uBriGene Biosciences Submits DMF for iPSC Reprogramming mRNA-LNP Kit

• uBriGene Biosciences has submitted a Drug Master File (DMF) for its iPSC Reprogramming mRNA-LNP Kit, detailing its manufacturing and characterization.

• The kit, available in research-grade and GMP-grade formats, enables the generation of high-quality induced pluripotent stem cells (iPSCs) using non-integrative mRNA and lipid nanoparticle (LNP) technology.

uBriGene Biosciences (uBriGene), cell and gene therapy CDMO has announced the submission of a Drug Master File (DMF) for its iPSC Reprogramming mRNA-LNP Kit. The regulatory filing outlines the product’s manufacturing processes, characterization, and compliance with quality standards.

The iPSC Reprogramming mRNA-LNP Kit is designed to convert somatic cells into induced pluripotent stem cells (iPSCs) using a non-integrative mRNA and lipid nanoparticle (LNP) platform. By avoiding genomic integration, the kit offers a reliable and efficient reprogramming method, minimizing potential genetic risks. It is available in both research-grade and GMP-grade formats and has been successfully used to reprogram fibroblasts and peripheral blood mononuclear cells (PBMCs) 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 submission provides regulatory authorities with detailed information on the kit’s production, quality control measures, and compliance protocols. This step is expected to facilitate the clinical translation and commercialization of iPSC-based therapies by simplifying regulatory approval processes for clients using the platform.