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Recent developments in processing systems for cell and tissue cultures toward therapeutic application

Paper ID Volume ID Publish Year Pages File Format Full-Text
21685 43235 2009 10 PDF Available
Title
Recent developments in processing systems for cell and tissue cultures toward therapeutic application
Abstract

Innovative techniques of cell and tissue processing, based on tissue engineering, have been developed for therapeutic applications. Cell expansion and tissue reconstruction through ex vivo cultures are core processes used to produce engineered tissues with sufficient structural integrity and functionality. In manufacturing, strict management against contamination and human error is compelled due to direct use of un-sterilable products and the laboriousness of culture operations, respectively. Therefore, the development of processing systems for cell and tissue cultures is one of the critical issues for ensuring a stable process and quality of therapeutic products. However, the siting criterion of culture systems to date has not been made clear. This review article classifies some of the known processing systems into ‘sealed-chamber’ and ‘sealed-vessel’ culture systems based on the difference in their aseptic spaces, and describes the potential advantages of these systems and current states of culture systems, especially those established by Japanese companies. Moreover, on the basis of the guidelines for isolator systems used in aseptic processing for healthcare products, which are issued by the International Organization for Standardization, the siting criterion of the processing systems for cells and tissue cultures is discussed in perspective of manufacturing therapeutic products in consideration of the regulations according to the Good Manufacturing Practice.

Keywords
Biomedical engineering; Tissue engineering; Bioreactor design; Manufacturing of therapeutic products; Automation and process control; Quality assurance
First Page Preview
Recent developments in processing systems for cell and tissue cultures toward therapeutic application
Publisher
Database: Elsevier - ScienceDirect
Journal: Journal of Bioscience and Bioengineering - Volume 108, Issue 4, October 2009, Pages 267–276
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering