The company believes our manufacturing expertise and experience differentiates us from other microbiome companies. First, we are only making a single strain as opposed to a consortium, which means we only have one thing to test and evaluate. Second, we the know the biological activity of that strain making potency testing reliable and repeatable. Lastly, we have been producing commercial scale product for several years and have been able to perfect our process and protocols over time.
AOB has developed a robust process to manufacture, scale, test and bottle ammonia oxidizing bacteria for both consumer and clinical use. We make mono-sterile products – products that contain a single strain of live bacteria that contains no other bacteria. We are the sole supplier of Mother Dirt AO+ Mist and we continue to develop and scale our expertise. We use the same manufacturing process to make our clinical products which is currently used in our clinical studies. To date we have made over 140,000 bottles with timelines associated with fulfilling consumer demand as well as the demands of clinical supply. We do extensive product testing for contamination through out the process to ensure our products are free from bio-burden outside of our intended bacterial strain.
As we grow we are optimistic about the ability to scale. We started with a one liter fermenter and have scaled as high as 100 liters and will be supplying our upcoming Phase 3 trials from a 50 liter fermentation process. We have also moved our manufacturing locations multiple times, leading us to believe that the process is robust. This may become critical as our therapeutic demands expand geographically.
The company continues to invest in its manufacturing capabilities, including facilities, team and intellectual property.