Application of PCR technology in vaccine product development

References

• Saiki RK, Scharf S, Faloona F et al. Enzymatic amplification of β-globin genomic sequences and restriction site analysis for diagnosis of sickle cell anemia. Science230(4732), 1350–1354 (1985).
   PubMed Web of Science ®Google Scholar
• Saiki RK, Gelfand DH, Stoffel S et al. Primer-directed enzymatic amplification of DNA with a thermostable DNA polymerase. Science239(4839), 487–491 (1988).
   PubMed Web of Science ®Google Scholar
• Higuchi R, Fockler C, Dollinger G, Watson R. Kinetic PCR analysis: real-time monitoring of DNA amplification reactions. Biotechnology11(9), 1026–1030 (1993).
   PubMed Web of Science ®Google Scholar
• Ginzinger DG. Gene quantification using real-time quantitative PCR: an emerging technology hits the mainstream. Exp. Hematol.30, 503–512 (2002).
   PubMed Web of Science ®Google Scholar
• Tyagi S, Kramer FR. Molecular beacons: probes that fluoresce upon hybridization. Nat. Biotechnol.14(3), 303–308 (1996).
   PubMed Web of Science ®Google Scholar
• Winn-Deen ES. Direct fluorescence detection of allele-specific PCR products using novel energy-transfer labeled primers. Mol. Diagn.3(4), 217–221(1998).
   PubMedGoogle Scholar
• Whitcombe D, Theaker J, Guy SP, Brown T, Little S. Detection of PCR products using self-probing amplicons and fluorescence. Nat. Biotechnol.17(8), 804–807 (1999).
   PubMed Web of Science ®Google Scholar
• Center for Biologics Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services. Draft Guidance for Industry. Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases. (2006).
   Google Scholar
• Dang-Tan T, Mahmud SM, Puntoni R, Franco EL. Polio vaccines, simian virus 40, and human cancer: the epidemiologic evidence for a causal association. Oncogene23(38), 6535–6540 (2004).
   PubMedGoogle Scholar
• Center for Biologics Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services. Points to Consider in the Characterization of Cell Lines used to Produce Biologicals. (1993).
   Google Scholar
• Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, Q5A(R1). International Conference on Harmonization. (1999).
   Google Scholar
• Derivation and characterisation of cell substrates used for production of biotechnological/biological products, Q5D. International Conference on Harmonization. (1997).
   Google Scholar
• Lewis JA, Brown EL, Duncan PA. Approaches to the release of a master cell bank of PER.C6 cells: a novel cell substrate for the manufacture of human vaccines. In; Vaccine Cell Substrates 2004. Developments in Biologicals. Petricciani J, Sheets R (Eds). Karger, Basel, Switzerland, 123, 165–176 (2004).
   Google Scholar
• Rose TM. CODEHOP-mediated PCR – a powerful technique for the identification and characterization of viral genomes. Virol J.2, 20 (2005).
   PubMedGoogle Scholar
• Center for Biologics Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services. Letter to viral vaccine manufacturers. (1998).
   Google Scholar
• Silver J, Maudru, T, Fujita K. An RT-PCR assay for the enzyme activity of reverse transcriptase capable of detecting single virions. Nucleic Acids Res.21(15), 3593–3594 (1993).
   PubMed Web of Science ®Google Scholar
• Pyra H, Boni J, Schupbach J. Ultrasensitive retrovirus detection by a reverse transcriptase assay based on product enhancement. Proc. Natl Acad. Sci. USA91(4), 1544–1548 (1994).
   PubMed Web of Science ®Google Scholar
• Maudru T, Peden K. Elimination of background signals in a modified polymerase chain reaction-based reverse transcriptase assay. J. Virol. Methods66(2), 247–261 (1997).
   PubMedGoogle Scholar
• European Pharmacopeia, Section 2.6.7 (Mycoplasma). Fifth Edition (2005).
   Google Scholar
• Deatly AM, McAuliffe JM. Use of the polymerase chain reaction to screen cell banks for retroviruses. In: Viral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products. Developments in biological standardization. Brown F, Lubiniecki AS (Eds). Karger, Basel, Switzerland, 177–188 (1996).
   Google Scholar
• Duncan P, McKerral L, Feng S et al. Detection breadth and limits for potential adventitious/endogenous contaminants in biopharmaceutical processes: a reality check for innovative methods. In: New Diagnostic Technology: Applications in Animal Health and Biologics Controls. Vannier P, Espeseth D (Eds.). Karger, Basel, Switzerland, 283–290 (2006).
   Google Scholar
• Heid CA, Stevens J, Livak KJ. Real time quantitative PCR. Genome Res.6, 986–994 (1996).
   PubMed Web of Science ®Google Scholar
• Shiver JW, Fu TM, Chen L et al. Replication-incompetent adenoviral vaccine vector elicits effective anti-immunodeficiency-virus immunity. Nature.415, 331–335 (2002).
   PubMed Web of Science ®Google Scholar
• Shenk T. Adenoviridae: the viruses and their replication. In: Fields Virology Howley PM (Ed.). Lippincott-Raven Publishers, PA, USA, 2111–2148 (1996).
