Recent BDP Publications

Manuscripts

  • 2015

    Jiang MS, Yang XY, Esposito D, Nelson E, Yuan JH, Hopkins RF, Broadt T, Xiao Z, Colantonio S, Prieto DA, Welch AR, Creekmore SP, Mitra G, Zhu JW: Mammalian cell transient expression, non-affinity purification, and characterization of human recombinant IGFBP7, an IGF-1 targeting therapeutic protein. Int. Immunopharmacol., 29(2):476-487, 2015. doi:10.1016/j.intimp.2015.10.008.

    http://www.sciencedirect.com/science/article/pii/S1567576915301417 http://www.ncbi.nlm.nih.gov/pubmed/26474694

    Cronin M, Coolbaugh MJ, Nellis D, Zhu JW, Wood DW, Nussinov R, Ma BY: Dynamics differentiate between active and inactive inteins. Eur. J. Chem., 91:51-62, 2015. doi:10.1016/j.ejmech.2014.07.094, PMCID:PMC4308580.

    http://www.sciencedirect.com/science/article/pii/S0223523414007090 http://www.ncbi.nlm.nih.gov/pubmed/25087201
  • 2014

    Zustiak MP, Jose L, Xie YQ, Zhu JW, Betenbaugh MJ: Enhanced transient recombinant protein production in CHO cells through the co-transfection of the product gene with Bcl-x(L). Biotechnol. J., 9(9):1164-1174, 2014. doi:10.1002/biot.201300468, PMCID:PMC4219531.

    http://onlinelibrary.wiley.com/doi/10.1002/biot.201300468/full http://www.ncbi.nlm.nih.gov/pubmed/24604826
  • 2013

    Yang XY, Kallarakal A, Saptharishi N, Jiang HG, Yang ZW, Xie YQ, Mitra G, Zheng XX, Strom TB, Soman G: Molecular Characterization and Functional Activity of an IL-15 Antagonist MutIL-15/Fc Human Fusion Protein. Mol. Pharm., 10(2):717-727, 2013. doi:10.1021/mp300513j, PMCID:PMC3573692.

    http://pubs.acs.org/doi/full/10.1021/mp300513j http://www.ncbi.nlm.nih.gov/pubmed/23311475

    Rahman A, Rahman AK, Ruby D, Broadt T: Terahertz spectroscopic characterization of protein vaccine antigens and saponin-derived adjuvant macromolecules. Abstracts of Papers of the American Chemical Society, 246, 2013.

    Jiang H, Xie Y, Burnette A, Roach J, Giardina SL, Hecht TT, Creekmore SP, Mitra G, Zhu J: Purification of clinical-grade disulfide stabilized antibody fragment variable--Pseudomonas exotoxin conjugate (dsFv-PE38) expressed in Escherichia coli. Appl. Microbiol. Biotechnol., 97(2):621-632, 2013. doi:10.1007/s00253-012-4319-2.

    http://link.springer.com/article/10.1007/s00253-012-4319-2/fulltext.html http://www.ncbi.nlm.nih.gov/pubmed/22890777
  • 2012

    Zhu JW: Mammalian cell protein expression for biopharmaceutical production. Biotechnol. Adv., 30(5):1158-1170, 2012. doi:10.1016/j.biotechadv.2011.08.022, PMCID.

    http://www.sciencedirect.com/science/article/pii/S0734975011001674 http://www.ncbi.nlm.nih.gov/pubmed/21968146

    Vyas VV, Esposito D, Sumpter TL, Broadt TL, Hartley J, Knapp GC, Cheng W, Jiang MS, Roach JM, Yang XY, Giardina SL, Mitra G, Yovandich JL, Creekmore SP, Waldmann TA, Zhu JW: Clinical manufacturing of recombinant human interleukin 15. I. Production cell line development and protein expression in E. coli with stop codon optimization. Biotechnol. Prog., 28(2):497-507, 2012. doi:10.1002/btpr.746.

    http://onlinelibrary.wiley.com/doi/10.1002/btpr.746/full http://www.ncbi.nlm.nih.gov/pubmed/22162520

    Soman G, Kallarakal AT, Michiel D, Yang XY, Saptharishi N, Jiang HG, Giardina S, Gilly J, Mitra G: Analytical characterization of ch14.18 A mouse-human chimeric disialoganglioside-specific therapeutic antibody. Mabs, 4(1):84-100, 2012. doi:10.4161/mabs.4.1.18566, PMCID:PMC3338943.

