Manufacturing Clinical-Grade Cell and Gene Therapy Products: Economic Implications for Academic GMP Facilities - Couverture souple

Abou-El-Enein, Mohamed

Couverture souple

ISBN 10 : 3838138651 ISBN 13 : 9783838138657

Editeur : Südwestdeutscher Verlag für Hochschulschriften, 2014

Synopsis

Advanced therapy medicinal products (ATMP) represents a new class of medicinal products, which include - amongst others - somatic cell and gene therapies. As the final product is intended for administration into humans, manufacturers of ATMPs are obligated to apply good manufacturing practice (GMP) standards within their processes. Reaching and maintaining such standards is cost intensive and requires sophisticated manufacturing facilities. As a result, academic researchers who are developing these novel therapeutic approaches are facing new technological and financial challenges. In order to bring more commercially accessible therapies to patients and demonstrate efficient manufacturing technologies, we established the clean-room technology assessment technique (CTAT). CTAT comprises several tools to identify and assign a reliable monetary value to the different operational processes. The model also serves as a guideline for optimizing the operation of an academic GMP facility.

A propos du livre

À propos de l'auteur

The acting head of the Clinical Development Unit at the Berlin Center for Regenerative Therapies since 2013. Dr. Abou-El-Enein received his doctorate in Health Economics at the Charité University and his MSc in Biopharmaceutical Regulations at University of Strasbourg. He obtained further training in Clinical Research at Harvard Medical School.

Détails de l'édition

• Éditeur: Südwestdeutscher Verlag für Hochschulschriften
• Date d'édition: 2014
• Langue: anglais
• ISBN 10: 3838138651
• ISBN 13: 9783838138657
• Reliure: Broché
• Nombre de pages: 80
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible