Transposon leads to contamination of clinical pDNA vaccine

Vaccine

Volumn 31, Issue 32, 2013, Pages 3274-3280

  Van der Heijden, I ^a   Gomez Eerland, R ^a   van den Berg, J H ^a   Oosterhuis, K ^a   Schumacher, T N ^a   Haanen, J B A G ^a   Beijnen, J H ^a   Nuijen, B ^a  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

Author keywords

Clinical grade plasmid DNA; DNA vaccination; Gene therapy; GMP; HPV16; Transposon

Indexed keywords

DNA VACCINE; PLASMID DNA; PLASMID VECTOR;

AGAR GEL ELECTROPHORESIS; ANALYTIC METHOD; ARTICLE; BACTERIAL GENOME; BATCH FERMENTATION; CONTROLLED STUDY; COST BENEFIT ANALYSIS; DNA IMMUNIZATION; DRUG CONTAMINATION; DRUG MANUFACTURE; ESCHERICHIA COLI; GEL ELECTROPHORESIS; GENE INSERTION SEQUENCE; GENE SEQUENCE; GOOD MANUFACTURING PRACTICE; HOST CELL; HUMAN PAPILLOMAVIRUS TYPE 16; LIMIT OF DETECTION; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; PROCESS CONTROL; PROCESS DEVELOPMENT; PROTEIN ENGINEERING; QUALITY CONTROL; SEQUENCE ALIGNMENT; TRANSPOSON;

DNA TRANSPOSABLE ELEMENTS; DNA, BACTERIAL; DRUG CONTAMINATION; ESCHERICHIA COLI; FERMENTATION; GENETIC VECTORS; LIMIT OF DETECTION; ONCOGENE PROTEINS, VIRAL; PAPILLOMAVIRUS VACCINES; PLASMIDS; POLYMERASE CHAIN REACTION; QUALITY CONTROL; REPRESSOR PROTEINS; RESTRICTION MAPPING; SEQUENCE ANALYSIS, DNA; VACCINES, DNA;

EID: 84879463364     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2013.05.022     Document Type: Article

References (42)

