Applied StemCell Announces Drug Master File Submission to the US FDA for their GMP-Grade iPSC Cell Line

MILPITAS, Calif.--(BUSINESS WIRE)--Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its ActiCells™ GMP Human Induced Pluripotent Stem Cell (hiPSC) line. This milestone underscores the company’s commitment to empowering scientists to accelerate their cell therapy development by providing high-quality, regulatory-compliant iPSC solutions.

In addition to its ActiCells GMP hiPSC line, Applied StemCell is introducing a powerful iPSC line pre-engineered with their patented TARGATT™ landing pad at the H11 safe harbor locus. This innovation enables precise, site-specific insertion of as much as 20 kb of DNA in a single reaction, allowing for consistent, reliable expression of one or more genes. By combining GMP compliance with TARGATT™ technology, Applied StemCell offers cell therapy developers an efficient and scalable solution for engineering iPSCs to meet their specific therapeutic needs.

“Securing a DMF for our ActiCells GMP hiPSC line, along with introducing our ActiCells GMP TARGATT™ hiPSC Knock-in Kit, represents a major advancement for the cell therapy industry,” said Ruby Tsai, Ph.D., CEO at Applied StemCell. “By providing a fully characterized, regulatory-ready iPSC platform, we empower researchers to accelerate development while reducing manufacturing and regulatory hurdles.”

Applied StemCell’s GMP iPSC solutions support a wide range of regenerative medicine and cell-based therapy applications. With the added advantage of a pre-engineered TARGATT™ landing pad, developers can efficiently generate gene-edited cell lines with high efficiency and reproducibility, expediting the path to clinical and commercial success.

For more information on how Applied StemCell’s ActiCells GMP hiPSC line can advance your therapeutic development, please visit appliedstemcell.com or contact Pia Abola, Ph.D., Director of Marketing at Applied StemCell.

About Applied StemCell

Founded in 2008 to provide industry and academic researchers with the ability to leverage the power of induced pluripotent stem cell (iPSC) technology, Applied StemCell continues to use their innovative technology to power autologous and allogeneic discovery and development. Their products and services enable a full spectrum of studies from basic research to GMP manufacturing and biobanking—including disease modeling, library construction, drug screening, and nonclinical and pre-IND mouse studies—and their patented technologies ensure a clear IP path to commercialization.