PDA TR89 疫苗开发和生命周期管理策略.pdf

PDA

ParenteralDr畔Association

萝

TechnicalReportNo.89

StrategiesforVaccineDevelopmentandLifecycle

Management

StrategiesforVaccineDevelopmentandLifecycleManagement

AuthorsandContributors

SabrinaRestrepo,PhD,MerckCo.LyneLePalaire,SanofiPasteur

(Co-Chair)MicMcGoldrick,MerckCo.

JaneHalpern,PhD,IAVI(Co-Chair)PriyabrataPattnaik,PhD,Indianlmmuno-

MihaiBilanin,PhD,GSKVaccineslogicalsLimited

CristianaCampa,PhD,GSKVaccinesRichardPelt,PfizerInc.

ClariceHutchens,PhD,PfizerInc.JonShantee,MerckCo.

MaheshKrishnan,PhD,MerckCo.

StrategiesforVaccine

DevelopmentandLifecycle

Management

TechnicalReportNo.89

ISBN:978-1-945584-37-4

©2023ParenteralDrugAssociation,Inc.

Allrightsreserved.

翌

TableofContents

1.0INTRODUCTION15.2ChallengesofUsingComparabilityAssessments

1.1Pu『pose2forVaccines13

1.2Scope35.3RecommendedConsiderationsforCompa『ability

ProtocolsandComparabilityAssessmentsfor

2.0ABBREVIATIONS4Vaccines14

5.4SuggestedBestP『acticesfo『Compa『ability

3.0EXISTINGGUIDANCEDOCUMENTSFORVACCINES...4Assessments16

4.0CONTROLSTRATEGYFROMPROCESS6.0CONSIDERATIONSFORVACCINESLIFECYCLE

DEVELOPMENTTOVACCINELIFECYCLEMANAGEMENT19

MANAGEMENT…6