A robust approach for the quantitation of viral concentration in an adenoviral vector-based human immunodeficiency virus vaccine by real-time quantitative polymerase chain reaction

Human Gene Therapy

Volumn 17, Issue 7, 2006, Pages 728-740

  Wang, Liman ^a   Wang, Christopher J ^a   Tan, Charles Y ^a   Hsu, David ^a,b   Hennessey Jr , John P ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADENOVIRUS VECTOR; GENE PRODUCT; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; PLASMID DNA; VIRUS DNA;

ACCURACY; ADENOVIRUS REFERENCE MATERIAL WORKING GROUP; ADENOVIRUS REFERENCE STANDARD; ANALYTIC METHOD; ARTICLE; AUTOMATION; DATA ANALYSIS; DRUG FORMULATION; DRUG RELEASE; EVALUATION; GENOME QUANTITATION ASSAY; HIGH THROUGHPUT SCREENING; HUMAN IMMUNODEFICIENCY VIRUS; INTERMETHOD COMPARISON; LIQUID TRANSFER SYSTEM; LYSIS; NONHUMAN; PARALLEL LINE DATA ANALYSIS; PROCESS MONITORING; QUANTITATIVE ASSAY; REAL TIME POLYMERASE CHAIN REACTION; RELIABILITY; RETROVIRUS; STANDARD; TRANSGENE; VARIANCE; VIRUS GENOME; VIRUS RECOMBINANT; VIRUS TITRATION;

ADENOVIRIDAE; AIDS VACCINES; DNA PRIMERS; DNA, VIRAL; GENETIC VECTORS; HIV-1; HUMANS; POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY;

ADENOVIRIDAE; HUMAN IMMUNODEFICIENCY VIRUS;

EID: 33746267429     PISSN: 10430342     EISSN: None     Source Type: Journal    
DOI: 10.1089/hum.2006.17.728     Document Type: Article

References (31)

