Allele Biotech

Allele Biotechnology and Pharmaceuticals, Inc. operates as a Contract Development and Manufacturing Organization (CDMO) and a key supplier of molecular biology reagents, positioning itself at the intersection of research tools and therapeutic development. Founded in 1999 by Dr. Jiwu Wang, a biochemist with a Ph.D. from the University of Southern California and extensive experience in molecular biology, the company leverages its scientific roots to serve biomedical researchers and pharmaceutical partners. Dr. Wang's research background in pre-mRNA splicing and his numerous patents in RNA interference, imaging, and stem cell production have fundamentally shaped the company's trajectory.

The company's business model is multifaceted, generating revenue through the sale of proprietary research products, technology licensing, and offering comprehensive CDMO services. Its client base ranges from academic researchers to large pharmaceutical companies like Astellas. A cornerstone of Allele's offerings is its induced Pluripotent Stem Cell (iPSC) technology. The company has developed patented, feeder-free methods using messenger RNA (mRNA) to create clinical-grade iPSC lines, which are crucial for developing cell therapies for conditions such as diabetes and spinal injuries. Allele established a cGMP-compliant facility in San Diego to produce and bank these iPSC lines, offering both off-the-shelf and custom cell line development.

Another significant area of operation is the development of single-domain nanoantibodies (nAbs) derived from camelids. These small, highly stable antibodies offer advantages in specificity and tissue permeability, making them suitable for diagnostics and as biologics in immunology and oncology. Allele's involvement in this field dates back to 2008. Furthermore, the company is known for its high-performance fluorescent proteins, most notably mNeonGreen, which is considered one of the brightest monomeric fluorescent proteins available and is used extensively in biomedical imaging and research. The intellectual property surrounding mNeonGreen led to patent infringement lawsuits against major pharmaceutical companies for its unauthorized use in COVID-19 research. During the COVID-19 pandemic, Allele utilized its iPSC and nanoantibody platforms to develop diagnostics and therapeutic candidates.

Keywords: Contract Development and Manufacturing Organization, CDMO, molecular biology reagents, induced pluripotent stem cells, iPSC manufacturing, mRNA reprogramming, cell therapy, nanoantibodies, nAb, fluorescent proteins, mNeonGreen, Jiwu Wang, regenerative medicine, drug discovery services, cGMP manufacturing, biomedical research tools, stem cell banking, genome editing, immunology, oncology therapeutics