Allele Receives iPSC Patents Bolstering Current Production of Multiple Lines at Wholly Owned cGMP Facility


Allele Biotechnology & Pharmaceuticals Inc. has received issuance notices from the U.S. Patent and Trademark Office for its first batch of patents covering the derivation of induced pluripotent stem cells (iPSCs). Allele’s proprietary technology uses only messenger RNA (mRNA) to reprogram human or other primate cells, avoiding many operational complications that other methods often encounter.

The patents were purposefully structured for the production of iPSCs using methods fully compliant with current good manufacturing practice (cGMP) regulations suitable even for phase III clinical trials and commercial production. Accordingly, the Allele team developed technologies to enable a feeder-free and genome integration-free reprogramming procedure with unparalleled efficiency and success rates.

“Companies in the iPSC industry, an industry still in its infancy, are able to access only 1 or 2 GMP-compatible lines and are often nervous about whether their highly valued differentiation protocols will work with these lines,” commented Dr. Jiwu Wang, CEO of Allele Biotech and a key inventor of these patents. “What we have put in motion starting this month is to continuously create fully cGMP-compliant iPSC lines. We intend to communicate with the FDA early and often to set high quality standards, which will enhance chances of success in the iPSC therapy field as a whole.”

Allele’s differentiation protocols also use mRNAs to direct cell fate. Because the costs of cGMP production are directly influenced by the time cells spend in culture, Allele’s efficient protocols will show a strong technical and economic advantage. Many academic labs and their spinoff companies have developed protocols to differentiate embryonic stem cells (ESCs) or iPSCs into a chosen lineage. Those protocols typically work well with just one ESC or iPSC line, whereas Allele’s protocols consistently work across all lines tested, ultimately enabling autologous cell therapies, which are widely considered to be the true power of the iPSC technology since its discovery by Dr. Shinya Yamanaka.

Operations are underway at Allele’s cGMP facility to produce dozens of iPSC lines. According to both industry and academic collaborators, lines produced using Allele’s methods are easier to maintain and use when compared to alternative pluripotent stem cells. In addition to internal projects, these iPSC lines and cell fate manipulation methods will be available via partnerships and licensing, providing companies with the most advanced iPSC technologies to further their therapeutic programs.