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Peripheral membrane proteins / IDEC / Sterilization / Recombinant DNA / Factor IX / Haemophilia / Validation / Biology / Coagulation system / Biogen Idec


DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Center for Biologics Evaluation and Research Office of Compliance and Biologics Quality Division of Manufacturing and Product Quality
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Company

Biogen Idec Inc. / REVIEW SUMMARY Biogen Idec Inc. / 59 Biogen Idec Inc. / OCBQ/DMPQ / /

Event

FDA Phase / Reorganization / /

Facility

Biogen Idec facility / /

IndustryTerm

recombinant product / validation protocols / process validation protocols / treatment of hemophilia / reconstituted drug product / worst case equipment / manufacturing process / /

Organization

Compliance and Biologics Quality Division of Manufacturing / FDA / Biologics Evaluation and Research office of Compliance / HUMAN SERVICES Food and Drug Administration Center / DEPARTMENT OF HEALTH / /

Person

Nancy Kirschbaum / Ellen Huang / Marion Michaelis / /

Position

Director / OCBQ/DMPQ / Chair / Branch Chief / /

Product

HFM-380 / PPD-003246 / ALPROLIX™ / /

Technology

heat transfer / validation protocols / Recombinant DNA / /

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