Strategic partnership integrates Pluristyx's clinical-grade iPSC platform into Made Scientific's CDMO services, giving developers a single-source path from cell line to commercial supply.
PRINCETON, N.J. and SEATTLE, June 4, 2026 /PRNewswire/ -- Made Scientific, Inc., a leading U.S.-based clinical- and commercial-stage cell therapy contract development and manufacturing organization (CDMO), and Pluristyx, a leading provider of RUO and GMP induced pluripotent stem cell (iPSC) platform technologies, today announced a strategic partnership to integrate Pluristyx Technology including GMP iPSC lines and derivative cell types, including induced natural killer (iNK) cells and induced mesenchymal stem cells (iMSCs), into Made Scientific's end-to-end CDMO offering for global cell and gene therapy innovators.
Under the agreement, Pluristyx will serve as Made Scientific's iPSC and iPSC-derivative supply and development partner, providing client access to RUO and GMP-ready iPSC lines and derivative cell types for use across R&D, clinical, and commercial manufacturing under FDA, EMA Annex I, and global regulatory compliance.
"The demand for iPSC-derived cell therapies is accelerating, and the availability and quality of iPSC starting material is one of the most consequential variables in timely and cost-effective manufacturing outcomes," said Syed T. Husain, Chairman & CEO of Made Scientific. "Pluristyx brings a unique and proprietary iPSC platform to Made Scientific —with built-in safety, immune evasion, and regulatory-compliant source material — that directly addresses what our clients need to move faster and with greater confidence. This partnership strengthens our position as a full-service development and manufacturing partner for the next generation of iPSC therapies."
By pairing Pluristyx's pre-qualified, regulatory-ready iPSC lines with Made Scientific's GMP development and manufacturing infrastructure, and enabling sublicensing of Pluristyx technology by Made Scientific, the partnership delivers a true plug-and-play platform for iPSC-derived therapy developers. Sponsors avoid additional months of timeline and the significant program cost, typically driven by sourcing and re-characterizing starting material, negotiating separate license agreements, qualifying multiple vendors, and reconciling overlapping regulatory packages across suppliers.
Pluristyx's iPSC lines arrive at Made Scientific with the donor consent, characterization, and regulatory documentation already in place meeting 21 CFR 1271 and 21 CFR 210/211 compliance allowing process development and GMP manufacturing to begin on day one. The result is a compressed path to IND, fewer redundant quality and analytical workstreams, and a meaningfully lower total cost of getting an iPSC program from concept to clinic.
The partnership extends beyond starting material supply into a coordinated service model for sponsors who plan to further engineer, differentiate, or otherwise customize an iPSC bank. Made Scientific and Pluristyx will jointly support cell line differentiation programs, including the generation of iNK, iMSC, and other lineage-specific derivatives — alongside custom GMP master and working cell bank manufacturing of engineered or differentiated material. By aligning Pluristyx's iPSC reprogramming, engineering, and differentiation technology platforms and expertise with Made Scientific's GMP banking and downstream manufacturing capabilities under a single coordinated workflow, the companies give developers one point of accountability, removing the handoff risk and timeline drag that typically accompany bespoke iPSC programs.
"Made Scientific's development and manufacturing expertise and infrastructure make them an ideal partner to bring the full potential of our iPSC platform to therapeutic developers globally," said Priya Baraniak, PhD, Chief Commercial and Development Officer of Pluristyx. "Together, we're giving sponsors a coordinated path from clinical-grade starting material through GMP manufacturing — one that's built for speed, regulatory compliance, and scalability across the cell types that matter most in next-generation autologous and allogeneic programs."
About Made Scientific
Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical- and commercial-supply. Headquartered in Princeton, New Jersey, Made Scientific combines the agility of a specialist CDMO with the deep technical expertise to deliver reliable and scalable solutions, supported by their long-term strategic backer, GC Corporation, a global leader in the pharmaceutical and biotechnology sectors. For more information, visit www.madescientific.com.
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. For more information, visit www.pluristyx.com.
Media Contacts
Made Scientific [email protected] | LinkedIn: @MadeScientific
Pluristyx [email protected] | LinkedIn: @Pluristyx
SOURCE Made Scientific, Inc.
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