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COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY PRODUCTS Ángel Herrero, PhD The seventh annual regulatory conference organised by EBE, 4 December 2018, London Session 3: Complexity of innovative manufacturing and the associated challenges for comparability

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Page 1: COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY PRODUCTS ÁngelHerrero, PhD The seventh annual regulatory conference

COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS

Ángel Herrero,PhD

TheseventhannualregulatoryconferenceorganisedbyEBE,4December2018,LondonSession3:Complexityofinnovativemanufacturingandtheassociatedchallengesforcomparability

Page 2: COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY PRODUCTS ÁngelHerrero, PhD The seventh annual regulatory conference

COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS

ALOFISEL

Page 3: COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY PRODUCTS ÁngelHerrero, PhD The seventh annual regulatory conference

COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS

§ Newrawmaterials:Startingmaterials

§ ChangesintheManufacturingprocess

§ Scale-up

§ Transfers

§ …

§ Changesintheanalyticalmethods

Evolvingfield

WHENCOMPARABILITYSTUDIESARENEEDED?

Page 4: COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY PRODUCTS ÁngelHerrero, PhD The seventh annual regulatory conference

COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS

§ Newrawmaterials:Mediaofknowncomposition

§ ChangesintheManufacturingprocess:Bioreactors

§ Changesintheanalyticalmethods:Nextgenerationsequencing

WHENCOMPARABILITYSTUDIESARENEEDED?

Page 5: COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY PRODUCTS ÁngelHerrero, PhD The seventh annual regulatory conference

COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS

RISKASSESSMENT

CHANGEIDENTIFIED

ACTIONPLANFORIMPLEMENTATION

COMPARABILITY………

Page 6: COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY PRODUCTS ÁngelHerrero, PhD The seventh annual regulatory conference

COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS

RISKASSESMENTELEMENTS

Experiencegainedduringproductlife

cycle

AffectedstepsoftheManufacturing

process

ImpactofthechangeintheCQA

Protectionofthepatient

Page 7: COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY PRODUCTS ÁngelHerrero, PhD The seventh annual regulatory conference

ClinicaltrialInvivostudies

StabilityTesting

ExtendedCharacterisation

InProcessControls

ReleaseTesting

COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS

Referencematerial?

RISKASSESMENTANALYSES

Page 8: COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY PRODUCTS ÁngelHerrero, PhD The seventh annual regulatory conference

COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS

INTRODUCTIONOFNEWDONATIONS

§ Enoughexperience

§ Updateoftheprotocols

§ Acceptancecriteria

Page 9: COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY PRODUCTS ÁngelHerrero, PhD The seventh annual regulatory conference

COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS

INTRODUCTIONOFNEWDONATIONS

ExperienceDonor

variability

Page 10: COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY PRODUCTS ÁngelHerrero, PhD The seventh annual regulatory conference

COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS

INTRODUCTIONOFNEWDONATIONS

Lowyield

ReleasecriteriaIPCs

Page 11: COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY PRODUCTS ÁngelHerrero, PhD The seventh annual regulatory conference

COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS

Howtoperformacceleratedstabilitytests?

Cancompaniesupdatetheseestablishedcomparabilityprotocolswhengainingexperience?

Howtoestablishabalancewiththeexperienceandthepotentialvariabilityofthedonors?

Arecurrentlyreferencestandardsforcelltherapyproductstobeusedincomparabilitystudies?

Shouldextendedcharacterisation testsneedtobevalidatedinthesamewayasthereleasetestsor

shouldtheysimplybequalified?

Page 12: COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY ...€¦ · COMPARABILITY CHALLENGES FOR ALLOGENEIC CELL THERAPY PRODUCTS ÁngelHerrero, PhD The seventh annual regulatory conference

COMPARABILITYCHALLENGESFORALLOGENEICCELLTHERAPYPRODUCTS

Manythanksforyourattention

For any question please [email protected]

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