Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell- and tissue-based therapies, has announced a partnership with Pluristyx, Inc., an early stage, privately held biotechnology company specializing in induced Pluripotent Stem Cell (iPSC) products. 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.
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.”
About Theragent
Theragent is an advanced therapeutics Contract Development Manufacturing Organization in Arcadia, CA focused on accelerating scientifically complex cell- and tissue-based therapies for the treatment of cancer and other diseases with unmet medical needs. The company’s innovative cGMP facility offers comprehensive end-to-end manufacturing and in-house testing capabilities for clinical and commercial purposes. With a skilled scientific team and an emphasis on quality, safety, and next-gen manufacturing, Theragent strives to provide value-added solutions for clients with challenging pre-clinical and clinical trial projects.
Theragent. Patients are waiting. For more information, visit www.theragent.com.
About Pluristyx
Pluristyx, through its panCELLa platform, offers a portfolio of unique iPSC-based technologies, proprietary genetic engineering, and related tool-products and services to provide end-to-end client support throughout the products’ lifecycle. Pluristyx is fast becoming the leading provider of gene-edited iPSC and cell therapy solutions, accelerating customers’ path to clinic, and providing the best and fastest route to commercialization for cell-based therapeutic products. For more information on Pluristyx, visit www.pluristyx.com.