rubber stoppers / final drug product / protein product / manufacturing pool / end product / reconstitution device / rubber stopper / transfer device / manufacturing process / needless transfer device / final product / manufacturing procedure / individual processing steps / opalescent solution / manufacturing steps / manufacturing / manufacturing site / carrier molecules / final bulk solution / /
MedicalCondition
HIV / XIII deficiency / HBV / sterility / herpes / hepatitis B / Hemophilia A / HCV / bovine viral diarrhea virus / /
MedicalTreatment
plasmapheresis / /
Movie
Half-life / /
MusicGroup
Yes / /
Organization
CBER office of Compliance and Biologics Quality / Division of Case Management / CorifactTM administration / Approval Jay S. Epstein____________________________ Offices Signatory Authority / FDA / Signatory Authority / European Union / /
Person
John Eltermann / Tim Lee / Alan C. Ou / Jay S. Epstein / Michael Brony / Mahmood Epidemiology Alan / Renee Rees Pharmacology / Daniela J. Vanco / Nisha Jain / /
Position
General / Chair / Committee / /
Product
Sodium chloride / Factor XIII / Sterile Water for Injection / CorifactTM / Factor XIII Concentrate / /
Region
West Nile / /
Technology
antibodies / process control / pharmacokinetics / Ion exchange / /