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Hannah Cobb, Silvia Aparicio-Domingo, M. Valeria Canto-Soler; Transitioning into GMP-Compliance: Alternative Methods for Producing Retinal Organoids for Transplantation. Trans. Vis. Sci. Tech. 2021;10(10):9. https://doi.org/10.1167/tvst.10.10.9.
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Three-dimensional retinal organoids derived from human induced pluripotent stem cells (hiPSCs) are gaining much attention as a possible source for cell transplantation to treat retinal degenerative conditions. However, the protocol for producing retinal organoids is time and labor intensive, involving a sequence of precise steps, and thus has yet to be successfully translated into a Good Manufacturing Practice (GMP)-compliant procedure. This review seeks to define the progress that has already been made in the pursuit of designing a GMP-compliant, streamlined, and automated protocol for retinal organoid production for optimal clinical success. The reviewed literature compares various approaches for cell culture automation, appropriate xeno-free conditions, and cell sources for iPSC line generation; yet, there are still important gaps for these three key considerations that remain to be addressed. Thus, the authors also discuss further potential strategies to successfully achieve GMP-compliant production of retinal organoids for eventual safe and efficient use in clinical trials.
Designing a GMP-compliant protocol for three-dimensional retinal organoid production is of urgent need in order to bring transplantation of hiPSC-derived retinal tissue and derived cells to clinical trials – and ultimately patient treatment – for retinal degenerative diseases.
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