Allele Biotech’s cGMP iPSCs Used as Packaging Factories for mRNA
January 02, 2021
San Diego, CA January 2, 2021 (Updated from an earlier BusinessWire news announcement)– Allele Biotechnology and Pharmaceuticals, Inc. (Allele) has leveraged mRNA technology for over a decade to create cGMP-grade induced pluripotent stem cell (iPSC) lines for regenerative medicine and oncology applications. These iPSCs, mimicking early human development, offer rapid expansion and unlimited passaging, making them ideal biomaterial “production factories.” Allele has pioneered a novel process to induce these actively dividing cells to produce significant quantities of extracellular vesicles containing both RNAs and proteins.
During the COVID-19 pandemic, Allele generated preliminary data demonstrating the packaging of SARS-CoV-2 antigen protein mRNAs in iPSCs and released in extracellular vesicles. These vesicles could potentially deliver both the mRNAs and their encoded proteins – a dual mRNA and protein vaccine, naturally packaged within cells.
This approach enables:
- Multiplexing: Delivering multiple vaccine mRNAs simultaneously, unlike current, mostly single-mRNA vaccines.
- Enhanced potency: Packaging multiple encoded proteins at the same time for a more robust immune response.
- Improved stability: Addressing current mRNA vaccine stability concerns, with Allele’s iPSC-derived vesicles showing mRNA integrity at 4°C for months, compared to -80°C requirements for some existing vaccines.
Furthering its pandemic response, Allele is developing a rapid COVID-19 antigen diagnostic utilizing llama nanoantibodies and proprietary bright fluorescent proteins. As recently highlighted in the San Diego Business Journal, some of these nanoantibodies are also being explored as blocking agents for nasally delivered COVID-19 prophylactics and treatments.
John Cancilla, email@example.com