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TechnicalReportNo.82
LowEndotoxinRecovery
PDALowEndotoxinRecoveryTechnicalReportTeam
DayueChen,PhD,EliLillyandCompany,Co-leader
FriedrichvonWintzingerode,PhD,Genentech,AMemberoftheRocheGroup,Co-leader
JulieBarlasov-Brown,MerckCo.
LindseyBrown,PhD,U.S.FoodandDrugAdministration
AllenBurgenson,LonzaGroupLtd.
JosephChen,PhD,UltragenixPharmaceutical,Inc.
MonicaCommerford,PhD,U.S.FoodandDrugAdministration
GregoryDevulder,PhD,bioMerieux,Inc.
JenniferFarrington,PhD,AssociatesofCapeCod,Inc.
JessicaHankins,PhD,U.S.FoodandDrugAdministration
PatriciaHughes,PhD,U.S.FoodandDrugAdministration
StefanIshak,Novartis
ChrisKnutsen,PhD,Bristol-MyersSquibbInc.
JackLevin,MD,UniversityofCalifornia,SanFrancisco,SchoolofMedicine
JeanneMateffy,AmgenInc.
NedMozier,PhD,PfizerInc.
ScottNichols,PhD,U.S.FoodandDrugAdministration
CherylPlatco,MerckCo.(retired)
JohannesReich,PhD,MicrocoatBiotechnologieGmbH
StijnSeels,Sanofi
AndersThorn,NovoNordiskA/S
MasakazuTsuchiya,PhD,CharlesRiverLaboratories,Inc.
RenéØrving,Biogen
Foreword
PDAisatitsheartascience-basedorganization.Ouractivitiesandprocesseshavebeenimplemented
topromotethefreeexchangeofideasandpromoteinclusioninparticipation,regardlessoftheorgani-
zationtowhichamembermaybelong.Wealsostrivetoachieveconsensusamongthesubjectmatter
expertsandtoinformourmembers(andothers)ofthebestpractice(andinsomecases,theregulatory
requirements).Ouraimisalwaystomakerecommendationsthatadvancepatientsafety.
PDAhasalsoimplementedamultistagereviewprocessfortechnicalreportsandpositionpapers,
whichincludesnotonlythetaskforceitselfandtherelevantadvisoryboard,butalsopeerreviewers
whoofferindependentinputonthesubjectmatter.Finally,ofcour
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