Bell Biosystems declared the results of their latest preclinical safety study at the Biotech Showcase in San Francisco. The study managed to comply with USP <151> pyrogenicity guidelines that demonstrated the safety of intravascularly injected stem cells in rabbit subjects. In vivo pyrogen study demonstrated that Magnelle-powered(TM) cGMP manufactured human mesenchymal stem cells (hMSCs) do not elicit an in vivo pyrogenic response. Magnelle (magnetic organelle) contrast agents are being launched commercially this month, and create magnetic resonance imaging (MRI) beacons in a variety of cell therapies. Magnelle-powering(TM) of therapeutic cells has been shown in small animal studies to provide rich data on transplanted cell location and, unlike alternatives, on cell viability post-transplantation using non-invasive MRI thus benefiting the Cell therapy research scientists and biopharmaceutical development organizations to measure cell viability and durability after injection. Magnelle reagents are derived from non-pathogenic, Gram-negative bacteria that express one of six types of endotoxin or lipopolysaccharide (LPS), which can potentially induce life-threatening pyrogenic reactions depending on the detailed molecular structure of LPS isoforms. To assess this safety concern, Bell subcontracted Pacific BioLabs, Inc. to undertake the rabbit pyrogen study following USP <151>.
Dr. Caleb B. Bell III Founder and CTO at Bell commented: “We are extremely encouraged by the results of these latest safety assessments as a key step forward in the realization of this technology for labeling and tracking cellular therapies.”