COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR...
Transcript of COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR...
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COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS
Ángel Herrero,PhD
TheseventhannualregulatoryconferenceorganisedbyEBE,4December2018,LondonSession3:Complexityofinnovativemanufacturingandtheassociatedchallengesforcomparability
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COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS
ALOFISEL
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COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS
§ Newrawmaterials:Startingmaterials
§ ChangesintheManufacturingprocess
§ Scale-up
§ Transfers
§ …
§ Changesintheanalyticalmethods
Evolvingfield
WHENCOMPARABILITYSTUDIESARENEEDED?
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COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS
§ Newrawmaterials:Mediaofknowncomposition
§ ChangesintheManufacturingprocess:Bioreactors
§ Changesintheanalyticalmethods:Nextgenerationsequencing
WHENCOMPARABILITYSTUDIESARENEEDED?
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COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS
RISKASSESSMENT
CHANGEIDENTIFIED
ACTIONPLANFORIMPLEMENTATION
COMPARABILITY………
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COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS
RISKASSESMENTELEMENTS
Experiencegainedduringproductlife
cycle
AffectedstepsoftheManufacturing
process
ImpactofthechangeintheCQA
Protectionofthepatient
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ClinicaltrialInvivostudies
StabilityTesting
ExtendedCharacterisation
InProcessControls
ReleaseTesting
COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS
Referencematerial?
RISKASSESMENTANALYSES
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COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS
INTRODUCTIONOFNEWDONATIONS
§ Enoughexperience
§ Updateoftheprotocols
§ Acceptancecriteria
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COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS
INTRODUCTIONOFNEWDONATIONS
ExperienceDonor
variability
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COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS
INTRODUCTIONOFNEWDONATIONS
Lowyield
ReleasecriteriaIPCs
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COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS
Howtoperformacceleratedstabilitytests?
Cancompaniesupdatetheseestablishedcomparabilityprotocolswhengainingexperience?
Howtoestablishabalancewiththeexperienceandthepotentialvariabilityofthedonors?
Arecurrentlyreferencestandardsforcelltherapyproductstobeusedincomparabilitystudies?
Shouldextendedcharacterisation testsneedtobevalidatedinthesamewayasthereleasetestsor
shouldtheysimplybequalified?
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COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS
Manythanksforyourattention
For any question please [email protected]