A Statistical Approach to Determining Criticality of Residual Host Cell DNA

REFERENCES

• Arfaj, A. S. A., Chowdhary, A. R., Khalil, N., Ali, R. (2007). Immunogenicity of singlet oxygen modified human DNA: Implications for anti-DNA antibodies in systemic lupus erythematosus. Clinical Immunology 124:83–89.
   PubMed Web of Science ®Google Scholar
• Dortant, P. M., Claassen, I. J. T. M., van Kreyl, C. F., van Steenis, G., and Wester, P. W. (1997). Risk assessment on the carcinogenic potential of hybridoma cell DNA: Implications for residual contaminating cellular DNA in biological products. Biologicals 25:381–390.
   PubMed Web of Science ®Google Scholar
• Goff, S. P. (1999). Retroviridae: The retroviruses and their replication. In Knipe, D. M., Howley, P. M., eds. Fundamental Virology, 4th ed. Philadelphia, PA: Lippincott Williams & Wilkins, pp. 843–911.
   Google Scholar
• Haight, F. A. (1967). Handbook of the Poisson Distribution. New York, NY: John Wiley & Sons.
   Google Scholar
• ICH Q8 (R2). (2009). ICH Harmonised Tripartite Guideline on Pharmaceutical Development. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf.
   Google Scholar
• ICH Q9. (2005). ICH Harmonised Tripartite Guideline on Quality Risk Management. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf.
   Google Scholar
• ICH Q10. (2007). ICH Harmonised Tripartite Guideline on Pharmaceutical Quality Systems. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf.
   Google Scholar
• ICH Q11. (2011). ICH Harmonised Tripartite Guideline on Development and Manufacture of Drug Substances (Chemical entities and biotechnological/biological entities). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf.
   Google Scholar
• Ishii, K. J., Gursel, I., Gursel, M., Klinman, D. M. (2004). Immunotherapeutic utility of stimulatory and suppressive oligodeoxynucleotides. Current Opinion in Molecular Therapeutics 6:166–174.
   PubMed Web of Science ®Google Scholar
• Klinmann, D. M., Xie, H., Ivins, B. E. (2006). CpG oligonucleotides improve the protective immune response induced by the licensed anthrax vaccine. Annals of the New York Academy of Sciences 1082:137–150.
   PubMed Web of Science ®Google Scholar
• Klinmann, D. M., Yamshchikov, G., Ishigatsubo, Y. (1997). Contribution of CpG motifs to the immunogenicity of DNA vaccines. Journal of Immunology 158:3635–3639.
   PubMed Web of Science ®Google Scholar
• Kojima, Y., Xin, K.-Q., Ooki, T., Hamajima, K., Oikawa, T., Shinoda, K., Ozaki, T., Hoshino, Y., Jounai, N., Nakazawa, M., Kinman, D., Okuda, K. (2002). Adjuvant effect of multi-CpG motifs on an HIV-1 DNA vaccine. Vaccine 20:2857–2865.
   PubMed Web of Science ®Google Scholar
• Kozlowski, S., Swann, P. (2009). Considerations for biotechnology product quality by design. In Quality by Design for Biopharmaceutical: Principles and Case Studies (eds. Rathore, A. S., Mhatre, R.) New York, NY: Wiley.
   Google Scholar
• Peden, K., Sheng, L., Pal, A., Lewis, A. (2006). Biological activity of residual cell substrate DNA. Dev. Biol. (Basel) 123: 45–56; discussion 55–73.
   Google Scholar
• Petricciani, J., Loewer, J. (2001). An overview of cell DNA issues. Dev. Biol. 106:275–282.
   Google Scholar
• Rathore, A. S., Mhatre, R. (2009). Quality by Design for Biopharmaceutical: Principles and Case Studies. New York, NY: Wiley.
   Google Scholar
• Rothenfusser, S., Tuma, E., Wagner, M., Endres, S., Hartmann, G. (2003). Recent advance in immunostimulatory CpG oligonucleotides. Current Opinion in Molecular Therapeutics 5:98–106.
   PubMed Web of Science ®Google Scholar
• Schenerman, M. A., Axley, M. J., Oliver, C. N., Ram, K., Wasserman, G. F. (2009). Using a risk assessment process to determine criticality of product quality attributes. In Quality by Design for Biopharmaceutical: Principles and Case Studies (eds. Rathore, A. S., Mhatre, R.) New York, NY: Wiley.
   Google Scholar
• Sheng, L., Cai, F., Zhu, Y., Pal, A., Athanasiou, M., Orrison, B., Blair, D. G., Hughes, S. H., Coffin, J. M., Lewis, A. M., Peden, K. (2008). Oncogenicity of DNA in vivo: Tumor induction with expression plasmids for activated H-ras and c-myc. Biologicals 36:184–197.
   PubMed Web of Science ®Google Scholar
• Sheng-Fowler, L., Cai, F., Fu, H., Zhu, Y., Orrison, B., Foseh, G., Blair, D. G., Hughes, S. H., Coffin, J. M., Lewis, A. M. Jr, Peden, K. (2010). Tumors induced in mice by direct inoculation of plasmid DNA expressing both activated H-ras and c-myc. International Journal of Biological Sciences 6:151–162.
   PubMed Web of Science ®Google Scholar
• Sheng-Fowler, L., Lewis, A. M. Jr, Peden, K. (2009a). Issues associated with residual cell-substrate DNA in viral vaccines. Biologicals 37:190–195.
   PubMed Web of Science ®Google Scholar
• Sheng-Fowler, L., Lewis, A. M. Jr, Peden, K. (2009b). Quantitative determination of the infectivity of the proviral DNA of a retrovirus in vitro: Evaluation of methods for DNA inactivation. Biologicals 37:259–269.
   PubMed Web of Science ®Google Scholar
• WHO (World Health Organization). (2007). Meeting Report ( 11–12 June, 2007) Study group on cell substrates for production of biological, 1–30.
   Google Scholar
• Yang, H. (2013a). How many batches are needed for process validation under the new FDA process validation guidance?. PDA Journal of Pharmaceutical Science and Technology January–February Issue. 67:53–62. doi:10.5731/pdajpst.2013.00902
   PubMedGoogle Scholar
• Yang, H. (2013b). Setting specifications of correlated quality attributes. PDA Journal of Pharmaceutical Science and Technology 67, September–October.
   Google Scholar
• Yang, H., Zhang, L., Galinski, L. (2010). A probabilistic model for risk assessment of residual host cell DNA in biological product. Vaccine 28:3308–3311.
   PubMed Web of Science ®Google Scholar
• Zhou, Y., Ma, B.-G., Zhang, H.-Y. (2007). Human oncogene tissue-specific expression level significantly correlates with sequence compositional features. FEBS Letters 581:4361–4365.
   PubMed Web of Science ®Google Scholar