Towards Automated Manufacturing for Cell Therapies.
Curr Hematol Malig Rep
; 14(4): 278-285, 2019 08.
Article
em En
| MEDLINE
| ID: mdl-31254154
ABSTRACT
PURPOSE OF REVIEW Many cell therapy products are beginning to reach the commercial finish line and a rapidly escalating pipeline of products are in clinical development. The need to develop manufacturing capability that will support a successful commercial business model has become a top priority as many cell therapy developers look to secure long-term visions to enable both funding and treatment success. RECENT FINDINGS:
Manufacturing automation is both highly compelling and very challenging at the same time as a key tactic to address quality, cost of goods, scale, and sustainability that are fundamental drivers for commercially viable manufacturing. This paper presents an overview and strategic drivers for application of automation to cell therapy manufacturing. It also explores unique automation considerations for patient-specific cell therapy (PSCT) where each full-scale lot is for one patient vs off-the-shelf cell therapy (OTSCT) where a full-scale lot will treat many patients, and finally some practical considerations for implementing automation.Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Automação
/
Engenharia Genética
/
Engenharia Celular
/
Terapia Baseada em Transplante de Células e Tecidos
Tipo de estudo:
Prognostic_studies
Limite:
Animals
/
Humans
Idioma:
En
Revista:
Curr Hematol Malig Rep
Assunto da revista:
HEMATOLOGIA
/
NEOPLASIAS
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Estados Unidos