Research Catalog

Title

Guidance for industry : validation of growth-based rapid microbiological methods for sterility testing of cellular and gene therapy products.

Publication

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2008]

Details

Additional Authors

Center for Biologics Evaluation and Research (U.S.)

Description

i, 12 pages : digital, PDF file

Alternative Title

Validation of growth-based rapid microbiological methods for sterility testing of cellular and gene therapy products

Subject

• Cellular therapy > Testing
• Gene therapy > Testing
• Rapid methods (Microbiology)

Note

• Title from PDF title page (viewed on Apr. 28, 2009).
• "Draft guidance".
• "February 2008".
• Includes bibliographical references (p. 12).

System Details (note)

• Mode of access: Internet at the FDA CBER Web site. Address as of 4/28/09: http://connexion.oclc.org/WebZ/CorcSCAN?sessionid=cnxs04.prod.oclc.org-38204-fu2vwnqz-d2g4oh ; current access is available via PURL.

Call Number

GPO Internet HE 20.4802:R 18

OCLC

marcive319547905

Title

Guidance for industry : validation of growth-based rapid microbiological methods for sterility testing of cellular and gene therapy products.

Publisher

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2008]

Type of Content

text

Type of Medium

computer

Type of Carrier

online resource

System Details

Mode of access: Internet at the FDA CBER Web site. Address as of 4/28/09: http://connexion.oclc.org/WebZ/CorcSCAN?sessionid=cnxs04.prod.oclc.org-38204-fu2vwnqz-d2g4oh ; current access is available via PURL.

Connect to:

https://purl.fdlp.gov/GPO/LPS111982

Added Author

Center for Biologics Evaluation and Research (U.S.)

Gpo Item No.

0499-T-02 (online)

Sudoc No.

HE 20.4802:R 18