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City Seattle / / Company Dendreon / Sipuleucel-T (Provenge®) Dendreon Corporation / / Event FDA Phase / / Facility New Jersey facility / / IndustryTerm manufacturing scale product / a lot of product / manufacturing facility / manufacturing data / actual manufacturing specifications / final product / manufacturing procedure / protein product / unpotent product / manufacturing experience / data showing that product / manufacturing protocol / infusion site / manufacturing stages / patient product / tight manufacturing schedule / manufacturing sites / manufacturing / manufacturing site / clinical manufacturing experience / detection algorithms / treatment of hormone refractory prostate cancer / apheresis product / clinical product / product manufacturing / manufacturing process / identical manufacturing process / / MedicalCondition tumor / alternate sterility / sterility / alternative sterility / refractory prostate cancer / prostate cancer / kill cancer / / MedicalTreatment leukapheresis / apheresis / vaccination / / Organization Cell and Gene Therapies office of Cellular / Tissue / and Gene Therapies Reviewed / / Person Malcolm Moos / Thomas Finn / Keith Wonnacott / Syed Husain / Lot Release / Raj Puri / Kimberly Benton / Gene Therapies / / Position Director / Division / Director / Deputy Division / EXECUTIVE / representative / General / Deputy Division Director / Director Division / / Product CD54 / PA2024 / / ProvinceOrState New Jersey / / Technology 91 3.2.S.7.2 Post-Approval Stability Protocol / 266 3.2.P.8.2 POST APPROVAL STABILITY PROTOCOL / detection algorithms / manufacturing protocol / 267 3.2.R.2 Comparability Protocols / /
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CMC REVIEW BLA[removed]Sipuleucel-T (Provenge®) Dendreon Corporation