Research ArticleConference Proceeding
Root Cause Investigation of Unusual Results Experienced during Master Cell Bank (MCB) Testing and Characterization
Dayue Chen and Christopher C. Hatfield
PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 465-470;
Dayue Chen
Christopher C. Hatfield

References
- 1.↵
- Chen D.,
- Nims R.,
- Dusing S.,
- Miller P.,
- Luo W.,
- Quertinmont M.,
- Parekh B.,
- Poorbaugh J.,
- Boose J. A.,
- Atkinson E. M.
- 2.↵
Points to consider in the characterization of cell lines used to produce biologicals. Center for Biologics Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services, 1993.
- 3.↵
Points to consider in the manufacture and testing of monoclonal antibody production for human use. Center for Biologics Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services, 1997.
- 4.↵
Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Q5A, 1998.
- 5.↵
Derivation and characterization of cell substrates used for production of biotechnological/biological products. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Q5D, 1997.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 5
September/October 2010
Root Cause Investigation of Unusual Results Experienced during Master Cell Bank (MCB) Testing and Characterization
Dayue Chen, Christopher C. Hatfield
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 465-470;
Jump to section
Related Articles
- No related articles found.
Cited By...
- No citing articles found.