PDA TR82 低内毒素回收率Low Endotoxin Recovery-英文-2019.pdf

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