Cultivating high quality exosomes requires many steps. Evovex uses the most differentiated manufacturing and testing techniques to deliver a safe and standardized product. Our 9-step patent pending process outlined here, shows why hands down, Exovex stands out from the crowd.
Tissue Sourcing The source of the tissue is an important first step to ensure the highest quality tissue is obtained. Evovex places a high standard on its inclusion and exclusion criteria. The exosomes or extracellular vesicles (EVs) are derived from the chorion of placental mesenchymal stem cells, originating from the cytoplasm of the cell. These EV’s act as messenger systems and provide a rich source of molecules, including mRNA , miRNA, and growth factors, from cell to cell. Most other exosome manufacturers use the whole tissue for sourcing. While this may sound impressive, science shows that there is not scientific evidence for the usefulness of this approach.
Tissue Testing Once the tissue is sourced, rigorous testing is performed to determine the serology and sterility of the product. Testing of Evovex ensures the product is completely free of any stem cells. This step is important to ensure the final product does not trigger an immune response or other untoward effects in the receiving patient. Polymerase Chain Reaction (PCR) is used in this step for confirmation of quality. PCR allows for rapid isolation and quantification of any RNA present in the exosome, irrespective of the particle size.
MSC Sorting and Selection A process known as fluorescence-activated cell sorting (FACS) is used to purify specific cell populations based on phenotype. Flow cytometry allows detection of certain glycoproteins and other signaling molecules. Exovex utilizes positive markers such as CD44, CD73, CD90, CD105 and CD146 in its product but excludes negative hematopoietic markers CD34, CD45 and endothelial marker CD31. This level of sorting and selection allows Evovex to create a high quality and consistent product. It is this step that allows Exovex to customize the rich source of growth factors found in its final product.
Expanding MSCs Once the cells are single cell sorted, they are cultured and allowed to expand for growth. The cells are allowed to continuing growing until an optimized confluence is achieved. Cells are then further assessed for freedom from contaminants.
Seed and Grow Cells are then seeded where they are further cultured for cell culture activities. This is the first stage of cell attachment. The efficiency and distribution of this process is an important step that affects the final biological performance of the exosome. Cell proliferation at this stage is homogenous.
Collect Exosomes The nanoparticles now go through an ultrafilter at 0.22 µm. The process of filtration requires additional care to preserve the biological protein components including RNA and other growth factors.
Release Exosomes PCR is now performed to ensure the serology and the sterility of the product. The RNA is now profiled and readied for next generation sequencing.
Characterize Exosomes This process provides highly detailed analysis of the exosome to ensure safety, efficacy, purity, and strength. This is where Exovex stands by its product for producing consistent, high standard, highly specialized exosomes. This process is performed by a third party that includes Next Generation Sequencing (NGS), Multidimensional Protein Identification (MUDPIT) and Nanoparticle Tracking Analysis which determines the particle size and concentration of the sample. Some of the samples are studied under electron microscopy laboratory at UCLA. MUDPIT identification uses a non-gel technique to identify individual components of complex proteins and peptides. The process is performed in line with a tandem mass spectrometer to determine the protein content of the original sample.
Adjust and Optimize As a final step, Exocel then performs invitro sampling for standardization and qualification of the final product through UCSC.
This lengthy and advanced production process is what makes Exovex stand out amongst its competitors. The final product has a spherical morphology, and contains over 450 growth factors and miRNA for a consistent and reliable potency.
Exovex stands by its product because it has the most differentiated manufacturing and testing process. Exovex is quickly becoming the preferred option for aesthetic providers.
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