At Defined Bioscience, we are committed to supporting the advancement of cell and gene therapies with reagents that are not only high-performing but also manufactured under current Good Manufacturing Practices (cGMP). Our HiDef® B8 medium was specifically designed to deliver reproducibility, consistency, and safety — all critical requirements for clinical translation.
Recently, with support from the California Institute for Regenerative Medicine (CIRM) and work conducted at Allele Biotechnology & Pharmaceuticals Inc., we evaluated HiDef® B8 across multiple human pluripotent stem cell (PSC) lines. These studies confirmed that HiDef® B8 maintains genomic integrity and supports efficient differentiation into multiple lineages. Full results will be published later.
One powerful demonstration of this capability is shown in cardiomyocyte differentiation. Using a cGMP iPSC line from Pluristyx, Inc., our researchers successfully generated beating cardiomyocytes cultured in HiDef® B8 cGMP. These results highlight the potential of HiDef® B8 as a trusted foundation for both research and clinical development.
Beating cardiomyocytes derived from iPSCs grown in HiDef-B8:
Why cGMP and Defined Media Matter
For therapeutic applications, every step in the workflow must be standardized and reliable. cGMP-compliant defined reagents like HiDef® B8 help:
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Mitigate risk by eliminating animal-derived and undefined components.
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Streamline production by enabling consistent growth across PSC lines.
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Ensure quality and safety for cells intended for downstream clinical use.
As the cell and gene therapy field continues to grow, adopting defined, cGMP-ready tools will be essential for ensuring that promising discoveries can be efficiently and safely scaled into treatments. HiDef® B8 is purpose-built to help researchers and developers bridge that gap.
