ASC Receives Drug Manufacturing License from the California Food and Drug Branch | ASC
Milpitas, California, August 3, 2021 --
Applied StemCell, Inc.’s GMP facility is Now Fully Licensed and Ready for Drug Product Manufacturing.
Applied StemCell (ASC), a fast-growing Gene & Cell Therapy CRO, today announced that the California Department of Public Health, Food and Drug Branch (FDB) has approved its new GMP facility and is now fully licensed to provide Good Manufacturing Practice (GMP)-grade induced pluripotent stem cell (iPSC) services and products. ASC’s state-of-the-art GMP facility includes manufacturing space, a storage area for raw and finished products, and support lab rooms. The brand new GMP facility is equipped for iPSC generation, expansion, gene editing, and differentiation as well as general cell banking processes.
“Following the approval of our GMP facility, we are very excited and prepared to provide GMP drug manufacturing services to companies seeking to produce clinical-grade and commercial iPSC products,” said Ruby Yanru Chen-Tsai, Chief Executive Officer of Applied StemCell. “We look forward to working with new partners to develop and manufacture high-quality iPSC-derived therapeutic products to address the need for novel cell therapies to treat diseases without effective treatments.”
About Applied StemCell, Inc.
Applied StemCell, Inc. is a leading gene editing and stem cell therapy CRO company located in Milpitas, California. ASC supports gene editing and stem cell therapy development processes with two high-impact platforms: CRISPR and TARGATT™ genome editing and stem cell technologies. ASC’s proprietary TARGATT™ technology enables site-specific, stable integration of large DNA fragments into a safe harbor locus more efficiently and faster, with guaranteed transgene expression without the disruption of internal genes and gene silencing. ASC licenses its TARGATT™ CHO, HEK293, and iPSC cell technology to pharmaceutical, biotechnology, and gene/cell therapeutic companies. For further information on the TARGATT™ technology, please visit: www.appliedstemcell.com
More information can be found at www.appliedstemcell.com.
Marketing Director, Applied StemCell, Inc.