The manufacturing process of recombinant factor VIII, recombinate.
In summary, this brief report documents the cell culture and rAHF purification systems used to produce rFVIII and has focused on the unique characteristics of the cell line, the production process, and purification system used. This review emphasizes the general philosophy used throughout the research and development of this innovative and complex therapeutic agent, in order to provide a safe and efficacious rAHF in the management of individuals with hemophilia A. This review provides a brief description of the in-process system and controls that have been incorporated to meet the high standards and safety objective.
Gomperts
E
E
Baxter Healthcare, Hyland Division, Glendale, CA 91203.
Lundblad
R
R
Adamson
R
R
D000818:Animals; D016466:CHO Cells; D006224:Cricetinae; D005169:Factor VIII / Q000096:biosynthesis* / Q000235:genetics / Q000592:standards; D011786:Quality Control; D011994:Recombinant Proteins / Q000096:biosynthesis* / Q000235:genetics / Q000592:standards
D011994:Recombinant Proteins; D005169:Factor VIII