Pluristyx, Inc. entered into an agreement with the Advanced Regenerative Manufacturing Institute BioFab USA to manufacture and commercialize Pluristyx’s clinical grade reprogrammed induced Pluripotent Stem Cells (iPSCs). The collaboration will make it possible to accelerate the scalable, consistent, and cost-effective manufacturing of stem cell derived products for patient administration.

The agreement provides ARMI BioFab USA, its affiliates, and Members streamlined access to high-quality clinical grade iPSCs for cell and gene therapy manufacturing. Pluristyx’s iPSCs are derived from fully consented and regulatory appropriate donors procured under Good Tissue Practices (GTP). The iPSCs are available in two tiers: a research-grade version for evaluation prior to licensing and a full GMP (Good Manufacturing Practice) compliant version with license. ARMI BioFab USA members can also incorporate multiple proprietary panCELLa gene edits, including the FailSafe safety switch, iACT allogeneic cell cloaking technologies, and other custom genetic modifications to create a universal and scalable starting material for clinical development.

“We are thrilled to expand our relationship with ARMI | BioFab USA and provide our clinical grade iPSCs to advance the development of tomorrow’s stem cell derived therapies. As long time ARMI BioFab USA Members, we look forward to expanding our work to fulfill the organization’s mission of bringing revolutionary products to patients in need,” said Benjamin Fryer, CEO Pluristyx

“By working with Pluristyx to deliver clinical grade iPSCs, our members will have a reliable and stable source material, and this will help accelerate the path to commercialization. Alongside Pluristyx, ARMI BioFabUSA is proud to deliver this opportunity and accelerate the impact of our ecosystem,” said deputy director, Maureen Toohey.