Compliance with Good Manufacturing Practices for facilities engaged in vector production, cell isolation, and genetic manipulations

Current Opinion in Biotechnology

Volumn 10, Issue 3, 1999, Pages 295-297

  Steel, Michael P ^a   Roessler, Blake J ^a  

^a UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY; CELL ISOLATION; CLONING VECTOR; GENETICS; GOOD MANUFACTURING PRACTICE; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; SHORT SURVEY;

EID: 0033152384     PISSN: 09581669     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0958-1669(99)80052-4     Document Type: Review

References (2)

1. US Government: Code of Federal Regulations, Sections 210, 211, and 600 of Title 21. Washington, DC: US Government Printing Office; 1998.
2. US Department of Health and Human Services, Center for Biologies Evaluation and Research, Food and Drug Administration: Guidance for human somatic cell therapy and gene therapy. Hum Gene Ther 1998, 9:1513-1524.