Pharmacia & Upjohn AB / Indication Factor (Recombinant) & Upjohn AB / Genetics Institute Inc. / The Master Cell Bank / Implementation of US / Working Cell Bank / Controls A. Manufacturing / /
Continent
Europe / /
Country
United States / Sweden / / /
Event
FDA Phase / /
Facility
Pharmacia & Upjohn AB facility / /
IndustryTerm
final drug product / final product / drug product / manufacturing practices / biological product / manufacturing sites / cell culture manufacturing process / manufacturing / cell banking / light-sensitive product / clinical site / treatment of hemophilia / manufacturing process / /
MedicalCondition
hemophilia A / hemostatic deficiency / acquired hemophilia syndrome / sterility / Bovine Spongeform Encephalopathy / VIII deficiency / von Willebrand’s disease / classic hemophilia / severe hemophilia A / /
MedicalTreatment
intravenous infusion / /
Organization
International Unit / World Health Organization / office of Regulatory Affairs / WCB / International Society on Thrombosis and Hemostasis / FDA / U.S. Securities and Exchange Commission / Center for Biologics Evaluation and Research / Genetics Institute / /
Antihemophilic Factor (Recombinant) ReFacto