Allele Receives Tissue Bank License for Manufacturing and Distribution of cGMP-compliant iPSCs

Allele Biotechnology & Pharmaceuticals has received a Tissue Bank License from the California Department of Public Health, making it the world’s first establishment to collect tissue for the manufacture and banking of induced pluripotent stem cells (iPSCs) for commercial applications.

Allele’s cGMP facility is dedicated to the generation, banking, and differentiation of iPSCs for therapeutic use and drug discovery. All tissues and cells are processed in a state-of-the-art cleanroom to satisfy FDA requirements for Phase III clinical trials and commercial production. The cleanroom’s modular space and adaptable design allow different areas to be dedicated to the manufacture of various iPSC-derived cells.

The first tissues were processed in August 2017 when the cGMP manufacturing suite officially opened after a 2-year construction and remodeling effort and nearly a decade of iPSC reprogramming research and optimization. The iPSCs generation process is fully cGMP- and GTP-compliant, beginning with the onsite collection of tissue from donors or clients by a physician. All cGMP manufacturing personnel have undergone extensive training with strict qualification and documentation measures to ensure successful reprogramming of cells in an ISO-5 environment. Once generated, iPSCs are banked and can be distributed or differentiated for transplantation into patients. The entire process is validated and performed under the umbrella of a 21 CFR-compliant quality system.

Generation of iPSCs is based on Allele’s proprietary mRNA-only protocol which was designed and optimized expressly for cGMP production. The methods were developed to produce iPSCs that are free from genomic integration of plasmid DNA, viruses, and feeder cells. According to CEO and the lead scientist behind the technology, Dr. Jiwu Wang, “The powerful mRNA technology developed by Allele’s researchers made it much easier for cells to enter clinical trials down the road and we expect multiple patent issuances shortly.”

The cGMP facility has a dedicated mRNA production area for the manufacture of cGMP-compliant mRNAs. In addition to supporting iPSC reprogramming efforts, cGMP mRNA will support ongoing internal development programs to generate iPSC derived cells. Current efforts are focused on the development of pancreatic beta cells, neurons, oligodendrocytes and their progenitor cells, hepatocytes, muscle cells, and mesenchymal cells.

Established in 1999, Allele Biotechnology has a mission to further therapeutic innovation by providing cutting edge technologies and clinical grade solutions to partners working in collaborative and creative ways to support preclinical studies and clinical trials in the stem cell therapy arena.