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Research ArticleCONFERENCE PROCEEDING

Evaluation of A549 as a New Vaccine Cell Substrate: Digging Deeper with Massively Parallel Sequencing

Paul Shabram and John L. Kolman
PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 639-650; DOI: https://doi.org/10.5731/pdajpst.2014.01027
Paul Shabram
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References

  1. 1.↵
    1. Graham F. L.,
    2. Smiley J.,
    3. Russell W. C.,
    4. Nairn R.
    Characteristics of a human cell line transformed by DNA from human adenovirus type 5. J. Gen. Virol. 1977, 36 (1), 59–74.
    OpenUrlAbstract/FREE Full Text
  2. 2.↵
    FDA. Guidance for Industry Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications; OVRR, Ed.; FDA: Rockville, MD, 2010.
  3. 3.↵
    FDA. Cell Lines Derived from Human Tumors for Vaccine Manufacture. In VRBPAC September 2012; FDA: Silver Spring, MD, 2012.
  4. 4.↵
    1. Sheng-Fowler L.,
    2. Lewis A. M. Jr..,
    3. Peden K.
    Issues associated with residual cell-substrate DNA in viral vaccines. Biologicals 2009, 37 (3), 190–195.
    OpenUrlPubMed
  5. 5.↵
    Laboratory Animal Welfare Act, In Code of Federal Regulations, 1966.
  6. 6.↵
    1. Khan A. S.,
    2. Ma W.,
    3. Ma Y.,
    4. Kumar A.,
    5. Williams D. K.,
    6. Muller J.,
    7. Ma H.,
    8. Galvin T. A.
    Proposed algorithm to investigate latent and occult viruses in vaccine cell substrates by chemical induction. Biologicals 2009, 37 (3), 196–201.
    OpenUrlCrossRefPubMed
  7. 7.↵
    1. Giard D. J.,
    2. Aaronson S. A.,
    3. Todaro G. J.,
    4. Arnstein P.,
    5. Kersey J. H.,
    6. Dosik H.,
    7. Parks W. P.
    In vitro cultivation of human tumors: Establishment of cell lines derived from a series of solid tumors. J. Natl Cancer Inst. 1973, 51 (5), 1417–1423.
    OpenUrlAbstract/FREE Full Text
  8. 8.↵
    1. Massion P. P.,
    2. Zou Y.,
    3. Chen H.,
    4. Jiang A.,
    5. Coulson P.,
    6. Amos C. I.,
    7. Wu X.,
    8. Wistuba I.,
    9. Wei Q.,
    10. Shyr Y.,
    11. Spitz M. R.
    Smoking-related genomic signatures in non-small cell lung cancer. 2008, 178 (11), 1164–1172.
  9. 9.↵
    1. Ding L.,
    2. Getz G.,
    3. Wheeler D. A.,
    4. Mardis E. R.,
    5. McLellan M. D.,
    6. Cibulskis K.,
    7. Sougnez C.,
    8. Greulich H.,
    9. Muzny D. M.,
    10. Morgan M. B.,
    11. Fulton L.,
    12. Fulton R. S.,
    13. Zhang Q.,
    14. Wendl M. C.,
    15. Lawrence M. S.,
    16. Larson D. E.,
    17. Chen K.,
    18. Dooling D. J.,
    19. Sabo A.,
    20. Hawes A. C.,
    21. Shen H.,
    22. Jhangiani S. N.,
    23. Lewis L. R.,
    24. Hall O.,
    25. Zhu Y.,
    26. Mathew T.,
    27. Ren Y.,
    28. Yao J.,
    29. Scherer S. E.,
    30. Clerc K.,
    31. Metcalf G. A.,
    32. Ng B.,
    33. Milosavljevic A.,
    34. Gonzalez-Garay M. L.,
    35. Osborne J. R.,
    36. Meyer R.,
    37. Shi X.,
    38. Tang Y.,
    39. Koboldt D. C.,
    40. Lin L.,
    41. Abbott R.,
    42. Miner T. L.,
    43. Pohl C.,
    44. Fewell G.,
    45. Haipek C.,
    46. Schmidt H.,
    47. Dunford-Shore B. H.,
    48. Kraja A.,
    49. Crosby S. D.,
    50. Sawyer C. S.,
    51. Vickery T.,
    52. Sander S.,
    53. Robinson J.,
    54. Winckler W.,
    55. Baldwin J.,
    56. Chirieac L. R.,
    57. Dutt A.,
    58. Fennell T.,
    59. Hanna M.,
    60. Johnson B. E.,
    61. Onofrio R. C.,
    62. Thomas R. K.,
    63. Tonon G.,
    64. Weir B. A.,
    65. Zhao X.,
    66. Ziaugra L.,
    67. Zody M. C.,
    68. Giordano T.,
    69. Orringer M. B.,
    70. Roth J. A.,
    71. Spitz M. R.,
    72. Wistuba I. I.,
    73. Ozenberger B.,
