fill, the so called ‘double lock’ of assurance. The system additionally provides daily whole well imaging to record further evidence of clonal outgrowth.
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