   Google Scholar
• Graham FL, Smiley J, Russell WC et al. Characteristics of a human cell line transformed by DNA from human adenovirus type 5. J. Gen. Virol.36, 59–74 (1977).
   PubMed Web of Science ®Google Scholar
• Fallaux FJ, Bout A, van der Velde I et al. New helper cells and matched early region 1-deleted adenovirus vectors prevent generation of replication-competent adenoviruses. Hum. Gene Ther.9, 1909–1917 (1998).
   PubMed Web of Science ®Google Scholar
• Maizel JV, White DO, Scharff MD. The polypeptides of adenovirus: evidence for multiple protein components in the virions and a comparison of types 2, 7A and 12. Virology36, 115–125 (1968).
   PubMedGoogle Scholar
• Sweeney JA, Hennessey JP. Evaluation of accuracy and precision of adenovirus absorptivity at 260nm under conditions of complete DNA disruption. Virology295, 284–288 (2002).
   PubMedGoogle Scholar
• Shabram PW, Giroux DD, Goudreau AM et al. Analytical anion-exchange HPLC of recombinant type-5 adenoviral particles. Hum. Gene Ther.8, 453–465 (1997).
   PubMed Web of Science ®Google Scholar
• Ma L, Bluyssen HA, De Raeymaeker M, et al. Rapid determination of adenoviral vector titers by quantitative real-time PCR. J. Virol. Methods93, 181–188 (2001).
   PubMedGoogle Scholar
• Wang L, Wang CJ, Tan CY, Hsu D, Hennessey JP. 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. Hum. Gene Ther.17(7), 728–740 (2006).
   PubMedGoogle Scholar
• Altaras NE, Aunins JG, Evans RK, Kamen A, Konz JO, Wolf JJ. Production and formulation of adenovirus vectors. Adv. Biochem. Eng. Biotechnol.99, 193–260 (2005).
   PubMed Web of Science ®Google Scholar
• Wang F, Mathis BC, Montalvo A et al. Quantifying the titer and quality of adenovirus stocks in gene therapy protocols, 3rd edition. Methods in Molecular Medicine DeDoux J (Ed.). Humana Press (2007).
   Google Scholar
• Lewis JA, Ranheim TS, Wang F et al. Novel use of QPCR technology to assay the potency of live virus vaccines. In: Fifth Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Products. (2001).
   Google Scholar
• Wang F, Puddy AC, Mathis BC et al. Using QPCR to assign infectious potencies to adenovirus based vaccines and vectors for gene therapy. Vaccine23, 4500–4508 (2005).
   PubMed Web of Science ®Google Scholar
• Schalk JA, van den Elzen C, Ovelgonne H, Baas C, Jongen PM. Estimation of the number of infectious measles viruses in live virus vaccines using quantitative real-time PCR. J. Virol. Methods117(2), 179–187 (2004).
   PubMed Web of Science ®Google Scholar
• Schalk JA, de Vries CG, Jongen PM. Potency estimation of measles, mumps and rubella trivalent vaccines with quantitative PCR infectivity assay. J. Virol. Methods33, 71–79 (2005).
   Google Scholar
• Ranheim T, Mathis PK, Joelsson DB et al. Development and application of a quantitative RT-PCR potency assay for a pentavalent rotavirus vaccine (RotaTeq). J. Virol. Methods131, 193–201 (2006).
   PubMed Web of Science ®Google Scholar
• Wierenga DE, Cogan J, Petriccaini JC. Administration of tumor cell chromatin to immunosuppressed and non-immunosuppressed primates. Biologicals23, 221–224 (1995).
   PubMedGoogle Scholar
• Duxbury M, Jezuit M, Letwin B et al. DNA in plasma of human blood for transfusion. Biologicals23(3), 229–231 (1995).
   PubMedGoogle Scholar
• Nawroz H, Koch W, Anker P, Stroun M, Sidransky D. Microsatellite alterations in serum DNA of head and neck cancer patients. Nat. Med.2(9), 1035–1037 (1996).
   PubMed Web of Science ®Google Scholar
• WHO Expert Committee on Biological Standardization. Forty-Seventh Report, Technical Report Series No. 878. WHO (1998).
   Google Scholar
• Singer VL, Jones LJ, Yue ST, Haugland RP. Characterization of PicoGreen reagent and development of a fluorescence-based solution assay for double-stranded DNA quantitation. Anal. Biochem.249, 228–238 (1997).
   PubMed Web of Science ®Google Scholar
• Gijsbers L, Koel B, Weggeman M, Goudsmit J, Havenga M, Marzio G. Quantification of residual host cell DNA in adenoviral vectors produced on PER.C6® cells. Hum. Gene Ther.16, 1–6 (2005).
   PubMedGoogle Scholar
• Batzer MA, Deininger PL. Alu repeats and human genomic diversity. Nat. Rev. Genet.3(5), 370–379 (2002).