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3338943/pdf/mabs0401_0084.pdf http://www.ncbi.nlm.nih.gov/pubmed/22327432

    Nellis DF, Michiel DF, Jiang MS, Esposito D, Davis R, Jiang HG, Korrell A, Knapp GC, Lucernoni LE, Nelson RE, Pritt EM, Procter LV, Rogers M, Sumpter TL, Vyas VV, Waybright TJ, Yang XY, Zheng AM, Yovandich JL, Gilly JA, Mitra G, Zhu JW: Characterization of Recombinant Human IL-15 Deamidation and Its Practical Elimination through Substitution of Asparagine 77. Pharm. Res., 29(3):722-738, 2012. doi:10.1007/s11095-011-0597-0.

    http://link.springer.com/article/10.1007/s11095-011-0597-0/fulltext.html http://www.ncbi.nlm.nih.gov/pubmed/22009587

    Dobrikova EY, Goetz C, Walters RW, Lawson SK, Peggins JO, Muszynski K, Ruppel S, Poole K, Giardina SL, Vela EM, Estep JE, Gromeier M: Attenuation of Neurovirulence, Biodistribution, and Shedding of a Poliovirus:Rhinovirus Chimera after Intrathalamic Inoculation in Macaca fascicularis. J. Virol., 86(5):2750-2759, 2012. doi:10.1128/jvi.06427-11, PMCID:PMC3302279.

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3302279/pdf/zjv2750.pdf http://www.ncbi.nlm.nih.gov/pubmed/22171271
  • 2011

    Soman G, Yang XY, Jiang HG, Giardina S, Mitra G: Comparison of GD2 binding capture ELISA assays for anti-GD2-antibodies using GD2-coated plates and a GD2-expressing cell-based ELISA. J. Immunol. Methods., 373(1-2):181-191, 2011. doi:10.1016/j.jim.2011.08.016, PMCID:PMC3196293.

    http://www.sciencedirect.com/science/article/pii/S0022175911002213 http://www.ncbi.nlm.nih.gov/pubmed/21893062

    Kim KH, Ryan MJ, Estep JE, Miniard BM, Rudge TL, Peggins JO, Broadt TL, Wang MH, Preuss MA, Siegal GP, Hemminki A, Harris RD, Aurigemma R, Curiel DT, Alvarez RD: A New Generation of Serotype Chimeric Infectivity-Enhanced Conditionally Replicative Adenovirals: The Safety Profile of Ad5/3-Delta 24 in Advance of a Phase I Clinical Trial in Ovarian Cancer Patients. Hum. Gene Ther., 22(7):821-828, 2011. doi:10.1089/hum.2010.180, PMCID.

    http://online.liebertpub.com/doi/full/10.1089/hum.2010.180 http://www.ncbi.nlm.nih.gov/pubmed/21171861

    Han KP, Zhu XY, Liu B, Jeng E, Kong L, Yovandich JL, Vyas VV, Marcus WD, Chavaillaz PA, Romero CA, Rhode PR, Wong HC: IL-15:IL-15 receptor alpha superagonist complex: High-level co-expression in recombinant mammalian cells, purification and characterization. Cytokine, 56(3):804-810, 2011. doi:10.1016/j.cyto.2011.09.028, PMCID: PMC3221918.

    http://www.sciencedirect.com/science/article/pii/S1043466611007642 http://www.ncbi.nlm.nih.gov/pubmed/22019703

    Broadt TL: Terahertz spectrometry and identification of well characterized organic and biological compounds. Abstracts of Papers of the American Chemical Society, 242, 2011.

  • Pre-2011

    Kenneth H. Kim1, Patricia J. Tosca3, John W. Merrill3, Michael Ryan3, James E. Estep3, Brock M. Miniard3, Thomas L. Rudge3, James O. Peggins2, Trevor L. Broadt4, Minghui Wang5, Meredith A. Preuss5, Gene P. Siegal6, Akseli Hemminki7, Raymond D. Harris8, Rosemarie Aurigemma9, David T. Curiel5, Ronald D. Alvarez1: The First in a New Generation of Serotype Chimeric Infectivity-Enhanced CRAds: Identifying the Safety Profile of Ad5/3-Δ24 in Anticipation of a Phase I Clinical Trial in Patients with Ovarian Cancer. Cancer Research. In Press 2010.

    Soman G, Yang XY, Jiang H, Giardina S, Vyas V, Mitra G, Yovandich J Creekmore SP, Waldmann TA, Quiñones O, Alvord WG:  MTS dye-based colorimetric CTLL-2 cell proliferation assay for product release and stability monitoring of Interleukin-15: Assay qualification, standardization, and statistical analysis. J Immunol Methods 2009, 348: 83-94.

