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Biotechnology / Enzymes / Galactosides / Alpha-galactosidase / Fabry disease / Vector / Chinese hamster ovary cell / Recombinant DNA / Globotriaosylceramide / Biology / Molecular biology / Cell lines


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration CBER, OTRR
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Company

Cell Bank The / Manufacturers Working Cell Bank / Genzyme Corporation / Post Production Cell Bank / Master Cell Bank / /

Event

Product Release / /

IndustryTerm

Treatment of Fabry’s Disease / treatment of Fabry disease / authorized manufacturing personnel / bank / peripheral and autonomic nervous systems / ndependent contractor / bank system / manufacturing areas / manufacturing / /

MedicalCondition

angiokeratomas / genetically inheritable disease / genetic disorder / Fabry’s Disease / pain / Fabry disease / disorder / /

MedicalTreatment

enzyme replacement therapy / intravenous infusion / /

Organization

EPC / Food and Drug Administration / OTRR Division of Therapeutic Proteins / WCB / DEPARTMENT OF HEALTH / /

Person

Gene Construct / Barry W. Cherney / Blair A. Fraser / John C. Hill / /

/

Position

contractor / /

Product

CMC-Product Review I. / Fabrazyme / Review I. / /

Technology

alpha / electrophoresis / Cloning / Recombinant DNA / /

SocialTag