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—over 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