The 18,000sq ft facility in San Diego, California will become Allele Biotechnology & Pharmaceuticals’s production centre for its hiPSCs and, according to CEO Jiwu Wang, the plant is already partially equipped for the firm’s needs.
“A clean-room unit was already fully developed before we purchased it,” he told Biopharma-Reporter.com. “The second unit is a high-end R&D lab that will support a world-class lab within the Scintillon Institute in neural degenerate disease research, an area we would like to apply our iPSC and nano antibody technologies to.”
The site will make clinical-grade stem cells using the firm’s synthetic mRNA platform which Wang said avoids common problems associated with other stem cell generating platforms.
“Our technology is ‘footprint-free,’” Wang explained. “We send a message to the human adult cells telling them to go back to the embryonic stage as fully pluripotent stem cells, but do not iron the letters carrying the message permanently into the genome of the cells.
“Our stem cells are cleaner than those made by other technologies, and they can be generated within a much shorter time period, at a higher efficiency, and with minimum effort. This is ideal for large scale and personal stem cell production.”
Allele has seen rising demand for its platform as biopharma look to specialised cells for drug discovery and regenerative medicines, something Wang said was a driving factor in the purchase.
“Our initial interactions with large pharmaceutical companies regarding iPSC partnerships made it clear that the first step would be a cGMP production of iPSC lines integrating clinically viable technologies.
“We formed contacts with additional business partners after Ocata Therapeutics licensed Allele’s mRNA reprogramming technologies [in March]. We have also developed new business models of iPSC banking, where possibly FDA-regulated process will be critical for our customers.”
The new site will be fitted with mostly single use equipment, Wang added, though he was unavble to divulge any financial details surrounding the acquisition.