EXOSOMES BY ANTEAGE®
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A REVOLUTION IN AESTHETICS
Exosomes train your cells to behave as if they were younger– which makes you look that way.
Exosomes are lipid nanoparticles that get secreted by cells. The cells in your body naturally create exosomes as a way to communicate with one another and to help regulate biological processes.
In addition to the exosomes your body creates naturally, exosomes can also be applied topically in order to dramatically enhance the results of clinical anti-aging treatments. These topically applied exosomes communicate with the cells in your body by producing biosignals.
UPGRADE ANY TREATMENT
Exosomes can maximize the results of almost any type of treatment, including:
Exosome Cell Sources
AnteAGE MDX® Exosome Solution is a first of it’s kind hybrid-source exosome solution. In order to understand exactly why this is important and how this innovative approach maximizes aesthetic outcomes, it is crucial to understand the science behind exosome types.
There is no “one cell type does all”, each and every cell type within the body is specialized (some more than others) to conduct specific tasks. Hair stem cells are excellent at forming new hair, cardiac progenitor cells are excellent at forming new heart cells. The same is true for BM-MSC and UC-MSCs. Each is slightly different and has slightly different “areas of excellence.”
Combining exosomes from two cell types maximizes the benefits of similar yet distinct stem cells in a single treatment.
Bone Marrow Stem Cells are the most studied adult stem cell type and have demonstrated potent anti-inflammatory functions. Umbilical Cord Stem Cells are derived from a physiologically younger tissue and are therefore a much younger cell type. These young adult stem cells demonstrate anti-inflammatory effects and also significant proliferation and extracellular matrix production (collagen, elastin, HA). Combining these two stem cell exosomes gives the best opportunity for a maximal regenerative effect on the skin.
Why We Lyopholize Our Exosomes
What Is Lyophilization?
Lyophilization or freeze drying is the process of removing water from a frozen sample under vacuum. Water is removed via sublimation, resulting in a dry, water-free product that can be stored for extended periods of time. Lyophilization is used for the storage of proteins, tissues and even foods.
During the process of sublimation proteins can lose their structure and become damaged. Exosomes that are lyophilized with no cryoprotectant rupture, leak their contents, lose their 3D spherical shape and lose their function. To stop this damage the use of cryoprotectants such as trehalose can preserve the structure and viability of exosomes during the lyophilization process. Trehalose is a sugar molecule made up of two glucose molecules. During the sublimation as water is removed from the sample the trehalose molecule acts as a stabilizer to help retain the 3D structure of the exosomes. There are many research studies that demonstrate the beneficial effects of lyophilizing with trehalose where exosomes have been stored for long periods of time and still retain their structure and function once reconstituted.
Benefits of Lyophilization
Removing water from a solution of exosomes significantly increases the shelf life and stability of the exosomes over time. Alternative methods for exosome storage are freezing at -80°C; this has demonstrated promising results but requires specialist equipment and shipping using dry ice making this not feasible for the cosmetic market. Freezing exosomes in solution at -20 addresses the specialist equipment but has demonstrated extremely low recovery of exosomes after thawing (REF). This therefore is considered a far from idea method for exosome storage within the extracellular vesicle community. Storing exosomes in a refrigerator at 4°C is extremely practical but data demonstrates a significant and rapid loss of intact vesicles over time. Therefore, the 10B exosomes that are added to each vial would rapidly decrease therefore significantly reducing the effect the lesser number of exosomes would have when applied to the skin.
Lyophilization overcomes these limitations by allowing long term storage (9 month shelf life) of exosomes with little reduction in exosome number once the treatment is applied. Storing the lyophilized exosomes in a refrigerator at 4°C adds an additional level of control in minimizing any temperature fluctuations that may cause exosome degradation.
Exosome Manufacturing Process
AnteAGE MDX® exosomes are isolated from the conditioned media of both bone marrow and umbilical cord mesenchymal stromal cells (BM-MSC & UC-MSC). From culturing the cells, collecting the conditioned media, purifying the exosomes, characterizing the exosomes, lyophilizing the finished product, quality control and regulatory check points, and filling and labelling vials all takes place in our state of the art exosome laboratory in Irvine, California.
Isolating the Exosomes
The exosomes are isolated from the BM-MSC and UC-MSC in the same way. Cell cultures are initiated in our class 5 ISO certified clean room, cells are seeded into flasks and cultured is xeno free medium. Cells are expanded into bioreactors to allow for the maximum number of cells from an initial culture. Cell culture media is replaced with a chemically defined low particle media for the production of stem cell conditioned media rich in exosomes.
Filtering & Filtration
Exosome rich conditioned media is chemically defined and contains no additional human or animal serum that can be a source of contaminating exosomes. Therefore all purified exosomes are known to have originated from the secreting stem cells. The exosome rich conditioned media is concentrated ~100x using tangential flow filtration (TFF); reducing the media volume from approximately 10L to 100mL. The membrane and pore size of the TFF system allows for small soluble proteins and water to be removed while retaining larger complex’s such as exosomes.
