COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR...

COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS

Ángel Herrero,PhD

TheseventhannualregulatoryconferenceorganisedbyEBE,4December2018,LondonSession3:Complexityofinnovativemanufacturingandtheassociatedchallengesforcomparability

ALOFISEL

§ Newrawmaterials:Startingmaterials

§ ChangesintheManufacturingprocess

§ Scale-up

§ Transfers

§ …

§ Changesintheanalyticalmethods

Evolvingfield

WHENCOMPARABILITYSTUDIESARENEEDED?

§ Newrawmaterials:Mediaofknowncomposition

§ ChangesintheManufacturingprocess:Bioreactors

§ Changesintheanalyticalmethods:Nextgenerationsequencing

WHENCOMPARABILITYSTUDIESARENEEDED?

RISKASSESSMENT

CHANGEIDENTIFIED

ACTIONPLANFORIMPLEMENTATION

COMPARABILITY………

RISKASSESMENTELEMENTS

Experiencegainedduringproductlife

AffectedstepsoftheManufacturing

process

ImpactofthechangeintheCQA

Protectionofthepatient

ClinicaltrialInvivostudies

StabilityTesting

ExtendedCharacterisation

InProcessControls

ReleaseTesting

Referencematerial?

RISKASSESMENTANALYSES

INTRODUCTIONOFNEWDONATIONS

§ Enoughexperience

§ Updateoftheprotocols

§ Acceptancecriteria

ExperienceDonor

variability

Lowyield

ReleasecriteriaIPCs

Howtoperformacceleratedstabilitytests?

Cancompaniesupdatetheseestablishedcomparabilityprotocolswhengainingexperience?

Howtoestablishabalancewiththeexperienceandthepotentialvariabilityofthedonors?

Arecurrentlyreferencestandardsforcelltherapyproductstobeusedincomparabilitystudies?

Shouldextendedcharacterisation testsneedtobevalidatedinthesamewayasthereleasetestsor

shouldtheysimplybequalified?

Manythanksforyourattention

For any question please contactangel.herrero@Takeda.com

COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR...

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