Market Overview

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


Allele Biotechnology & Pharmaceuticals Inc. 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

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

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

Established in 1999, Allele Biotechnology's mission is to further
therapeutic innovation and support clinical studies by providing cutting
edge technologies and clinical-grade solutions to partners in the stem
cell therapy arena.

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