Drug Master File for iPSC Reprogramming mRNA-LNP Kit
March 4, 2025
GERMANTOWN, Md., March 04, 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.
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.
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.
uBriGene Biosciences
Mingjuan Liu
Director of Marketing
800-663-2528
contact@ubrigene.com