Allele acquires cGMP facility to produce clinical-grade cell therapy products


The facility will be used to produce human induced pluripotent stem cells (hiPSCs) using the company’s proprietary synthetic mRNA platform

Allele Biotechnology & Pharmaceuticals has purchased a new facility for the cGMP production of clinical-grade cells for cell therapy applications.

The 18,000ft2 facility, located near Allele’s headquarters in San Diego (California, US), will produce human induced pluripotent stem cells (hiPSCs) using the company’s proprietary synthetic mRNA platform, a technology that generates hiPSCs with neither the random integration of foreign DNA nor the use of whole virus or virus-based elements, drawbacks that are common to other hiPSC technologies.

Such ‘footprint-free’ cells will be produced by Allele for industrial and academic partnerships, as well as Allele's own efforts in the area of cellular therapeutics.

hiPSCs, as cells that have the potential to become any cell in the human body, hold great promise for therapies that can alleviate or cure human disease. To this end, Allele has recently made a number of advances regarding the differentiation of hiPSCs towards cells of specific lineages, such as neural progenitor cells, neurons, astrocytes, mesenchymal stem cells, cardiomyocytes, skeletal muscle cells, hepatocytes and adipocytes, including brown fat cells.

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‘This dedicated facility will help us to bring the benefits of pluripotent stem cells to society,’ said Dr Jiwu Wang, President and CEO of Allele. ‘The first step is to move these technologies from the bench to the 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 bank hiPSCs for research and therapy, we anticipate accelerated business development in this area.’