Challenge of cmc regulatory compliance for biopharmaceuticals, the
Auteur :
Geigert, John
Éditeur :
Springer International Publishing AG
ISBN :
9783031319112
Date de publication :
16 juin 2024
Dimensions :
23,5 x 15,5 cm
Langue :
Anglais
Pays d'origine :
Suisse
In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.