    74. Good P. J.,
    75. Chang A. C.,
    76. Beer D. G.,
    77. Watson M. A.,
    78. Ladanyi M.,
    79. Broderick S.,
    80. Yoshizawa A.,
    81. Travis W. D.,
    82. Pao W.,
    83. Province M. A.,
    84. Weinstock G. M.,
    85. Varmus H. E.,
    86. Gabriel S. B.,
    87. Lander E. S.,
    88. Gibbs R. A.,
    89. Meyerson M.,
    90. Wilson R. K.
    Somatic mutations affect key pathways in lung adenocarcinoma. Nature 2008, 455 (7216), 1069–1075.
    OpenUrlCrossRefPubMedWeb of Science
  10. 10.↵
    NCI. Harms of smoking and health benefits of quitting. 2012. Available from: http://www.cancer.gov/cancertopics/factsheet/Tobacco/cessation.
  11. 11.↵
    1. Weir B. A.,
    2. Woo M. S.,
    3. Getz G.,
    4. Perner S.,
    5. Ding L.,
    6. Beroukhim R.,
    7. Lin W. M.,
    8. Province M. A.,
    9. Kraja A.,
    10. Johnson L. A.,
    11. Shah K.,
    12. Sato M.,
    13. Thomas R. K.,
    14. Barletta J. A.,
    15. Borecki I. B.,
    16. Broderick S.,
    17. Chang A. C.,
    18. Chiang D. Y.,
    19. Chirieac L. R.,
    20. Cho J.,
    21. Fujii Y.,
    22. Gazdar A. F.,
    23. Giordano T.,
    24. Greulich H.,
    25. Hanna M.,
    26. Johnson B. E.,
    27. Kris M. G.,
    28. Lash A.,
    29. Lin L.,
    30. Lindeman N.,
    31. Mardis E. R.,
    32. McPherson J. D.,
    33. Minna J. D.,
    34. Morgan M. B.,
    35. Nadel M.,
    36. Orringer M. B.,
    37. Osborne J. R.,
    38. Ozenberger B.,
    39. Ramos A. H.,
    40. Robinson J.,
    41. Roth J. A.,
    42. Rusch V.,
    43. Sasaki H.,
    44. Shepherd F.,
    45. Sougnez C.,
    46. Spitz M. R.,
    47. Tsao M. S.,
    48. Twomey D.,
    49. Verhaak R. G.,
    50. Weinstock G. M.,
    51. Wheeler D. A.,
    52. Winckler W.,
    53. Yoshizawa A.,
    54. Yu S.,
    55. Zakowski M. F.,
    56. Zhang Q.,
    57. Beer D. G.,
    58. Wistuba I. I.,
    59. Watson M. A.,
    60. Garraway L. A.,
    61. Ladanyi M.,
    62. Travis W. D.,
    63. Pao W.,
    64. Rubin M. A.,
    65. Gabriel S. B.,
    66. Gibbs R. A.,
    67. Varmus H. E.,
    68. Wilson R. K.,
    69. Lander E. S.,
    70. Meyerson M.
    Characterizing the cancer genome in lung adenocarcinoma. Nature 2007, 450 (7171), 893–898.
    OpenUrlCrossRefPubMedWeb of Science
  12. 12.↵
    1. Fukumoto S.,
    2. Yamauchi N.,
    3. Moriguchi H.,
    4. Hippo Y.,
    5. Watanabe A.,
    6. Shibahara J.,
    7. Taniguchi H.,
    8. Ishikawa S.,
    9. Ito H.,
    10. Yamamoto S.,
    11. Iwanari H.,
    12. Hironaka M.,
    13. Ishikawa Y.,
    14. Niki T.,
    15. Sohara Y.,
    16. Kodama T.,
    17. Nishimura M.,
    18. Fukayama M.,
    19. Dosaka-Akita H.,
    20. Aburatani H.
    Overexpression of the aldo-keto reductase family protein AKR1B10 is highly correlated with smokers' non-small cell lung carcinomas. Clin. Cancer Res. 2005, 11 (5), 1776–1185.
    OpenUrlAbstract/FREE Full Text
  13. 13.↵
    1. Rodriguez-Nieto S.,
    2. Sanchez-Cespedes M.
    BRG1 and LKB1: tales of two tumor suppressor genes on chromosome 19p and lung cancer. Carcinogenesis 2009, 30 (4), 547–554.
    OpenUrlAbstract/FREE Full Text
  14. 14.↵
    1. Wingo S. N.,
    2. Gallardo T. D.,
    3. Akbay E. A.,
    4. Liang M. C.,
    5. Contreras C. M.,
    6. Boren T.,
    7. Shimamura T.,
    8. Miller D. S.,
    9. Sharpless N. E.,
    10. Bardeesy N.,
    11. Kwiatkowski D. J.,
    12. Schorge J. O.,
    13. Wong K. K.,
    14. Castrillon D. H.
    Somatic LKB1 mutations promote cervical cancer progression. PLoS ONE 2009, 4 (4), 5137.
    OpenUrl
  15. 15.↵
    1. Rudin C. M.,
    2. Avila-Tang E.,
    3. Harris C. C.,
    4. Herman J. G.,
    5. Hirsch F. R.,
    6. Pao W.,
    7. Schwartz A. G.,
    8. Vahakangas K. H.,
    9. Samet J. M.
    Lung cancer in never smokers: molecular profiles and therapeutic implications. Clin. Cancer Res. 2009, 15 (18), 5646–5461.
    OpenUrlAbstract/FREE Full Text
  16. 16.↵
    Welcome Trust Sanger Institute. NCI-60 Cancer Gene Cell Line Project. 2012. Available at: http://www.sanger.ac.uk/perl/genetics/CGP/core_line_viewer?action=sample&id=905949.
  17. 17.↵
    Wellcome Trust Sanger Institute database of somatic mutation information in human cancers. 2012.
  18. 18.↵
    1. Loeb K. A.,
    2. Loeb L. A.
    Significance of multiple mutations in cancer. Carcinogenesis 2000, 21 (3), 379–385.
    OpenUrlAbstract/FREE Full Text
  19. 19.↵
    1. Frisch S. M.
    Anoikis. Methods Enzymol. 2000, 322, 472–479.
    OpenUrlPubMedWeb of Science
  20. 20.↵
    1. Feng H.,
    2. Shuda M.,
    3. Chang Y.,
    4. Moore P. S.
    Clonal integration of a polyomavirus in human Merkel cell carcinoma. Science 2008, 319 (5866), 1096–1100.
    OpenUrlAbstract/FREE Full Text
  21. 21.↵
    1. Chuck A. S.,
    2. Clarke M. F.,
    3. Palsson B. O.
    Retroviral infection is limited by Brownian motion. Hum Gene Ther. 1996, 7 (13), 1527–1534.
    OpenUrlCrossRefPubMedWeb of Science
  22. 22.↵
    1. Curiel D.,
    2. Douglas J.
    1. Evans J.,
    2. Hearing P.
    Adenovirus Replication. In Adenoviral Vectors for Gene Thereapy, Curiel D., Douglas J. , Eds.; Academic Press: San Diego, CA, 2002.
  23. 23.↵
    1. Gu J.,
    2. Zhang L.,
    3. Swisher S. G.,
    4. Liu J.,
    5. Roth J. A.,
    6. Fang B.
    Induction of p53-regulated genes in lung cancer cells: implications of the mechanism for adenoviral p53-mediated apoptosis. Oncogene 2004, 23 (6), 1300–1307.
    OpenUrlCrossRefPubMed
  24. 24.↵
    1. Onions D.,
    2. Kolman J.
    Massively parallel sequencing, a new method for detecting adventitious agents. Biologicals 2010, 38 (3), 377–380.
    OpenUrlPubMed
  25. 25.↵
    1. Kolman J.
    Personal communication, 2013.
  26. 26.↵
    1. Souza T. A.,
    2. Stollar B. D.,
    3. Sullivan J. L.,
    4. Luzuriaga K.,
    5. Thorley-Lawson D. A.
    Influence of EBV on the peripheral blood memory B cell compartment. J. Immunol. 2007, 179 (5), 3153–3160.
    OpenUrlAbstract/FREE Full Text
  27. 27.↵
    1. Minarovits J.
    Epigenotypes of latent herpesvirus genomes. Curr. Top. Microbiol. Immunol. 2006, 310, 61–80.
    OpenUrlPubMedWeb of Science
  28. 28.↵
    1. Mayall T.
    A novel cell substrate enabling production of new vaccine candidates. 2012. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM325115.pptx.
  29. 29.↵
    FDA. Summary Minutes Vaccines and Related Biological Products Advisory Committee September 19, 2012, in Vaccine and Realted Biological Products Advisory Products Committee Meeting September 2012. FDA: Silver Spring, MD, 2012.
  30. 30.↵
    1. Skloot R.
    The Immortal Life of Henrietta Lacks; Broadway Paperbacks: New York, 2011; p 381.
  31. 31.↵
    1. Peden K.,
    2. Sheng L.,
    3. Pal A.,
    4. Lewis A.
    Biological activity of residual cell-substrate DNA. Dev. Biol. (Basel) 2006, 123, 45–53, discussion 55–73.
    OpenUrlPubMed
  32. 32.↵
    FDA. FDA Briefing Document, Sept 19, 2012.
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PDA Journal of Pharmaceutical Science and Technology: 68 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 6
November/December 2014
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Evaluation of A549 as a New Vaccine Cell Substrate: Digging Deeper with Massively Parallel Sequencing
Paul Shabram, John L. Kolman
PDA Journal of Pharmaceutical Science and Technology Nov 2014, 68 (6) 639-650; DOI: 10.5731/pdajpst.2014.01027

