Manufacturing and Purification

Complex protein production

Established cell line shown to be free of foreign agents and capable of producing large amounts of rFIX in an albumin-free medium2,3,†

 

Advanced purification

Customized purification processes designed with viral safety in mind2,3

 

Quality validation

Over 150 quality control examinations are performed on each batch of BeneFix to help ensure a consistent purification process4

 

A history of sustained supply—more than 10 billion IU of product manufactured5

Chinese hamster ovary (CHO) cells used to manufacture BeneFix are grown in media containing no added human or animal components.6