Faster Clinical Translation and Commercialization of Therapies Derived From iPSC Technology
GERMANTOWN, MARYLAND / ACCESS Newswire / March 4, 2025 / uBriGene Biosciences (uBriGene), a leading cell and gene therapy CDMO, is pleased to announce the submission of its Drug Master File (DMF) for its innovative iPSC Reprogramming mRNA-LNP Kit. This comprehensive regulatory submission details the manufacturing and characterizations of the iPSC Reprogramming mRNA-LNP Kit.
uBriGene's mRNA-LNP reprogramming kit allows efficient reprogramming of somatic cells to iPSCs. The Drug Master File submission is expected to facilitate faster clinical translation and commercialization of therapies derived from iPSC technology.
The iPSC Reprogramming mRNA-LNP Kit represents a cutting-edge platform designed to reprogram somatic cells into induced pluripotent stem cells (iPSCs) using non-integrative mRNA and lipid nanoparticle (LNP) technology. Available in both research-grade and GMP-grade formats, the kit offers a robust, reliable method for generating high-quality iPSCs, reducing risks associated with genomic integration and ensuring enhanced reprogramming efficiency. The kit has been successfully applied in reprogramming fibroblasts or PBMC into iPSCs.
"Our DMF submission for the iPSC Reprogramming mRNA-LNP Kit is a testament to our rigorous quality control and innovative approach to cell therapy development," said Dr. Sun, CTO at uBriGene Biosciences. "This milestone not only helps streamline regulatory documentation and accelerate therapeutic programs for our clients, but also reinforces our leadership in delivering advanced, compliant solutions for iPSC reprogramming."
The DMF submission includes a comprehensive dossier detailing the product's manufacturing processes, quality control testing, and regulatory compliance, ensuring that the iPSC reprogramming platform meets the stringent standards set by regulatory authorities. This step is expected to facilitate faster clinical translation and commercialization of therapies derived from iPSC technology.
uBriGene Biosciences continues to invest in next-generation cell and gene therapy solutions, offering an extensive portfolio of services that include custom GMP manufacturing, analytical testing, and regulatory support. For more information about the iPSC Reprogramming mRNA-LNP Kit and uBriGene's full suite of CDMO services, please visit https://www.ubrigene.com/ipsc-products/ipsc-reprogramming-cocktail/.
Contact Information
Mingjuan Liu
Director of Marketing
contact@ubrigene.com
800 663 2528
SOURCE: uBriGene Biosciences Inc.
