Allele Biotechnology & Pharmaceuticals, Inc. has purchased a new facility for the cGMP production of clinical-grade cells for cell therapy applications. Cells will be produced by Allele for industrial and academic partnerships, as well as its own efforts in the area of cellular therapeutics.

The 18,000 sq.-ft. facility, located near its headquarters in San Diego, CA, will be the center of production of human induced pluripotent stem cells (hiPSCs) using its synthetic mRNA platform technology. 

Allelle’s mRNA platform eliminates some of the drawbacks that are common to other technologies for making hiPSCs. For example, cells are produced with neither the random integration of foreign DNA nor the use of whole virus or virus-based elements. hiPSCs, as cells that have the potential to become any cell in the human body, holding great potential for therapies.

Allele recently made a number of advances regarding the differentiation of hiPSCs towards cells, such as neural progenitor cells, neurons, astrocytes, mesenchymal stem cells, cardiomyocytes, skeletal muscle cells, hepatocytes, and adipocytes. These cells would also be produced in the cGMP facility when intended for specific therapies.

“This dedicated facility will help us to realize a number of our visions in bringing the benefits of pluripotent stem cells to society,” said Jiwu Wang, Ph.D., president and chief executive officer of Allele. “The first step in helping people in need with all the stem cell technologies developed in labs is to clear a path to move them from bench to bedside, which requires high-quality, controlled production that can be monitored by the FDA. Together with our licensees, drug development partners, investors, and individuals who would like to participate in banking hiPSCs for research and therapy, we anticipate even faster pace in our business development in this area.”