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Accelerating Clinical Timelines of Induced Pluripotent Stem Cells (iPSCs) with Pluristyx

Resilience and Pluristyx have entered a strategic collaboration to accelerate and simplify the transition of promising iPSC-derived therapies from the bench to the clinic.

The versatility of iPSCs has sparked enthusiasm within the therapeutic development industry, as these cells offer a potential solution to various existing gaps in cell therapy and in medicine in general. One of the most significant hurdles is that there are very few if any, organizations that offer end-to-end solutions that span GMP cell line acquisition and development all the way to clinical and commercial manufacturing at scale for iPSCs. More specifically, technical challenges such as reprogramming efficiency, genomic integrity, stability, scale-up of manufacturing, and clinical implementation must be overcome to fully realize their potential. Through this collaboration, therapeutic developers will benefit from Pluristyx’s capabilities as a leading provider of off-the-shelf and customized iPSCs for research and cGMP clinical use and Resilience’s platforms, knowledge, and capacity to conduct Cell Therapy Process and Analytical development, as well as scaling and manufacturing clinical and commercial Cell Therapies. The two companies will jointly work with customers to generate clinical-grade iPSC starting materials via the panCELLa Platform that can be transferred to Resilience for scale-up and manufacturing.

“It can be very challenging for early-stage groups developing next-generation cell-based therapies to navigate the procurement, licensing, and processing of the critical cellular raw materials required to test, manufacture, and get regulatory approval of their drug product. By partnering with Resilience, our customers can now access best-in-class iPSC starting materials that can be easily transferred to Resilience for clinical manufacturing, dramatically decreasing the time, complexity, and risk associated with cell therapy product development,” states Benjamin Fryer, Ph.D., Chief Executive Officer, and co-founder at Pluristyx.

"The iPSC clinical and pre-clinical pipelines are very promising and growing. However, the path to the clinic is extraordinarily complex and commercialization is extremely difficult. Through this partnership, we will offer a holistic, faster, more robust, less expensive, and risk-mitigated iPSC-centric path to the clinic and beyond. We will leverage Pluristyx’s capabilities as a pioneer in iPSC cells, and Resilience’s expansive Cell Therapy platforms, knowledge, and capacity, to ensure a seamless journey throughout the product lifecycle." said Eytan Abraham, VP & Business Head of Emerging Modalities at Resilience.

Together, the companies will provide their expertise to address critical challenges throughout the therapeutic development process, aimed at decreasing the time and complexity associated with iPSC-based cell therapy product development and manufacturing. By linking Pluristyx’s solutions with Resilience’s manufacturing science and technologies, we have the opportunity to enhance and accelerate iPSC-based therapies to improve the lives of patients around the world.

Want to learn more about the impact partnerships have in cell therapy commercialization success? Read here.