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Advances in Cell-based Therapeutic Process Development

Gretzinger, Sarah

Abstract (englisch):
The prospect of substituting damaged or diseased tissue by cell-based therapeutics has created much excitement in the last decades, since cell-based therapeutics open up new possibilities in patient treatment towards regenerative medicine. However, the first generation of cell-based therapeutics could not live up to market expectations and some were even withdrawn due to low reimbursement levels. While these products might be considered as market failures, identifying the obstacles early cell-based products were facing represents a major opportunity to improve the market performance of future products. In general, the inherent complexity of cell-based products in combination with limited experience represents a major obstacle translating a possible candidate from bench to bedside. A deeper insight was gained by the retrospective evaluation of the translational challenges where they could be further classified in three categories: (1) pre-market challenges, (2) manufacturing challenges and (3) post-market challenges.
A fundamental step towards commercialization is the process development (industrial scale and grade) which affects all three translational challenge categories. ... mehr

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Volltext §
DOI: 10.5445/IR/1000105111
Veröffentlicht am 22.01.2020
Cover der Publikation
Zugehörige Institution(en) am KIT Institut für Funktionelle Grenzflächen (IFG)
Publikationstyp Hochschulschrift
Publikationsjahr 2020
Sprache Englisch
Identifikator KITopen-ID: 1000105111
Verlag Karlsruhe
Umfang 198 S.
Abschlussart Dissertation
Fakultät Fakultät für Chemieingenieurwesen und Verfahrenstechnik (CIW)
Institut Institut für Funktionelle Grenzflächen (IFG)
Prüfungsdatum 15.03.2019
Referent/Betreuer Prof. J. Hubbuch
KIT – Die Forschungsuniversität in der Helmholtz-Gemeinschaft
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