Overview
- The traditional ESC/iPSC culture approach proves problematic as its vulnerability to xeno-material contamination undermines its reliability and clinical usability.
- In place of liquid, using powder in the culture medium formula goes a long way toward facilitating transport and import/export. Moreover, a 3D (suspended) culture system and mechanistic cell dissociation are adopted to mitigate possible damage in the dissociation process.
- This reliable, serum-free approach can mitigate subculture mutation and bring down culture costs.
Development Process
Over the course of this project under the Applied Research Incubation Program, the team completed patent feasibility evaluation and market analysis, established product specifications for both powder and liquid media and conducted functionality assays, filed a 510(k) submission to the FDA, wrote a startup business plan, and planned a GMP-compliant manufacturing facility. Since the establishment of DuoGenic StemCells Corp. on March 22, 2018, BMCC has continued to offer assistance in product commercialization.