uBriGene Launches Clinical iPSC Banks to Accelerate Regenerative Medicine and Cell Therapy Development

ROCKVILLE, MD / ACCESS Newswire / June 16, 2025 / uBriGene Biosciences, a leading cell and gene therapy CDMO, is proud to announce the launch of its fully characterized, ready-to-use induced pluripotent stem cell (iPSC) banks. Developed using uBriGene’s proprietary RNA-LNP reprogramming technology, these iPSC banks are now available to support research, translational development, and clinical applications worldwide.

uBriGene’s iPSC seed banks and master cell banks (MCBs) are generated in GMP-compliant cleanrooms using healthy donor fibroblasts sourced from the USA in full compliance with FDA regulations. Reprogrammed with a non-integrating mRNA-LNP kit, the iPSCs are free of genomic footprint and residual RNA.

Each bank undergoes rigorous quality control testing to confirm identity, genomic stability, sterility, the absence of adventitious viruses, and strong expression of stemness and pluripotency markers. Early-passage seed banks (P2-P5) and clonally derived MCBs are cryopreserved and released for use in a wide range of regenerative and allogeneic cell therapy programs.

“With our iPSC banks, clients can save 1-2 years and the uncertainty associated with donor cell sourcing and reprogramming,” said Dr. Xiulian Sun, CTO and Founder at uBriGene. “These banks are designed to accelerate preclinical and clinical workflows with regulatory confidence.”

uBriGene’s iPSC banks are now available in both research-use only (RUO) and GMP-compliant formats. Gene editing services are also available upon request to customize cell lines for disease modeling or therapeutic development.

To learn more about uBriGene’s iPSC bank offerings, visit: https://www.ubrigene.com/ipsc-products/ipsc-banks

About uBriGene
Founded in 2015, uBriGene Biosciences is a leading Contract Development and Manufacturing Organization for advanced therapeutic medicinal products (ATMPs). The company provides integrated CDMO and CRO solutions, encompassing services for cell therapy products, viral vectors, and RNA-related products, with in-house QC testing and regulatory IND filing. Our GMP-validated Maryland facility offers one-stop CDMO services from process development to manufacturing, driving global advancements in ATMPs.

SOURCE: UBRIGENE BIOSCIENCES INC

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