Streamlined regulatory documentation accelerates development of next generation therapies

Pluristyx, a leading provider of innovative, unmodified, and gene-edited induced pluripotent stem cell (iPSC) lines, submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its PluriBank™ CG (Clinical Grade) iPSC lines. This comprehensive regulatory submission details chemistry, manufacturing, and controls (CMC) for making the PluriBank™ CG iPSC products, simplifying regulatory oversight and enabling customers to use these clinical grade cell lines as starting material for developing advanced cell-based therapies.

The PluriBank™ CG portfolio includes the immediately available off-the-shelf PSXi013 line. Unlike other commercially available iPSC lines, PluriBank™ iPSCs are specifically designed and prospectively engineered to support complex gene editing without compromising genetic stability or stem cell potency. Pluristyx has pioneered a proprietary, non-integrating, footprint-free RNA reprogramming method, ensuring high reprogramming efficiency, genomic integrity, low passage number, and the absence of integrating DNA or viral vector—critical features for clinical applications. Pluristyx mRNA technology provides genetically stable iPSC lines at the lowest passage, maintained as a polyclonal population. Unlike other products that only offer a few pre-selected clones, PluriBank™ allows users to select the best clonal line optimized for their specific differentiation protocol, significantly expediting evaluation and manufacturing.

By using PluriBanks™ and the supporting DMF, partners can cut years from their development timelines through preclinical to clinical research and commercialization. Partners that license a PluriBank™ will receive a Letter of Authorization referencing the DMF in their FDA regulatory submissions to streamline the process.

Pluristyx authored the DMF with Advanced Regenerative Manufacturing Institute’s (ARMI) BioFabConsulting service which provided expert regulatory review and managed the submission to the FDA.

“The PluriBank™ CG DMF represents a significant advancement for the cell therapy industry,” said Dr. Richard McFarland, ARMI’s and BioFabUSA’s Chief Regulatory Officer. “Pluristyx’s well-characterized, GMP-compliant iPSC lines provide ‘off-the-shelf’ starting materials ideal for further gene editing and manufacturing. These lines enable partners to streamline IND preparation, develop innovative cell therapy products, and expedite progress toward clinical use.”

“We are excited to add this critical regulatory element to our revolutionary PluriBank™ cells reprogrammed with our proprietary RNA technology,” said Dr. Jason Carstens, Chief Operating Officer of Pluristyx. “Providing a DMF simplifies and de-risks regulatory submissions for stem cell-derived therapies. With PluriBank™’s CG DMF, partners can reference it to reduce costs and accelerate their path to the clinic.”

About Pluristyx

Pluristyx is a privately held, biotechnology company offering a wide range of products and services to support the development and manufacture of cell and gene therapies, including iPSC lines, proprietary genetic engineering technologies, differentiation services, iPSC culture kits, and contract development services. Pluristyx is committed to delivering highest quality products and services to accelerate clinical translation of life-changing cell therapies. For more information on Pluristyx visit www.pluristyx.com.

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