   PubMed Web of Science ®Google Scholar
• Kutyavin IV, Afonina IA, Vladimir AM et al. 3´-minor groove binder-DNA probes increase sequence specificity at PCR extension temperatures. Hum. Gene Ther.28(2), 655–661 (2000).
   Google Scholar
• Murakami P, McCaman MT. Quantitation of adenovirus DNA and virus particles with PicoGreen fluorescent dye. Anal. Biochem.274, 283–288 (1999).
   PubMed Web of Science ®Google Scholar
• Briggs J, Panfili R. Quantitation of DNA and protein impurities in biopharmaceuticals. Anal. Chem.63, 850–859 (1991).
   PubMedGoogle Scholar
• Pepin RA, Lucas DJ, Lang RB, Lee N, Liao MJ, Testa D. Detection of picogram amounts of nucleic acid by dot blot hybridization. BioTechniques8, 628–632 (1990).
   PubMedGoogle Scholar
• Lokteff M, Klinguer-Hamour C, Julien E et al. Residual DNA quantification in clinical batches of BBG2Na, a recombinant subunit vaccine against human respiratory syncytial virus. Biologicals29, 123–132 (2001).
   PubMedGoogle Scholar
• Wolter T, Richter A. Assay for controlling host-cell impurities in biopharmaceuticals. BioProcess Int.3(2), 40–46 (2005).
   Google Scholar
• Griffiths SA, Lumley CE. Non-clinical safety studies for biotechnologically-derived pharmaceuticals: conclusions from an international workshop. Hum. Exp. Toxicol.17(2), 63–83 (1998).
   PubMedGoogle Scholar
• Ye X, Gao GP, Pabin C, Raper SE, Wilson JM. Evaluating the potential of germ line transmission after intravenous administration of recombinant adenovirus in the C3H mouse. Hum Gene Ther.9(14), 2135–2142 (1998).
   PubMed Web of Science ®Google Scholar
• WHO. Guidelines for Assuring the Quality and Nonclinical Safety Evaluation of DNA Vaccines. WHO Expert Committee on Biological Standardization (2005).
   Google Scholar
• Center for Biologics Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services. Guidance for Industry. Gene therapy clinical trials - observing subjects for delayed adverse events (2006).
   Google Scholar
• Silver J, Keerikatte V. Novel use of polymerase chain reaction to amplify cellular DNA adjacent to an integrated provirus. J. Virol.63(5), 1924–1928 (1986).
   Google Scholar
• Izsvak Z, Ivics Z. Two-stage ligation-mediated PCR enhances the detection of integrated transgenic DNA. BioTechniques15(5), 814–818 (1993).
   PubMedGoogle Scholar
• Nichols WW, Ledwith BJ, Manam SV, Troilo PJ. Potential DNA vaccine integration into host cell genome. Ann. NY Acad Sci.772, 30–39 (1995).
   PubMed Web of Science ®Google Scholar
• Ledwith BJ, Manam S, Troilo PJ et al. Plasmid DNA vaccines: investigation of integration into host cellular DNA following intramuscular injection in mice. Intervirology.43(4–6), 258–272 (2000).
   PubMed Web of Science ®Google Scholar
• Ledwith BJ, Manam S, Troilo PJ et al. Plasmid DNA vaccines: assay for integration into host genomic DNA. Dev. Biol. (Basel)104, 33–43 (2000).
   PubMedGoogle Scholar
• Wang Z, Troilo PJ, Wang X et al. Detection of integration of plasmid DNA into host genomic DNA following intramuscular injection and electroporation. Gene Ther.11(8), 711–21(2004).
   PubMed Web of Science ®Google Scholar
• Andrews L, Andersen RF, Webster D et al. Quantitative real-time polymerase chain reaction for malaria diagnosis and its use in malaria vaccine clinical trials. 73(1), 191–198 (2005).
   Google Scholar
• Reizenstein E, Lindberg L, Möllby R, Hallander HO. Validation of nested Bordetella PCR in pertussis vaccine trial. J. Clin. Microbiol.34(4), 810–815 (1996).
   PubMed Web of Science ®Google Scholar
• Wang F, Patel DK, Antonello JM et al. Development of an adenovirus shedding assay for detection of adenoviral vector based vaccine and gene therapy products in clinical specimens. Hum. Gene Ther.14(1), 25–36 (2003).
   PubMedGoogle Scholar
• Druce J, Catton M. Chibo D et al. Utility of a multiplex PCR assay for detecting herpesvirus DNA in clinical samples. J. Clin. Microbiol.40(5), 1728–1732 (2002).
   PubMedGoogle Scholar
• Read SJ, Kurtz JB. Laboratory diagnosis of common viral infections of the central nervous system by using a single multiplex PCR screening assay. J. Clin. Microbiol.37(5), 1352–1355 (1999).
   PubMed Web of Science ®Google Scholar
• Espy MJ, Uhl JR, Sloan LM et al. Real-time PCR in clinical microbiology: applications for routine laboratory testing. Clin. Microbiol. Rev.19(1), 165–256 (2006).
   PubMed Web of Science ®Google Scholar