The StemProtein Advantage
StemProtein manufactures Stem Cell Factors (SCFs) for pharmaceutical use in a variety of treatment, preventative, and/or health-maintenance products. StemProtein’s patented platform technology produces SCFs from ischemic-tolerant mesenchymal stem cells (itMSCs).
Stem Cell Factors (SCFs) are extracted from human bone marrow-derived mesenchymal stem cells (MSCs). The cells are manufactured in an FDB-licensed facility that follows cGMP regulations and is authorized by the FDA for clinical trials under a number of Investigational New Drug Applications (INDs). SCFs are controlled for endotoxin contamination and sterility several times during manufacturing. Nutrient supplements, such as human insulin and bovine serum, are removed from the final stages of manufacturing. The packaged product undergoes terminal sterilization by using a high dose of electron beam radiation (≥25 kGy). SCFs intended for topical applications are formulated as sterile single-use vials, which eliminates the need for bacteriostatic agents that may cause skin irritation.
The spectrum of bioactive protein secreted by itMSCs is complex. We quantitatively measured approximately 70 different proteins using multiplex protein arrays. In each gram of dried product containing mainly sucrose, we identified 35 different cell-secreted proteins in over 0.5 nanogram quantities. We routinely monitor the concentrations of VEGF, HGF, IL-6, CCL2, CXCL5, and CXCL8, in our product, as published literature has identified the important biological activity of these growth factors, cytokines, and chemokines [ref 1
; ref 2
]. Because tissue regeneration critically depends on adequate blood supply, we use in vitro
angiogenesis assays to evaluate the therapeutic potency of our stem cell factors.
StemProtein obtained an exclusive license to use "Preservation by Vaporization" technology (PBV) for stabilizing macromolecules at ambient temperatures (25°C to 45°C). PBV is a cornerstone of the VitriLife® approach to stabilization and delivery of fragile biologicals such as live vaccines. More facts about PBV and VitriLife® can be learned at www.vitrilife.com
. PBV is a vacuum foam drying process that immobilizes macromolecules in a hard "glass-like" matrix that protects the molecules from degradation. In tests, concentration of foam dried vascular endothelial growth factor (VEGF-A) showed no signs of decline after 36-month storage at +25°C.
Preservation technology allows formulation of factors for various applications that are suitable for intravenous, intranasal, and sublingual delivery. Dried SCFs can be ground into a fine powder that can also be incorporated into various topical formulations (cosmetic gels, wound dressings, hydrogels, a needle patch, etc.) as well as eye drops and nasal sprays.