uBriGene Biosciences, a leading cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has announced the launch of its fully characterized, ready-to-use induced pluripotent stem cell (iPSC) banks. The banks, developed using the company's proprietary RNA-LNP reprogramming technology, are now available to support research, translational development, and clinical applications worldwide.
Manufacturing and Quality Standards
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. The cells are reprogrammed using a non-integrating mRNA-LNP kit, ensuring the iPSCs are free of genomic footprint and residual RNA.
Each bank undergoes rigorous quality control testing to confirm multiple critical parameters including 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.
Clinical Development Acceleration
"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."
The time savings represent a significant advantage for companies developing cell therapies, as the traditional process of sourcing donor cells and establishing iPSC lines can be lengthy and unpredictable.
Product Offerings and Customization
uBriGene's iPSC banks are available in both research-use only (RUO) and GMP-compliant formats to meet different development needs. The company also offers gene editing services upon request to customize cell lines for disease modeling or therapeutic development applications.
Company Background
Founded in 2015, uBriGene Biosciences operates as a Contract Development and Manufacturing Organization specializing in 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 quality control testing and regulatory IND filing capabilities. The company's GMP-validated Maryland facility offers comprehensive CDMO services from process development through manufacturing.