    Matthews, K., Noker, P., Tian, B., Grimes, S., Fulton, R.,Schweikart, Karen, Harris, Ray, Aurigemma, Rose, Wang, M., Barnes, M., Siegal, G., Hemminki, A., Zinn, K., Curiel, D., Alvarez, R., Identifying the Safety Profile of Ad5.SSTR/TK.RGD, a Novel Infectivity-Enhanced Bicistronic Adenovirus, in Anticipation of a Phase I Clinical Trial in Patients with Recurrent Ovarian Cancer, Clinical Cancer Research 15:4131-4137 2009

    Gopalan*, Saptharishi, Nirmala, Yang, Xiaoyi, Mancini, Luke, Giardina, Steve L., Vyas, Vinay, Gilly, John, Yovandich, Jason, Stephen P. Creekmore and George Mitra, (2009) Protein Conformation and Biochemical Stability of Recombinant Human IL-15 Expressed in E.coli., Elsevier

    Soman, Gopalan, Yang Xiaoyi, Jiang, Hengguang, Giardina, Steve L., Vyas, Vinay, Mitra, George, Yovandich, J., Creekmore , S.P., A. Waldmann, T.A., Quiñones, O., Alvord W, G (2009) MTS dye based colorimetric CTLL-2 cell proliferation assay for product release and stability monitoring of Interleukin-15: Assay qualification, standardization and statistical analysis, J. Immunol. Methods (In press).

    Yang Xiaoyi, Chen, E., Jiang, Hengguang, Muszynski, K., Harris, Ray, Giardina Steve, Gromeier M., Mitra, George, Soman, Gopalan, (2009) Evaluation of IRES-mediated cell type-specific cytotoxicity of poliovirus using a colorimetric cell proliferation assay. Journal of Virological Methods. 155:44-54

    Dobrikova E.Y., Broadt Trevor., Poiley-Nelson Judy., Yang Xiaoyi, Soman Gopalan, Giardina Steve, Harris R., Gromeier M., (2008) Recombinant oncolytic poliovirus eliminates glioma in vivo without genetic adaptation to a pathogenic phenotype. Molecular Therapy 16:1865-1872.

    Matthrews, K., Noker, P.E., Tian, B., Grimes, D., Fulton, R., Schweikart, K., Harris, Ray, Aurigemma, R., Wang, M., Barnes, M.N., Siegal, G.P., Hemminki, A., Zinn, K., Curiel, D.T., Alvarex, R.D., (2008) The Safety Profile of Ad5.SSTR/TK.RGD, an Infectivity-Enhanced Bicistronic Adenovirus, in Anticipation of a Phase 1 Clinical Trial in Recurrent Ovarian Cancer, Clinical Cancer Research (transfer to American Association for Cancer Research)

    Dobrikova E.Y., Broadt, Trevor, Poiley-Nelson, Judy, Yang,Xiaoyi, Soman, Gopalan, Giardina Steve L., Harris, Ray, Gromeier M., (2008) Recombinant oncolytic poliovirus eliminates glioma in vivo without genetic adaptation to a pathogenic phenotype. Molecular Therapy 16:1865-1872.


Manuals, Guides and Book Chapters

  • Pre-2011

    Nellis, David, Michiel, Dennis: Chapter on Good Manufacturing Practices: Good Manufacturing Practices, The Encyclopedic Reference of Cancer (Second Edition 2009).

    http://www.springer.com/biomed/cancer/book/978-3-540-36847-2

    Michiel, Dennis: Chapter on Good Laboratory Practices: Good Laboratory Practices, The Encyclopedic Reference of Cancer (Second Edition 2009).

    http://www.springer.com/biomed/cancer/book/978-3-540-36847-2

    Laurencot C, Ruppel S.: Chapter on Regulatory Aspects for Translating Gene Therapy Research into the Clinic, Gene Therapy of Cancer: Methods and Protocols, (Second Edition, Edited by Wolfgang Walther and Ulrike Stein, March 2009; 452: pgs 395-419).


Abstracts/Presentations

  • 2012

    Broadt, T.: “The Biopharmaceutical Development Program at the ATRF.” Hagerstown Community College, Maryland Biology Teachers Seminar. June 29, 2012.

    Broadt, T. and Gaum, D.: “The Biopharmaceutical Development Program at the ATRF.” Hagerstown Community College Biomanufacturing class. April 17, 2012.

    Broadt, T. and Gaum, D.: “The Biopharmaceutical Development Program at the ATRF.” Stevenson University Biotechnology class. April 18, 2012.

    D' Souza, D., Ruppel, M., and Ruby, D.: Characterization of Recombinant HPV16 L2E6E7 Fusion Protein Using Analytical Methods. FNLCR Summer Student Abstract and Poster. August 1, 2012.

