SEATTLE, Wash., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Pluristyx, Inc. today announced the formation of the Organoid COMMONS (Consortium for Organoid Manufacturing, Measurement, Optimization, and Network for Standards), a public-private consortium created to accelerate the adoption of human-relevant organoid models.
Pluristyx will lead the initiative, bringing together ten industry partners to establish global standards and workflows for organoid development, manufacturing, and characterization that de-risk preclinical programs and drive regulatory acceptance of non-animal, iPSC-based test systems. Initial founding partners include Solesis, BioLamina, XCell Biosciences, Defined Bioscience, Teknova, Discovery Life Sciences, and several other industry leading cell and gene therapy tools providers.
The consortium's mission is a direct response to the FDA Modernization Act 2.0 and the FDA’s urgent mandate to replace traditional animal testing with predictive, human-relevant New Approach Methodologies (NAMs). With over 90% of drug candidates that pass animal tests failing in human trials, the Organoid COMMONS will establish the standardized, regulatory-accepted workflows, iPSC banks, and organoid libraries needed to de-risk therapeutic development.
"The landscape of preclinical drug discovery is at a critical inflection point, and the mandate to replace animal models is clear," said Dr. Priya Baraniak, Chief Commercial and Development Officer at Pluristyx. "Pluristyx is proud to lead this critical initiative. By bringing together the best-in-class technologies from our partners, we are moving beyond just talking about the problem; we are building the solution. The COMMONS will enable creating the standardized, human-relevant models that will define the next generation of drug discovery."
The consortium's strategy is to create a "three-pillar approach" that integrates the market-leading technologies of its members into reproducible workflows for organoids:
- Standardized Cellular Material: High-quality, well-characterized induced pluripotent stem cells (iPSCs), PluriForm™ Organoid Kits, and primary donor cells.
- Defined Microenvironment: Advanced 3D biomaterial scaffolds, transfection reagents, and recombinant laminin matrices.
- Scalable Manufacturing & Analytics: cGMP-grade media, reagents, cryopreservation solutions, and advanced tissue microenvironment platforms.
The Organoid COMMONS will operate as a pre-competitive alliance, allowing partners to collaborate on developing products to meet and set industry standards. The consortium was formally established in Philadelphia on November 20, 2025, where the Governing Board was appointed and initial proof-of-concept projects were defined. For more information on the COMMONS, contact Dr. Priya Baraniak.
About The Organoid COMMONS
The Organoid COMMONS is a collaborative consortium organized by Pluristyx to pioneer the future of drug discovery. It is designed to establish global standards for iPSC-derived organoids and build a comprehensive ecosystem that will revolutionize non-animal model research, accelerate therapeutic development, and bolster America’s global leadership in advanced biomanufacturing.
About Pluristyx
Pluristyx is the leading provider of advanced iPSC-based solutions for the cell and gene therapy industry, delivering a comprehensive platform designed to accelerate therapeutic development with unmatched speed, safety, and scalability. Leveraging proprietary mRNA bulk reprogramming and a polyclonal iPSC approach, Pluristyx produces genetically younger, more stable, and highly expandable cells. The company’s portfolio spans off-the-shelf, clinical-grade iPSC lines, custom gene editing and engineering, and innovative safety and immune-evasion technologies, including the FailSafe® safety switch, iACT™ immune cloaking system, and HLA-null capabilities. Beyond cell sourcing, Pluristyx supports the entire development continuum, from concept to organoid-based disease modeling, high-throughput drug screening, and GMP-scale manufacturing, empowering therapeutic developers to streamline workflows, reduce risk, and accelerate the path to clinic.
Media Contact:
Dr. Priya Baraniak
Chief Commercial and Development Officer
priya@pluristyx.com
