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hiPSC-based Cell Therapy

Ncardia is uniquely specialized in early-stage process development and manufacture of cell therapies based on human iPSC technology. Our demonstrated expertise in iPSC generation and differentiation protocol development makes us well positioned to partner with innovative cell therapy developers to establish novel advanced therapies.

Process Development

Over 15 years of experience in developing manufacturing processes for induced pluripotent stem cells has equipped us with the experience to design and optimize manufacturing procedures that deliver quality products to scale.

Ncardia has established history in cardiovascular and CNS cell model development and manufacture, which has expanded to include a variety of additional therapeutically interesting cell lineages. We utilize Quality by Design (QbD) approaches for cost-effective and rapid process development to scale.

Scalable Manufacturing

iPSC technology provides a renewable resource for the consistent manufacture of well-defined cell therapies. We partner with clients to establish robust manufacturing processes that can be reproduced reliably at scale in the most cost-effective manner.

Our manufacturing procedures utilize proven bioprocessing technologies for adherent and suspension approaches. All reagents and processes are subject to a quality control system and standard operating procedures. Final product and in-process quality testing, such as identity and functionality assays, are employed for product release. Cell culture media are typically fully defined to ensure robust processes that yield functional cells.

Commercial ready

A successful manufacturing process is reproducible, cost effective, and compliant. We plan for success from the initial process development stage by addressing early the common challenges in advancing a cell therapy product beyond the preclinical phase.