Research ArticleConference Proceeding
Regulatory Considerations for Raw Materials Used in Biological Products
A. S. Khan
PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 451-457;
A. S. Khan

References
- 1.↵
- 2.↵
- 3.↵
- Robertson J. S.,
- Nicolson C.,
- Riley A. M.,
- Bentley M.,
- Dunn G.,
- Corcoran T.,
- Schild G. C.,
- Minor P.
- 4.↵
- Tsang S. X.,
- Switzer W. M.,
- Shanmugam V.,
- Johnson J. A.,
- Goldsmith C.,
- Wright A.,
- Fadly A.,
- Thea D.,
- Jaffe H.,
- Folks T. M.,
- Heneine W.
- 5.↵
- Weissmahr R. N.,
- Schupbach J.,
- Boni J.
- 6.↵
- Waters T. D.,
- Anderson P. S. Jr..,
- Beebe G. W.,
- Miller R. W.
- 7.↵
- Melnick J. L.,
- Stinebaugh S.
- 8.↵
- Sweet B. H.,
- Hilleman M. R.
- 9.↵
- Li T.-C.,
- Scotti P. D.,
- Miyamura T.,
- Tadeka N.
- 10.↵
- Gurtler L.
- 11.↵
- Horowitz B.
- 12.↵
- Horaud F.,
- Brown F.
- Vicari G.
- 13.↵
- Hollak C. E. M.,
- vom Dahi S.,
- Aerts J. M.,
- Belmatoug N.,
- Bembi B.,
- Cohen Y.,
- Collin-Histed T.,
- Deegan P.,
- van Dussen L.,
- Giraldo P.,
- Mengel E.,
- Michelakakis H.,
- Manuel J.,
- Hrebicek M.,
- Parini R.,
- Reinke J.,
- di Rocco M.,
- Pocovi M.,
- Sa Miranda MC.,
- Tylki-Szymanska A.,
- Zimran A.,
- Cox TM.
- 14.↵
- 15.↵
- Victoria J. G.,
- Wang C.,
- Jones M. S.,
- Jaing C.,
- McLoughlin K.,
- Gardner S.,
- Delwart E. L.
- 16.↵
Code of Federal Regulations, Title 9, Animal and Animal Products (current year): Part 113.53, Requirements for ingredients of animal origin used for production of biologics. Office of the Federal Register, National Archives and Records Administration, U.S. Government Printing Office: Washington DC. January 1, 2010.
- 17.↵
- Chen D.,
- Nims R.,
- Dusing S.,
- Miller P.,
- Luo W.,
- Quertinmont M.,
- Parekh B.,
- Poorbaugh J.,
- Boose J. A.,
- Atkinson E. M.
- 18.↵
- Brown F.,
- Lewis A. M.,
- Peden K.,
- Krause P.
- Hayflick L.
- 19.↵
- 20.↵
- Khan A. S.
- 21.↵
- Horaud F.,
- Brown F.
- Erickson G. A.,
- Bolin S. R.,
- Landgraf J. G.
- 22.↵
- Brown F.,
- Lewis A. M.,
- Peden K.,
- Krause P.
- Griffiths E.
- 23.↵
- Horaud F.,
- Brown F.
- Hay R. J.
- 24.↵
- Merten O. W.
- 25.↵
- 26.↵
- 27.↵
Center for Biologics Evaluation and Research (CBER). Points to consider in the characterization of cell lines used to produce biologicals. U.S. Food and Drug Administration (FDA): Rockville, MD, July 1993.
- 28.↵
CBER. Points to consider in the manufacture and testing of monoclonal antibody products for human use. U.S. FDA: Rockville, MD, February 1997.
- 29.↵
CBER. Guidance for industry: Characterization and qualification of cell substrates and other biological materials used in the production of viral vaccines for infectious disease indications. U.S. FDA: Rockville, MD, February 2010.
- 30.↵
CBER. Guidance for industry: Supplemental guidance on testing for replication competent retrovirus in retroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors. U.S. FDA: Rockville, MD, November 2006.
- 31.↵
CBER. Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans. April 2003.
- 32.↵
Code of Federal Regulations, Title 21, Part 610. Food and Drugs, General Biological Products Standards. Office of the Federal Register, National Archives and Records Administration, U.S. Government Printing Office: Washington, DC. April 1, 2009.
- 33.↵
International Conference on Harmonization. ICH Topics Q5D—Guidance on derivation and characterization of cell substrates used for production of biotechnological/biological products. 21 Sept 1998.
- 34.↵
International Conference on Harmonisation. ICH Topics Q5A(R1)—Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. 23 Sept 1999.
- 35.↵
World Health Organization (WHO). WHO Expert Committee on Biological Standardization, 47th Report: Requirements for the use of animal cells as in vitro substrates for the production of biologicals. WHO Technical Report Series, No. 878, annex 1., 1998.
- 36.↵
- Ulrey A. K.,
- Curren R. D.,
- Raabe H. A.
- 37.↵
- 38.↵
- 39.↵
- Harasawa R.,
- Tomiyama T.
- 40.↵
- 41.↵
- 42.↵
- 43.↵
- 44.↵
- 45.↵
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 5
September/October 2010
Regulatory Considerations for Raw Materials Used in Biological Products
A. S. Khan
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 451-457;
Jump to section
- Article
- Abstract
- Introduction
- History of Virus Contaminations Due to Raw Materials
- Safety Issues Related to Biological Raw Materials
- Considerations for Developing a Comprehensive Testing Scheme for Product Safety
- Qualification and Management of Raw Materials
- Efforts toward Designing Safety in Biologics
- Acknowledgments
- References
- Figures & Data
- References
- Info & Metrics
Related Articles
- No related articles found.
Cited By...
- A Multicenter Study To Evaluate the Performance of High-Throughput Sequencing for Virus Detection
- Mouse Minute Virus (MMV) Contamination--A Case Study: Detection, Root Cause Determination, and Corrective Actions
- Detection of Latent Retroviruses in Vaccine-related Cell Substrates: Investigation of RT Activity Produced by Chemical Induction of Vero Cells
- Current Testing Methods and Challenges for Detection of Adventitious Viruses