1. Roden R., Wu T.-C. How will HPV vaccines affect cervical cancer?. Nat Rev Cancer 2006, 6(October (10)):753-763.
2. Frazer I.H., Leggatt G.R., Mattarollo S.R. Prevention and treatment of papillomavirus-related cancers through immunization. Annu Rev Immunol Jan 2011, 29:111-138.
3. Oosterhuis K. Preclinical development of dna vaccine candidates for the treatment of HPV16 induced malignancies. Doctoral Thesis 2012, Leiden University, ISBN 9789461821270.
4. Henken F.E., et al. Preclinical safety evaluation of DNA vaccines encoding modified HPV16 E6 and E7. Vaccine 2012, 30(June (28)):4259-4266.
5. Bins A.D., et al. A rapid and potent DNA vaccination strategy defined by in vivo monitoring of antigen expression. Nat Med 2005, 11(August (8)):899-904.
6. Granucci F., Ferrero E., Foti M., Aggujaro D., Vettoretto K., Ricciardi-Castagnoli P. Early events in dendritic cell maturation induced by LPS. Microbes Infect/Institut Pasteur 1999, 1(November (13)):1079-1084.
7. European Medicines Agency EMEA ICH, guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities). Off J Eur Union 2011, 44(May).
8. Quaak S.G.L., et al. GMP production of pDERMATT for vaccination against melanoma in a phase I clinical trial. Eur J Pharm Biopharm: Off J Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V. 2008, 70(October (2)):429-438.
9. Schleef M., Schmidt T. Animal-free production of ccc-supercoiled plasmids for research and clinical applications. J Gene Med 2004, 6(February (Suppl. 1)):S45-S53.
10. Przybylowski M., Bartido S., Borquez-Ojeda O., Sadelain M., Rivière I. Production of clinical-grade plasmid DNA for human Phase I clinical trials and large animal clinical studies. Vaccine 2007, 25(June (27)):5013-5024.
11. Rozkov A., Larsson B., Gillström S., Björnestedt R., Schmidt S.R. Large-scale production of endotoxin-free plasmids for transient expression in mammalian cell culture. Biotechnol Bioeng 2008, 99(February (3)):557-566.
12. Cai Y., Rodriguez S., Rameswaran R., Draghia-Akli R., Juba R.J., Hebel H. Production of pharmaceutical-grade plasmids at high concentration and high supercoiled percentage. Vaccine 2010, 28(February (8)):2046-2052.
13. Cheng L., Sun X., Yi X., Zhang Y. Large-scale plasmid preparation for transient gene expression. Biotechnol Lett 2011.
14. Saedler H., Heiss B. Multiple copies of the insertion-DNA sequences IS1 and IS2 in the chromosome of E. coli K-12. Mol Gen Genet: MGG 1973, 122(May (3)):267-277.
15. Senejani A.G., Sweasy J.B. Eukaryotic gene invasion by a bacterial mobile insertion sequence element IS2 during cloning into a plasmid vector. Genome Integrity 2010, 1(January (1)):2.
16. Schneider D., Lenski R.E. Dynamics of insertion sequence elements during experimental evolution of bacteria. Res Microbiol 2004, 155(June (5)):319-327.
17. Oliveira P.H., Prazeres D.M.F., Monteiro G.A. Deletion formation mutations in plasmid expression vectors are unfavored by runaway amplification conditions and differentially selected under kanamycin stress. J Biotechnol 2009, 143(September (4)):231-238.
18. De Togni P., Fox E.S., Morrissey S., Babior B.M., Levy S.B. Spontaneous insertion of an IS2 element into the promoter region of the lac operon. Plasmid 1988, 20(September (2)):143-147.
19. European Commission, EC Guide to Good Manufacturing Practice Revision to Annex 1 Title: Manufacture of Sterile Medicinal Products Note: Manufacture of Sterile Medicinal Products; 2003.
20. Sambrook J., Fritsch E.F., Maniatis T. Molecular cloning: a laboratory manual 1989, Vol. 5, No. 1:104. Cold Spring Harbor Laboratory Press.
21. EDQM, European pharmacopeia, seventh ed.; 2010.
22. Food and Drug Administration, Points to consider in the characterization of cell lines used to produce biologicals, FDA/CBER; 1993.
23. Food and Drug Administration, Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications; December 2007.
24. Chen W., Graham C., Ciccarelli R.B. Automated fed-batch fermentation with feed-back controls based on dissolved oxygen (DO) and pH for production of DNA vaccines. J Ind Microbiol Biotechnol 1997, 18(January (1)):43-48.
25. J.A.J. Hanak, Purification of cellular components that are substantially RNA free, U.S. Patent US 6,780,632 B1 (2004).
26. Schleef M., Baier R., Walther W., Michel M.L., Schmeer M. Long-term stability study and topology analysis of plasmid DNA by capillary gel electrophoresis. BioProc Int 1996, 4(8):38-40.
27. NCBI, BLAST: Basic Lcal Alignment Search Tool; 2012. [Online]. Available: http://blast.ncbi.nlm.nih.gov/Blast.cgi.
28. Listner K., et al. Development of a highly productive and scalable plasmid DNA production platform. Biotechnol Progr 2006, 22(5):1335-1345.
29. Carnes A.E., Williams J.A. Plasmid DNA manufacturing technology. Rec Patents Biotechnol 2007, 1(2):151-166.
30. Sousa F., Queiroz J.A. Supercoiled plasmid quality assessment by analytical arginine-affinity chromatography. J Chromatogr A 2011, 1218(January (1)):124-129.
31. Prazeres D.M., Schluep T., Cooney C. Preparative purification of supercoiled plasmid DNA using anion-exchange chromatography. J Chromatogr A 1998, 806(May (1)):31-45.
32. Diogo M.M., et al. Production, purification and analysis of an experimental DNA vaccine against rabies. J Gene Med 2001, 3(6):577-584.
33. Bower D.M., Lee K.S., Ram R.J., Prather K.L.J. Fed-batch microbioreactor platform for scale down and analysis of a plasmid DNA production process. Biotechnol Bioeng 2012, 109(March (8)):1976-1986.
34. Ongkudon C.M., Ho J., Danquah M.K. Mitigating the looming vaccine crisis: production and delivery of plasmid-based vaccines. Crit Rev Biotechnol 2011, 31(March (1)):32-52.
35. Hu M., Deonier R.C. Comparison of IS1, IS2 and IS3 copy number in Escherichia coli strains K-12, B and C. Gene 1981, 16(December (1-3)):161-170.
36. D. Hanahan, Biologically pure Escherichia coli cell line which is a deoR - mutant and which is more transformation efficient with foreign plasmids than deoR+ Escherichia coli cell lines, processes for obtaining these cell lines, methods of use and thansformants there, U.S. Patent US 48513481989.
37. Prather K.L.J., Edmonds M.C., Herod J.W. Identification and characterization of IS1 transposition in plasmid amplification mutants of E. coli clones producing DNA vaccines. Appl Microbiol Biotechnol 2006, 73(December (4)):815-826.
38. Twiss E., Coros A.M., Tavakoli N.P., Derbyshire K.M. Transposition is modulated by a diverse set of host factors in Escherichia coli and is stimulated by nutritional stress. Mol Microbiol 2005, 57(September (6)):1593-1607.
39. Umenhoffer K., et al. Reduced evolvability of Escherichia coli MDS42, an IS-less cellular chassis for molecular and synthetic biology applications. Microbial Cell Factories 2010, 9(January):38.
40. Bower D.M., Prather K.L.J. Engineering of bacterial strains and vectors for the production of plasmid DNA. Appl Microbiol Biotechnol 2009, 82(April (5)):805-813.
41. Pósfai G., et al. Emergent properties of reduced-genome Escherichia coli. Science (New York, N.Y.) 2006, 312(May (5776)):1044-1046.
42. W.P. WO/2007/024,756 and 2007, Reduced Genome E. coli, http://www.wipo.int/.