Quality control and batch release aspects of Advanced Therapy Medicinal Products
Julie Veran
(1)
,
Michael Morrison
(2)
,
Florence Sabatier
(3)
,
Léa Chey
(4)
,
Fatou Mbodj
(4)
,
Éloïse Gennet
(5)
,
Véronique Andrieu
(6)
,
Aurélie Mahalatchimy
(5)
1
APHM -
Assistance Publique - Hôpitaux de Marseille
2 HeLEX - Centre for Health, Law and Emerging Technologies
3 C2VN - Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research
4 AMU - Aix Marseille Université
5 DICE / CERIC - Droits International, Comparé et Européen / Centre d'études et de recherches internationales et communautaires (CERIC)
6 MEPHI - Microbes évolution phylogénie et infections
2 HeLEX - Centre for Health, Law and Emerging Technologies
3 C2VN - Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research
4 AMU - Aix Marseille Université
5 DICE / CERIC - Droits International, Comparé et Européen / Centre d'études et de recherches internationales et communautaires (CERIC)
6 MEPHI - Microbes évolution phylogénie et infections
Florence Sabatier
- Fonction : Auteur
- PersonId : 958995
Éloïse Gennet
- Fonction : Auteur
- PersonId : 999043
- IdRef : 234643447
Aurélie Mahalatchimy
- Fonction : Auteur
- PersonId : 18844
- IdHAL : aurelie-mahalatchimy
- ORCID : 0000-0002-4365-2143
- IdRef : 172268745
Résumé
Quality control and batch release raise specific challenges for ensuring quality and complying with regulatory requirements in order to obtain manufacturing and marketing authorizations for Advanced Therapy Medicinal Products (ATMPs). ATMPs are medicinal products based on genes, cells and tissues that have been specifically regulated in the European Union (EU) from 2007. In the guidelines on Good Manufacturing Practices (GMP) specific to ATMPs from the European Commission, specific requirements cover quality control and batch release. They are distinct from the ones than can be found in other guidelines on GMP applicable to other kinds of biological medicinal products. Through a comparative textual analysis of the GMP guidelines for biological medicinal products and ATMPs, this poster will highlight the key areas of similarities and differences. Our analysis mainly focuses on qualification and validation procedures, batch release process, quality defects and product recalls, and automated production of ATMPs. This analysis reveals why we have two different texts and whether they are based on substantial differences regarding quality control and batch release between ATMPs and other types of biological medicinal products.
Format du dépôt | Fichier |
---|---|
Type de dépôt | Poster de conférence |
Titre |
en
Quality control and batch release aspects of Advanced Therapy Medicinal Products
|
Résumé |
en
Quality control and batch release raise specific challenges for ensuring quality and complying with regulatory requirements in order to obtain manufacturing and marketing authorizations for Advanced Therapy Medicinal Products (ATMPs). ATMPs are medicinal products based on genes, cells and tissues that have been specifically regulated in the European Union (EU) from 2007. In the guidelines on Good Manufacturing Practices (GMP) specific to ATMPs from the European Commission, specific requirements cover quality control and batch release. They are distinct from the ones than can be found in other guidelines on GMP applicable to other kinds of biological medicinal products. Through a comparative textual analysis of the GMP guidelines for biological medicinal products and ATMPs, this poster will highlight the key areas of similarities and differences. Our analysis mainly focuses on qualification and validation procedures, batch release process, quality defects and product recalls, and automated production of ATMPs. This analysis reveals why we have two different texts and whether they are based on substantial differences regarding quality control and batch release between ATMPs and other types of biological medicinal products.
|
Auteur(s) |
Julie Veran
1
, Michael Morrison
2
, Florence Sabatier
3
, Léa Chey
4
, Fatou Mbodj
4
, Éloïse Gennet
5
, Véronique Andrieu
6
, Aurélie Mahalatchimy
5
1
APHM -
Assistance Publique - Hôpitaux de Marseille
( 300073 )
- Direction générale AP-HM
80, rue Brochier
13 354 Marseille Cedex 5
- France
2
HeLEX -
Centre for Health, Law and Emerging Technologies
( 567410 )
- Royaume-Uni
3
C2VN -
Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research
( 1002339 )
- Faculté de Médecine de la Timone 27 boulevard Jean Moulin 13385 MARSEILLE CEDEX 5
- France
4
AMU -
Aix Marseille Université
( 198056 )
- Aix-Marseille Université
Jardins du Pharo
58 Boulevard Charles Livon
13284 Marseille cedex 7
- France
5
DICE / CERIC -
Droits International, Comparé et Européen / Centre d'études et de recherches internationales et communautaires (CERIC)
( 199942 )
- Espace Cassin, 3 Av Robert Schuman 13628 AIX EN PROVENCE CEDEX 1
- France
6
MEPHI -
Microbes évolution phylogénie et infections
( 527038 )
- IHU Méditerranée Infection
19-21 Bd Jean Moulin
13005 Marseille
- France
|
Langue du document |
Anglais
|
Vulgarisation |
Non
|
Comité de lecture |
Oui
|
Invité |
Non
|
Audience |
Internationale
|
Actes |
Non
|
Ville |
Ghent
|
Pays |
Belgique
|
Public visé |
Scientifique
|
Titre du congrès |
Annual Conference of the European Association of Health Law (8th EAHL-Conference)
|
Date début congrès |
2022-04-21
|
Domaine(s) |
|
Projet(s) ANR |
|
Origine :
Fichiers produits par l'(les) auteur(s)
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