Microbial detection in mammalian cell culture systems

American Pharmaceutical Review

Volumn 10, Issue 1, 2007, Pages 24-29

  McDaniel, Amy ^a  

^a Wyeth Biotech

Author keywords

[No Author keywords available]

Indexed keywords

ANIMAL CELL; BACTERIUM CONTAMINATION; BACTERIUM DETECTION; CELL CULTURE MONITORING; CHO CELL; CONTROLLED STUDY; INTERMETHOD COMPARISON; LASER SCANNING CYTOMETRY; MEMBRANE FILTER; NONHUMAN; REACTOR MONITORING; SHORT SURVEY;

EID: 55549143015     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (4)

1. Chapter 〈1225〉,Validation of Compendial Methods, U.S. Pharmacopeia, USP 27, United States Pharmacopoeial Convention, Inc. Rockville,MD. 2005.
2. ICH Q2A. International Conference on Harmonization; Guideline on Validation of Analytical Procedures: Definitions and Terminology. Federal Register, 1995. Vol 60:40.
3. ICH Q2B. International Conference on Harmonization; Guideline on Validation of Analytical Procedures: Methodology. Federal Register, 1995. Vol 62:96.
4. Technical Report No. 33, Evaluation, Validation and Implementation of New Microbiological Testing Methods. PDA Journal of Pharmaceutical Science and Technology, supplement TR33, vol. 54, no. 3 (2000)