We have demonstrated 35–120% product titer improvements when FunctionMAX™ TiterEnhancer was added on top of existing processes or as a partial feed replacement, resulting in a lower total proportion of feed addition. These increases were achieved primarily by maintaining specific productivity throughout each fed-batch process. Improvements were seen immediately and without process optimization.
We have also shown that low-volume addition of FunctionMAX™ TiterEnhancer was sufficient to improve titers for several processes using different commercially available media and feeds, with those having higher cell densities seeing the most benefit. This additive is not designed to completely replace other feeding supplements that provide additional ingredients not found in FunctionMAX™ TiterEnhancer.
The technology used to deliver this functional additive promises to transform recombinant drug bioprocessing by raising key ingredient concentrations to levels that are out of reach using conventional approaches. A concentration of 150 g/L is achieved with FunctionMAX™ TiterEnhancer (compared to 20–25 g/L for most basal media), and it has been shown to be stable in dry or liquid format for over 1 year.
Reconstitution of the AGT™ dry format is surprisingly simple (add water and stir), with all components going into solution. There is no pH adjustment required, and being pH neutral it is safer in handling and use than extreme pH alternatives. As a pH neutral additive, this product will help avoid bioreactor complications often seen with extreme pH supplements. Further, the liquid is very stable—so much so that the liquid format version is made from the same AGT™ dry format material that is also available for purchase. The liquid is provided for small-scale trials and the AGT™ dry format for seamless scale-up in use.