1. AFONINA, I., ZIVARTS, M., KUTYAVIN, I., LUKHTANOV, E., GAMPER, H., and MEYER, R.B. (1997). Efficient priming of PCR with short oligonucleotides conjugated to a minor groove binder. Nucleic Acids Res. 25, 2657-2660.
2. BLANCHE, F., CAMERON, B., BARBOT, A., FERRERO, L., GUILLEMIN, T., GUYOT, S., SOMARRIBA, S., and BISCH, D. (2000). An improved anion-exchange HPLC method for the detection and purification of adenoviral particles. Gene Ther. 7, 1055-1062.
3. CALLAHAN, J.D. (2002). A statistical analysis of Adenovirus Reference Material assay results. Bioprocessing 1, 43-47.
4. EVANS, R.K., NAWROCKI, D.K., ISOPI, L.A., WILLIAMS, D.M., CASIMIRO, D.R., CHIN, S., CHEN, M., ZHU, D.M., SHIVER, J.W., and VOLKIN, D.B. (2004). Development of stable liquid formulations for adenovirus-based vaccines. J. Pharm. Sci. 93, 2458-2475.
5. FINNEY, D.J. (1978). Statistical Method in Biological Assay, 3rd ed. (Charles Griffin & Company, London).
6. GINZINGER, D.G. (2002). Gene quantification using real-time quantitative PCR: An emerging technology hits the mainstream. Exp. Hematol. 30, 503-512.
7. HEID, C.A., STEVENS, J., LIVAK, K.J., and WILLIAMS, P.M. (1996). Real-time quantitative PCR. Genome Res. 6, 986-994.
8. HEIM, A., EBNET, C., HARSTE, G., and PRING-AKERBLOM, P. (2003). Rapid and quantitative detection of human adenovirus DNA by real-time PCR. J. Med. Virol. 70, 228-239.
9. HUTCHINS, B. (2002). Development of a reference material for characterizing adenovirus vectors. Bioprocessing 1, 25-28.
10. JONES, L.J., HAUGLAND, R.P., and SINGER, V.L. (2003). Development and characterization of the NanoOrange protein quantitation assay: A fluorescence-based assay of proteins in solution. Biotechniques 34, 850-854.
11. KARSAI, A., MULLER, S., PLATZ, S., and HAUSER, M.T. (2002). Evaluation of a homemade SYBR green I reaction mixture for real-time PCR quantification of gene expression. Biotechniques 32, 790-796.
12. KUTYAVIN, I.V., AFONINA, I.A., MILLS, A., GORN, V.V., LUKHTANOV, E.A., BELOUSOV, E.S., SINGER, M.J., WALBURGER, D.K., LOKHOV, S.G., GALL, A.A., DEMPCY, R., REED, M.W., MEYER, R.B., and HEDGPETH, J. (2000). 3′-Minor groove binder-DNA probes increase sequence specificity at PCR extension temperatures. Nucleic Acids Res. 28, 655-661.
13. LANSKY, D. (2002). Strip-plot designs, mixed models, and comparisons between linear and non-linear models for microtiter plate bioassays. In Browen, F., and Mire-Sluis, A., eds. The Design and Analysis of Potency Assays for Biotechnology Products, Vol. 107 (Karger, Basel, Switzerland) pp. 11-23.
14. LOWRY, O.H., ROSEBROUGH, N.J., FARR, A.L., and RANDALL, R. (1951). Protein measurement with the folin phenol reagent. J. Biol. Chem. 193, 265-275.
15. MA, L., BLUYSSEN, H.A., DE RAEYMAEKER, M., LAURYSENS, V., VAN DER BEEK, N., PAVLISKA, H., VAN ZONNEVELD, A.J., TOMME, P., and VAN ES, H.H. (2001). Rapid determination of adenoviral vector titers by quantitative real-time PCR. J. Virol. Methods 93, 181-188.
16. MAIZEL, J.V., WHITE, D.O., and SHARFF, M.D. (1968). The polypeptides of adenovirus. I. Evidence for multiple protein components in the virion and comparison of types 2, 7A and 12. Virology 36, 115-125.
17. MURAKAMI, P., and MCCAMAN, M. (1999). Quantitation of adenovirus DNA and virus particles with the PicoGreen fluorescent dye. Anal. Biochem. 274, 283-288.
18. NIH RECOMBINANT DNA ADVISORY COMMITTEE. (2002). Assessment of adenoviral vector safety and toxicity: Report of the National Institutes of Health Recombinant DNA Advisory Committee. Hum. Gene Ther. 13, 3-13.
19. RODRIGUEZ-VICO, F., MARTINEZ-CAYUELA, M., GARCIA-PEREGRIN, E., and RAMIREZ, H. (1989). A procedure for eliminating interferences in the Lowry method of protein determination. Anal. Biochem. 183, 275-278.
20. ROHR, U., WULF, M., STAHN, S., ULRICH, S., HAAS, R., and KRONENWETT, R. (2002). Fast and reliable titration of recombinant adeno-associated virus type-2 using quantitative real-time PCR. J. Virol. Methods 106, 81-88.
21. SCHOFIELD, T.L. (2000). Assay development. In Chow, S.-C., ed. Encyclopedia of Biopharmaceutical Statistics (Marcel Dekker, New York) pp. 13-21.
22. SHABRAM, P.W., GIROUX, D.D., GOUDREAU, A.M., GREGORY, R.J., HORN, M.T., HUYGHE, B.G., LIU, X., NUNNALLY, M.H., SUGARMAN, B.J., and SUTJIPTO, S. (1997). Analytical anion-exchange HPLC of recombinant type-5 adenoviral particles. Hum. Gene Ther. 8, 453-465.
23. SHIVER, J.W., FU, T.M., CHEN, L., CASIMIRO, D.R., DAVIES, M.E., EVANS, R.K., ZHANG, Z.Q., SIMON, A.J., TRIGONA, W.L., DUBEY, S.A., HUANG, L., HARRIS, V.A., LONG, R.S., LIANG, X., HANDT, L., SCHLEIF, W.A., ZHU, L., FREED, D.C., PERSAUD, N.V., GUAN, L., PUNT, K.S., TANG, A., CHEN, M., WILSON, K.A., COLLINS, K.B., HEIDECKER, G.J., FERNANDEZ, V.R., PERRY, H.C., JOYCE, J.G., GRIMM, K.M., COOK, J.C., KELLER, P.M., KRESOCK, D.S., MACH, H., TROUTMAN, R.D., ISOPI, L.A., WILLIAMS, D.M., XU, Z., BOHANNON, K.E., VOLKIN, D.B., MONTEFIORI, D.C., MIURA, A., KRIVULKA, G.R., LIFTON, M.A., KURODA, M.J., SCHMITZ, J.E., LETVIN, N.L., CAULFIELD, M.J., BETT, A.J., YOUIL, R., KASLOW, D.C., and EMINI, E.A. (2002). Replication-incompetent adenoviral vaccine vector elicits effective anti-immunodeficiency-virus immunity. Nature 415, 331-335.
24. SIMEK, S., BYRNES, A., and BAUER, S. (2002). FDA perspectives on the use of the Adenovirus Reference Material. Bioprocessing 1, 40-42.
25. SMITH, P.K., KROHN, R.I., HERMANSON, G.T., MALLIA, A.K., GARTNER, F.H., PROVENZANO, M.D., FUJIMOTO, E.K., GOEKE, N.M., OLSON, B.J., and KLENK, D.C. (1985). Measurement of protein using bicinchoninic acid. Anal. Biochem. 150, 76-85.
26. SUTJIPTO, S., RAVINDRAN, S., CORNELL, D., LIU, Y.H., HORN, M., SCHLUEP, T., HUTCHINS, B., and VELLEKAMP, G. (2005). Characterization of empty capsids from a conditionally replicating adenovirus for gene therapy. Hum. Gene Ther. 16, 109-125.
27. SWEENEY, J., and HENNESSEY, J.P., Jr. (2002). Evaluation of accuracy and precision of adenovirus absorptivity at 260 nm under conditions of complete DNA disruption. Virology 295, 284-288.
28. TAKAHASHI, E., COHEN, S.L., TSAI, P.K., and SWEENEY, J.A. (2006). Quantitation of adenovirus type 5 empty capsids. Anal. Biochem. 349, 208-217.
29. TEICHLER-ZALLEN, D. (2000). US gene therapy in crisis. Trends Genet. 16, 272-275.
30. VELLEKAMP, G., PORTER, F.W., SUTJIPTO, S., CUTLER, C., BONDOC, L., LIU, Y.H., WYLIE, D., CANNON-CARLSON, S., TANG, J.T., FREI, A., VOLOCH, M., and ZHUANG, S. (2001). Empty capsids in column-purified recombinant adenovirus preparations. Hum. Gene Ther. 12, 1923-1936.
31. WANG, Y., and HUANG, S. (2000). Adenovirus technology for gene manipulation and functional studies. Drug Discov. Today 5, 10-16.