One of the more common questions we receive about our AnteAGE MDX® Exosome Solution is, "How can you be sure that there are ten billion exosomes per vial?"
The question is a valid one. In a world where each of us is accustomed to hearing outrageous marketing and advertising claims, it is easy to brush off this type of data as some sort of estimate or average. However, the truth is that we have put significant measures in place to ensure that this isn't just a marketing claim– but a scientifically verifiable fact that can be replicated in any lab with the proper equipment.
Each batch of exosomes we culture and produce goes through a specific, thorough testing and quality control process that ensures safety, efficacy, and alignment with all product specifications we advertise.
Once a new batch has been cultured, that batch is tested using a technology called nanoparticle tracking analysis. This process allows us to determine the total exosome count for the entire batch of media. (Particle Concentration/mL x Volume)
Once the total particle count for the batch has been determined, the batch is then divided evenly by 14 billion– meaning that we fill each vial with 14 billion exosomes until the entire batch has been distributed. It is important to note that the vials are filled with 14 billion (despite our advertised 10 billion) to account for the loss marginal loss of exosome viability that occurs through the lyophilization process and over the entire shelf life of the product– meaning that each vial still contains 10 billion viable exosomes on the final day of its shelf life.
The vials of 14 billion exosomes are then lyophilized. Our data has consistently and reliably shown that 90% of the exosomes in each vial retain viability after lyophilization, leaving each lyophilized vial with more than 12 billion+ viable exosomes. The difference between the 12 billion+ exosomes that each vial has immediately post-lyophilization and the advertised 10 billion is to ensure that each vial exceeds the 10 billion exosome mark even on the final day of its shelf life.
Once the batch has been lyophilized, a handful of vials are randomly selected for another round of nanoparticle tracking analysis and additional quality control measures. If any of these vials contain fewer than 12 billion exosomes, or does not pass any of our other quality control standards, the entire batch gets discarded immediately and not a single vial from that batch will enter the market.
Why It Matters
As a leader in growth factor and exosome therapies for regenerative aesthetics, we believe it is our responsibility to uphold rigorous quality standards and to ensure that anything we say about our products can be verified by independent labs.
We have heard feedback from many other brands who claim that "it is not possible to say with confidence how many exosomes are in each vial." If a brand does not believe it is possible to quantify exosome counts on a per product basis, we cannot help but think to ourselves how that brand can call any of their products an exosome product in the first place.