From cell banking and directed differentiation to GMP-scale production — we partner with iPSC developers to build the manufacturing foundation for off-the-shelf cell therapies. One platform, multiple therapeutic products.
iPSC-derived cell therapies represent the future of off-the-shelf medicine — 106 companies, 32 clinical stage, 68 preclinical. Made Scientific partners with iPSC developers to build manufacturing platforms that support multiple differentiation pathways at GMP scale. Our teams understand iPSC biology, not just cell therapy manufacturing.
From cell bank creation through commercial-scale production of iPSC-derived cell therapies — a platform approach for off-the-shelf medicine.
GMP MCB/WCB creation with full characterization — pluripotency, identity, sterility, karyotype, genomic stability, and adventitious agent testing.
Protocol development for directed differentiation — cardiomyocytes, dopaminergic neurons, NK cells, T cells, beta cells, and other lineages.
GMP-compliant iPSC expansion and differentiation in purpose-built cleanroom suites — from adherent culture to bioreactor-scale suspension production.
Potency assays, identity testing, purity analysis, genomic stability monitoring, and release specs tailored for iPSC-derived products.
Research to clinical to commercial — bioreactor optimization, media development, and process parameter definition for reproducible differentiation at scale.
IND-enabling packages addressing complex CMC requirements — tumorigenicity assessment, genomic stability data, and potency validation.
iPSC-derived therapies start from a single cell line and differentiate into the target cell type — cardiomyocytes, dopaminergic neurons, NK cells, T cells, beta cells. The manufacturing challenge isn't just one process; it's building a platform that supports multiple differentiation pathways at GMP scale.
Consistency is everything. Directed differentiation must produce the same cell type, with the same identity, purity, and potency, across every manufacturing lot.
Discuss your iPSC programMCB/WCB creation under GMP with extensive characterization: karyotyping, whole genome sequencing, pluripotency markers, sterility, and mycoplasma testing.
Directed differentiation must produce the target cell type with consistent identity, purity, and potency across lots. Lot-to-lot variability is the central manufacturing risk.
Transitioning iPSC expansion and differentiation from adherent culture to suspension bioreactors — maintaining cell quality while achieving commercial volumes.
Monitoring for karyotypic abnormalities, tumorigenicity risk assessment, and genomic stability across passages — critical for regulatory acceptance.
Our GMP facilities are designed specifically for cell therapy and actively support concurrent iPSC and cell therapy programs across development stages.
Made Scientific Headquarters
Located at the heart of innovation in Princeton, New Jersey, our 60,000 ft² facility is equipped to take your therapy from early development to GMP manufacture.
Made Scientific Clinical Production
Strategically designed for flexibility, our Newark site offers 15,000 ft² of GMP-ready space to support client-dedicated and hybrid operational models.
Workforce Development & Training
We're investing in the future of cell therapy through both hands-on and digitally accessible GMP-inspired training. Located on the NJIT campus, our center has supported over 275 trainees across industry and academia.
Platform-ready manufacturing infrastructure for iPSC programs at every stage.
All Clients
Full-service iPSC manufacturing in Made's GMP suites. Cell banking, differentiation, and production — your team maintains oversight and process ownership.
Mid-to-Late Stage Clients
Your scientists work alongside ours. Critical for iPSC programs where differentiation protocols and biology knowledge must transfer with the process.
Late-Stage and Commercial Clients
Dedicated iPSC suites designed around your platform — from cell banking infrastructure to multi-lineage differentiation and scale-up systems.
One iPSC line can generate multiple therapeutic products. We build manufacturing platforms — not one-off processes — so your cell banking investment supports every differentiation pathway in your pipeline.
Our infrastructure is designed for the lot sizes, cryopreservation requirements, and inventory management that off-the-shelf allogeneic products demand.
Our analytical team develops the assays — potency, identity, genomic stability, tumorigenicity — that regulators expect for iPSC-derived products.
iPSC programs have long development timelines. We're structured for multi-year partnerships — from cell bank creation through process development, clinical supply, and commercial manufacturing.
Have a question for our sales team? Contact us to explore how our expertise and capabilities can help you achieve your goals.
Contact Us