Manufacturing 

Agennix manufactures talactoferrin through fermentation in Aspergillus. Working with DSM N.V., the talactoferrin manufacturing process has been scaled up to 35,000 liters, a scale sufficient to supply Phase III trials and commercial launch. Capacity can be added rapidly by using additional 35,000 liter fermenters that are available at the same site.

Agennix believes that successful scale-up and Agennix's alliance with an experienced biologics manufacturer have reduced the developmental and regulatory risks that can slow the approval and supply of biologics. The manufacturing facility already has produced commercial product for other companies and has been inspected by the FDA and the EMEA, simplifying the pre-approval inspection process.


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