On May 7, 2024 Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell- and tissue-based therapies, reported a partnership with Pluristyx, Inc., an early stage, privately held biotechnology company specializing in induced Pluripotent Stem Cell (iPSC) products (Press release, Theragent, MAY 7, 2024, https://theragent.com/theragent-and-pluristyx-enter-partnership-to-streamline-and-advance-ipsc-derived-therapy-development/ [SID1234642800]). Combined, this partnership will allow the companies to provide a seamless, end-to-end pathway to therapeutics developers from iPSC derivation to commercial production of iPSC-derived drug products.
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Under the terms of the collaboration, Pluristyx’s iPSC platform, including licenses for iPSC derivation, consent for use, and novel mechanisms such as the FailSafe functional suicide switch and iACT Stealth Cells immune evasion technology, will be utilized for early-stage programs and then synchronously transferred to Theragent for GMP processing including scale-up and clinical- to commercial-scale production at their state-of-the-art manufacturing facility in Arcadia, CA.
"Pluristyx is eager to grow our relationship with Theragent to create a synchronized platform that combines our clinical-grade iPSC lines and their CGMP manufacturing capabilities," said Dr. Benjamin Fryer, CEO and Co-founder of Pluristyx. "Together, we’re able to create a streamlined and transparent path from the bench to commercialization for the next-generation of iPSC-derived treatments."
"iPSC’s show untapped therapeutic potential, making it natural to enter a preferred partnership with an iPSC technical authority like Pluristyx," said Dr. Yu Yen, MD, PhD, and CEO of Theragent. "The tie-up leverages our stem cell expertise and our modern Pharma 4.0-driven manufacturing facility, resulting in ‘right first time, on time’ tech transfer and production – saving clients time and money while de-risking their clinical program."