Dendritic cells for active immunotherapy: Optimizing design and manufacture in order to develop commercially and clinically viable products

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• 作者：C.A. Nicolette ; D. Healey ; I. Tcherepanova ; P. Whelton ; T. Monesmith ; L. Coombs ; L.H. Finke ; T. Whiteside ; F. Miesowicz
• 关键词：Human dendritic cells ; Cancer ; Production for therapy ; Regulatory requirements ; Quality control ; Active immunotherapy
• 刊名：Vaccine
• 出版年：2007
• 出版时间：27 September 2007
• 年：2007
• 卷：25
• 期：Supplement 2
• 页码：B47-B60
• 全文大小：354 K

文摘

Dendritic cell (DC) active immunotherapy is potentially efficacious in a broad array of malignant disease settings. However, challenges remain in optimizing DC-based therapy for maximum clinical efficacy within manufacturing processes that permit quality control and scale-up of consistent products. In this review we discuss the critical issues that must be addressed in order to optimize DC-based product design and manufacture, and highlight the DC based platforms currently addressing these issues. Variables in DC-based product design include the type of antigenic payload used, DC maturation steps and activation processes, and functional assays. Issues to consider in development include: (a) minimizing the invasiveness of patient biological material collection; (b) minimizing handling and manipulations of tissue at the clinical site; (c) centralized product manufacturing and standardized processing and capacity for commercial-scale production; (d) rapid product release turnaround time; (e) the ability to manufacture sufficient product from limited starting material; and (f) standardized release criteria for DC phenotype and function. Improvements in the design and manufacture of DC products have resulted in a handful of promising leads currently in clinical development.