Design and operation of a current good manufacturing practices cell-engineering laboratory

Medical centers and biotechnology companies active in cellular and gene therapy increasingly are working to design and build clinical laboratories capable of performing cellular engineering and vector production using current good manufacturing practices (cGMPs). Because cell engineering is a rapidl...

Full description

Saved in:
Bibliographic Details
Published inCytotherapy (Oxford, England) Vol. 2; no. 2; pp. 111 - 122
Main Author Burger, Scott R.
Format Journal Article
LanguageEnglish
Published England Elsevier Inc 01.02.2000
Informa UK Ltd
Subjects
Biological Products - standards
Biotechnology - standards
Calibration
Drug Monitoring
Facility Design and Construction - standards
Quality Control
Sanitation
Online AccessGet full text

Cover

More Information
Summary:Medical centers and biotechnology companies active in cellular and gene therapy increasingly are working to design and build clinical laboratories capable of performing cellular engineering and vector production using current good manufacturing practices (cGMPs). Because cell engineering is a rapidly changing field, and definitions for cell engineering cGMPs are still being established, a cGMP cell-engineering laboratory most often should be designed with a broad range of potential applications in mind. While the laboratory facility is the most tangible aspect of cGMP, it represents only part of a larger process, which it must be designed and built to support.
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-1
content type line 23
ObjectType-Article-1
ObjectType-Feature-2
ISSN:1465-3249
1477-2566
DOI:10.1080/146532400539116