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Evaluation of A549 as a New Vaccine Cell Substrate: Digging Deeper with Massively Parallel Sequencing
Paul Shabram, John L. Kolman
PDA Journal of Pharmaceutical Science and Technology Nov 2014, 68 (6) 639-650; DOI: 10.5731/pdajpst.2014.01027
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  • Article
    • Abstract
    • Introduction
    • MPS Method
    • Identification of Viral Sequences and Interpretation of Results
    • The A549 Transformation Event
    • Induction of Somatic Cancer Gene Defects By Environmental Factors Versus Perturbation By Viruses
    • A549 Release Testing and Characterization
    • MPS Assessment of Viruses Within A549 Cells
    • September 2012 VRBPAC
    • Discussion
    • Acknowledgements
    • Footnotes
    • References
  • Figures & Data
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  • References
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CONFERENCE PROCEEDING

  • Proceedings of the 2017 Viral Clearance Symposium: Conclusion
  • Proceedings of the 2017 Viral Clearance Symposium, Session 1.2: Upstream Mitigation, Part 2—Virus Barrier Filter and HTST
  • Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
Show more CONFERENCE PROCEEDING

Applications on New Analytical Technologies

  • Proceedings of the 2017 Viral Clearance Symposium: Conclusion
  • Proceedings of the 2017 Viral Clearance Symposium, Session 1.2: Upstream Mitigation, Part 2—Virus Barrier Filter and HTST
  • Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
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