Manufacturing

How do we make Stem Cell Factors:

Stem Cell Factors (SCFs) are secreted by the ischemia-tolerant human mesenchymal stem cells (itMSCs). The cells are manufactured under conditions required by the cGMP regulations. We start by selecting a batch of mesenchymal cells exclusively licensed from Stemedica Cell Technologies, Inc. The cells are grown under physiological low-oxygen conditions (US Patent 8,420,394 entitled “Culturing Ectodermal Cells Under Reduced Oxygen Tension”), corresponding to their natural environment. In vitro experiments show that cells grown at physiological oxygen levels, in contrast to those grown in atmospheric oxygen (0.21 atm), secrete higher levels of growth factors and cytokines involved in angiogenesis and wound healing. Once cells reach optimal density, we stimulate production of angiogenic factors by lowering oxygen level to hypoxic levels (0.02 atm).

Preservation Technology:

StemProtein’s exclusive world-wide license to Preservation by Vaporization (PBV) technology enables us to transform SCFs into a heat stable product. PBV-preserved factors exhibit negligible decline in activity after 3-year storage at +25°C.

Preservation Ensures Product Potency

 

Safety:

We test our Stem Cell Factors (SCFs) for sterility and endotoxin throughout the manufacturing process. After final packaging, SCFs undergo terminal sterilization by electron beam radiation. A high dose of radiation (≥25 kGy) eliminates all concerns regarding transmission of small viruses that may pass through 200 nm bacterial filters.

We currently develop several formulations containing heat stable SCFs: wound dressings, mucoadhesive films and tablets, eye drops, nasal sprays, and a number of skin care products.