- Made Scientific and Pluristyx have entered a strategic partnership to integrate GMP induced pluripotent stem cell (iPSC) technologies into Made Scientific’s cell therapy CDMO services.
- The collaboration aims to provide cell and gene therapy developers with access to regulatory-ready iPSC lines, derivative cell types, and coordinated GMP manufacturing services.
Made Scientific has entered a strategic partnership with Pluristyx to integrate induced pluripotent stem cell (iPSC) technologies into its cell therapy contract development and manufacturing organization (CDMO) offering. The agreement is designed to provide global cell and gene therapy developers with access to GMP-ready iPSC lines and derivative cell types for research, clinical development, and commercial manufacturing.
Under the partnership, Pluristyx will serve as Made Scientific’s iPSC supply and development partner, providing research-use-only and GMP-grade iPSC lines as well as derivative cell types, including induced natural killer (iNK) cells and induced mesenchymal stem cells (iMSCs). The companies said the collaboration will support manufacturing activities conducted in accordance with FDA, EMA Annex I, and other global regulatory requirements.
The agreement combines Pluristyx’s regulatory-ready iPSC platform with Made Scientific’s GMP development and manufacturing infrastructure. According to the companies, the integrated approach is intended to reduce development timelines by providing donor consent documentation, characterization data, and regulatory materials upfront, allowing process development and GMP manufacturing activities to begin immediately.
The partnership also extends to customized cell line development programs. Made Scientific and Pluristyx will jointly support cell differentiation projects, including the generation of iNK, iMSC, and other lineage-specific cell types, as well as the manufacture of GMP master and working cell banks. The companies stated that aligning development and manufacturing activities under a coordinated workflow is intended to reduce operational complexity and minimize handoff risks during product development.
“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. 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.”
Priya Baraniak, PhD, Chief Commercial and Development Officer of Pluristyx
