Testing considerations for novel cell substrates: A regulatory perspective

PDA Journal of Pharmaceutical Science and Technology

Volumn 64, Issue 5, 2010, Pages 426-431

  Khan, A S ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Adventitious agents; Cell banks; Chemical induction; Dna oncogenicity; End of production cells; Endogenous retroviruses; Latent viruses; Novel cell substrates; Tumorigenic cells; Viral vaccines

Indexed keywords

ANIMAL TISSUE VACCINE; BIOLOGICAL PRODUCT; CONTINUOUS CELL VACCINE; DIPLOID CELL VACCINE; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; INFLUENZA VACCINE; MONOCLONAL ANTIBODY; NOVEL CELL SUBSTRATE; PRIMARY CELL CULTURE VACCINE; TELOMERASE; UNCLASSIFIED DRUG; VACCINE; VIRUS VACCINE; VIRUS VECTOR; RECOMBINANT VACCINE;

ADENOVIRUS 5; ANIMAL CELL; BACTERIUM; CANCER CELL; CANCER GENE THERAPY; CHO CELL; CONFERENCE PAPER; DRUG CONTAMINATION; DRUG SAFETY; EMBRYONIC STEM CELL; FOWL; GENETIC ENGINEERING; HUMAN; HUMAN CELL; INSECT CELL; LYMPHOCYTIC CHORIOMENINGITIS VIRUS; NONHUMAN; PANDEMIC INFLUENZA; PLANT CELL; RETROVIRUS; STABLE TRANSFECTION; TRANSGENIC ANIMAL; VERO CELL; GENE THERAPY; GENE VECTOR; IMMUNOLOGY; NEOPLASM; VIRUS;

AIDS VACCINES; BIOLOGICAL PRODUCTS; GENETIC THERAPY; GENETIC VECTORS; HUMANS; INFLUENZA VACCINES; NEOPLASMS; VACCINES, SYNTHETIC; VIRUSES;

EID: 78149344560     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (22)

1. Khan A. S. Regulatory considerations for raw materials used in biological products. PDA J. Pharm. Sci. Tech. 2010, 64 (5).
2. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ ucm093833.htm.
3. Center for Biologics Evaluation and Research (CBER). Points to consider in the characterization of cell lines used to produce biologicals. US Food and Drug Administration, Rockville, MD; July 1993.
4. CBER. Points to consider in the manufacture and testing of therapeutic products for human use derived from transgenic animals. Rockville, MD; January 1995.
5. CBER. Points to consider in the manufacture and testing of monoclonal antibody products for human use. Rockville, MD; February 1997.
6. CBER. Guidance for industry: Source animal, product, preclinical, and clinical issues concerning the use of xenotransplantation products in humans. April 2003.
7. 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. November 2006.
8. 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. Rockville, MD; February 2010.
9. Griffiths, E. Major issues associated with the use of cell substrates for the production of vaccines. Dev. Biol. (Basel) 2001, 106, 25-36.
10. Hayflick, L. A brief history of cell substrates used for the preparation of human biologicals. Dev. Biol. (Basel) 2001, 106, 5-24.
11. Khan, A. S. Characterization and qualification of cell substrates for manufacturing viral vaccines in the United States. BioProcessing J. 2009, 8 (3), 8-12.
12. Hayflick, L. History of cell substrates used for human biologicals. Dev. Biol. Stand. 1989, 70, 11-26.
13. Petricciani, J. C. Cells, Science and Health. In Continuous Cell Lines as Substrates for Biologicals; Hayflick, L., Hennessen, W., Eds.: Dev. Biol. Standard, Karger: Basel, 1989; Vol. 70, pp 3-10.
14. Horaud, F. Absence of viral sequences in the WHO-VERO Cell Bank. A collaborative study. Dev. Biol. Stand. 1992, 76, 43-46.
15. Swanson, S. K.; Mento, S. J.; Weeks-Levy, C.; Brock, B. D.; Kowal, K. J.; Wallace, R. E.; Ritchey, M. B.; Cano, F. R. Characterization of Vero cells. J. Biol. Stand. 1988, 16 (4), 311-320.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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.
21. Khan, A. S.; Ma, W.; Ma, Y. K.; Kumar, A.; Williams, D. K.; Muller, J.; Ma, H.; Galvin, T. A. Proposed algorithm to investigate latent and occult viruses in vaccine cell substrates by chemical induction. Biologicals 2009, 37 (3), 196-201.
22. Raeber, A. J.; Oesch, B. Diagnostics for TSE agents. In Vaccine Cell Substrates; Petricciani, J., Sheets R, Eds.; 2004. Dev. Biol. (Basel), Karger: Basel, 2006; Vol. 123, pp. 313-323.