FunctionMAX™ TiterEnhancer, AGT™ additive

Description

FunctionMAX™ TiterEnhancer uses a new technology to combine key nutrients in a highly concentrated (150 g/L), pH-neutral, chemically-defined, AOF (animal origin-free) functional additive that is designed to reinforce existing feeds and amplify the productivity of standard high cell density fed-batch platforms. FunctionMAX™ TiterEnhancer is available in both a liquid format and this AGT™ dry format and is stable for over 1 year. FunctionMAX™ TiterEnhancer offers:

• Up to double prior fed-batch titers
• Highly concentrated ingredients
• Easy to use pH-neutral format
• Specialized delivery of ingredients found in base media—nothing exotic
• Use that is economical

When to Choose FunctionMAX™ TiterEnhancer:

• If you have a drop off in specific productivity late in a high density fed-batch culture, FunctionMAX™ TiterEnhancer may be able to improve your titers
• If you have an extremely low peak cell density fed-batch culture, you may want to consult with PD-Direct® Services for advice on cell adaptation and/or fed-batch optimization
• If you have no drop off in specific productivity late in a high density fed-batch culture and still need higher titers, you may want to consult with PD-Direct® Services for advice on fed-batch optimization

Up to Double Prior Fed-batch Titers
We have demonstrated 35–120% product titer improvements when FunctionMAX™ TiterEnhancer was added on top of existing processes or as a partial feed replacement (Figures 1–3), 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.

Highly Concentrated Ingredients
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.

Easy-to-Use pH-neutral Format
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.

Specialized Delivery of Ingredients Found in Base Media—Nothing Exotic
FunctionMAX™ TiterEnhancer does not introduce new ingredients to your fed-batch process; it simply provides the same key ingredients found in basal media that the cells need late in culture to maintain their productivity. Further, the technology used to combine these ingredients does not introduce any additional ingredients. Nor does it contain any growth factors or undefined components like hydrolysates. A DMF (drug master file) reference can be requested for this product for assurance of regulatory authorities that there are no substances or ingredients in the formulation that might create regulatory concerns.

Economies in Use
FunctionMAX™ TiterEnhancer is designed to deliver highly concentrated and high value addition to your fed-batch process. Consider that it provides 7-fold the ingredient concentration of a basal medium and can provide up to a doubling of titer. Further, in normal use at about 10% of working volume, the actual price per liter of use is similar to that of basal media.

Figures

Specifications

Form:	Powder (AGT)
Cell Line:	CHO
Glutamine:	No Glutamine
Sterility:	Nonsterile
Serum Level:	Serum-Free
Product Size:	10 L
Classification:	Animal Origin-Free, Protein-Free, Chemically Defined
Shipping Condition:	Wet Ice

Contents & storage