Purifying the Exosomes
The 100x concentrated conditioned media is then loaded onto a size exclusion chromatography (SEC) column to further purify the exosomes from the contaminating soluble proteins. Exosomes are purified in a salt buffer containing the cryoprotectant, Trehalose. Trehalose is important for the retention of vesicle structure following the lyophilization of each treatment vial.
Characterization
Exosomes are characterized based on the ISEV minimal experimental requirements 2014 & 2018. Particle (exosome) concentration is determined by nanoparticle tracking analysis and exosomes are diluted and vials filled to contain 14 billion exosomes in each vial. Vials are rapidly frozen before lyophilization. Lyophilization occurs over 12 hours before septas are automatically compressed under vacuum. After lyophilization, at least 90% of the original 14 billion exosomes remain viable, allowing for a minimum of 10 billion viable exosomes per vial for the entire shelf life of the solution.
Being in control of the complete manufacturing, quality testing and lot release allows AnteAGE® to produce a highly regulated, controlled, reproducible, and safe product for aesthetic use. Every lot undergoes rigorous testing prior to release including: sterility, endotoxin and exosome characterization and function in a number of different model systems. Prior to shipping, vials are stored in a temperature controlled environment and shipped with a cold pack to minimize any temperature fluctuation and ensuring a quality and reproducible product.
Exosome FAQ’s
Understanding the Science
Exosomes are small, nanometer-sized vesicles that play a critical role in cellular communication and the regulation of biological processes within the human body. Despite their small size, exosomes have the ability to carry a variety of important biomolecules, including proteins, lipids, and genetic material, making them a powerful tool for cell-to-cell communication and regulation.
Due to the way in which exosomes are formed, they are very representative of the cells that they are released from. Exosomes secreted from stem cells demonstrate potent regenerative / repair properties when applied to damaged or wounded tissue. It is this reparative function of stem cell exosomes that we exploit in AnteAGE MDX.
Exosomes play a critical role in the maintenance of tissue homeostasis by regulating cell proliferation and differentiation. By transmitting growth factors, cytokines, and other biologically important molecules, exosomes help to coordinate the activities of cells and maintain normal tissue function. In aesthetics, cell turnover, repair and rejuvenation are critical in anti-aging treatments.
Safety & Efficacy
We control 100% of the cell culturing and manufacturing in-house. The entire process takes place in our GMP Certified, Irvine, California laboratory. Our attention to each and every detail in the manufacturing process allows us to confidently deliver an extremely potent, effective, and most importantly, safe treatment solution.
No. Just like our other Growth Factor Treatment Solutions, stem cells are cultured in the laboratory to extract the cytokines and growth factors required to improve treatment outcomes. Then, the growth factors and cytokines are put through a filtering process which allows us to extract only the exosomes from the media.
There are no cells or cell remnants in any AnteAGE product.
The FDA does not regulate cosmetic treatments for topical use. As a result, there are currently no aesthetic exosome treatment solutions approved by the FDA in the market today.
Exosome Solution
Through intentional testing and quality control efforts across every step of our exosome manufacturing process and our state of the art nanoparticle analysis equipment, we are completely confident that each vial contains at least 10 Billion viable exosomes for the entirety of its shelf life.
The AnteAGE MDX® Exosome Solution is manufactured from start to finish in our state of the art exosome laboratory in Irvine, California.
The AnteAGE MDX® Exosome Solution is a first of it’s kind, state of the art, hybrid exosome solution containing exosomes derived from human bone marrow mesenchymal stem cells as well as human umbilical cord derived stem cells. This hybrid approach offers a whole new level of stability and efficacy.
AnteAGE MDX® Exosome Solution contains 10 billion exosomes packed with regenerative growth factors and cytokines.
AnteAGE MDX® Exosome Solution does not contain fillers, making it a pure exosome solution. Because we do not include fillers or other ingredients in this solution, the 10 billion exosomes housed in the Exosome Solution vial are almost invisible to the human eye.
Exosome Solution Ingredients:
Phosphate buffered saline, Human Bone Marrow Stem Cell Exosomes, Human Umbilical Cord Stem Cell Exosomes, Trehalose
Diluent Ingredients:
Water (Aqua), Hyaluronic Acid, Dehydroacetic Acid, Benzyl Alcohol
EXOSOME LABORATORY
We proudly manufacture our Exosome Solution, from start to finish, in our state of the art exosome research & production laboratory in Irvine, California.
In order to maintain the highest level of safety and purity, we handle 100% of the production of our AnteAGE MDX® Exosome Solution in our Irvine, California laboratory. From isolation and extraction to final vial filling, the final treatment solution does not leave our class 5 ISO certified clean room until the vial has been sealed and is ready to be delivered to the patient.
We also are leveraging this state-of-the-art laboratory to perform additional research and development for future products and exciting new growth factor and exosome technologies for aesthetic application.
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