New Jersey-based Made Scientific, Inc., a cell therapy contract development and manufacturing organization backed by South Korea's GC Corporation, has launched an integrated iPSC development and manufacturing partnership with Seattle-based Pluristyx, Inc., embedding Pluristyx's clinical-grade iPSC platform directly into Made Scientific's CDMO services. The arrangement is designed to give cell therapy developers a single-source path from iPSC line selection and banking through GMP manufacturing and commercial supply. Neither company is publicly listed; Pluristyx is backed by BioLife Solutions (Nasdaq: BLFS) and BroadOak Capital Partners. Financial terms were not disclosed.
The partnership integrates Pluristyx's PluriBank iPSC lines — which carry an active US FDA Drug Master File — alongside its Ready-to-Differentiate (RTD) frozen cell bank format and two proprietary engineering overlays: iACT Stealth, described by the company as an immune evasion technology designed to reduce allogeneic rejection, and FailSafe, an inducible safety switch licensed from the University of Washington that enables selective elimination of transplanted cells if adverse events arise. Together, these components are described by Pluristyx as a stacked clinical-grade iPSC starting material platform intended to reduce regulatory and manufacturing friction for allogeneic cell therapy developers.
Pluristyx uses a footprint-free mRNA reprogramming method to generate its iPSC lines, avoiding genomic integration of foreign DNA — a regulatory concern associated with older viral vector-based reprogramming approaches. The RTD format allows iPSCs to be thawed and used immediately in differentiation workflows without additional expansion steps, addressing a known variability bottleneck in iPSC-based manufacturing processes.
Made Scientific operates from two US-based facilities and expanded its Princeton, New Jersey GMP site by 12,000 square feet in 2025, adding capacity designed to support late-phase and commercial cell therapy programs. The company previously partnered with Basilard BioTech on ex vivo gene delivery for T cell and iPSC therapies, establishing a pattern of technology integration partnerships alongside its core CDMO services.