    Gaum, D.: “The Biopharmaceutical Development Program at the ATRF.” FCC Bioprocessing Program Students. May 1, 2012

    Ruppel, S. and Mitra, G.: SAIC Capabilities Showcase Event Poster, April 2012 Leadership Week, April 16, 2012

    Zhu, J.: Auantitation of Monophosphorylated Lipid-A in the Oil-in-Water Adjuvant Vaccine Delivery System Using Transesterification and GM-MS. Annual CCR and DCEG staff clinician retreat held in Bethesda, MD. April 17, 2012.

    Zhu, J.: Preparation, Testing, and Stability Assessment of Vaccine Adjuvant Monophophory Lipid A. FNLCR Spring Research Festival, held at Ft. Detrick. May 9–10, 2012.

    Zhu, J.: Rapid Delivery of Recombinant Protein Using Transient Gene Expression Technology for Pre-clinical Assessment. FNLCR Spring Research Festival, held at Ft. Detrick. May 9–10, 2012.

  • 2011

    Giardina S.: Comparability of multiple lots of a chimeric monoclonal antibody manufactured on a ten-year period. 14th Annual IBC Well-Characterized Biologicals Conference, Bethesda, MD. October 21–22, 2010.

    Zhu J: Recombinant protein production by mammalian cells. Department of Science, Mount St. Mary’s University, Emmitsburg, PA. October 22, 2010.

    Zustiak M: Cell cycle arrest engineering to enhance production phase in CHO cell culture. AIChE Annual Meeting, Salt Lake City, UT. November 8, 2010.

    Koleck M: Career talk; promoting science to 8th graders at California Area School, California, PA. November 8, 2010.

    Ruby D, Abedinpour F, Michiel D, Koleck M, Giardina S: Analytical methods for characterization of Ch14.18 monoclonal antibody poster. NCI-Frederick-Fort Detrick Spring Research Festival. April 27–28, 2011.

  • Pre-2011

    Koleck, M: Career Talk; Promoting Science to 8th Graders. California Area Middle School; Science Day, California, PA. November 24, 2010

    Zustiak, M; Cell Cycle Arrest Engineering to Enhance Production Phase in CHO Cell Culture. AIChE Conference, Salt Lake City, UT. November 8, 2010

    Zhu, J: Recombinant Protein Production by Mammalian Cells. Department of Science, Mount St. Mary’s University. October 22, 2010

    Giardina, S: Ch14.18 Comparability, 14th Annual IBC Well-Characterized Biologicals Conference. Bethesda, MD October 21-22, 2010

    Zhu, J; Proten Production in Mammalian System. American Society for Microbiology (ASM), San Diego, CA, May 24-25, 2010

    Alvarez RD, Aurigemma R, Barnes MN, Curiel DT, Harris R, Kimball KJ, Preuss MA, Siegal GP, Wan W, Wang M: A phase I clinical trial of Ad5.SSTR/TK.RGD, a novel infectivity-enhanced bicistronic adenovirus, in patients with recurrent gynecologic cancer. American Chemical Society Annual Conference, 2010.

    Gilly, J: Darwin, God, Literature and History; A Panel Discussion, Celebrating 150 Years of Darwin’s Origin of Species. Mount St. Mary’s University, Emmitsburg, MD. November 11, 2010.

    Gilly, J: Biology and Clinical Prospects of Interleukin-15. National Cancer Institute, Frederick, MD. October 28, 2010.

    Gilly, J; Risk-based compliance for production of agents for phase 0 studies. Translational Cancer Medicine, Washington, DC, September 23, 2009.

    Jiang, M.S: Purification of Recombinant Human Interleukin-15 by Preparative Reversed Phase Chromatography for Clinical Manufacturing. ACS-BIOT Conference, Washington DC. August 18, 2009

    Vyas, V: Challenges to +Process Development of rhIL-15 from Escherichia coli; RP-HPLC as a tool for Process Analytical Technology. ACS-BIOT Conference, Washington DC. August 18, 2009

    Soman, G: Protein Conformation and Biochemical Stability of Recombinant Human IL-15 Expressed in E. coli. ACS-BIOT Conference, Washington DC. August 18, 2009

    Gilly, J: Risk Based Compliance for Production of Agents for Phase 0 Studies. Translation Center Medicine, San Diego, CA. January 27, 2009

    Mitra, G: Bringing Biologics to Human Clinical Trails at the Biopharmaceutical Development Program (BDP – Accomplishments and Challenges. DARPA Accelerated Manufacture of Pharmaceuticals (AMP) Phase II Program Review; Keystone, CO November 6 – 7, 2008

    Gilly, J: Biopharmaceutical Development at National Cancer Institute. Cambridge Healthtech Institutes (CHI) Inagural Accelerating Proof-of-Concept Conference; Boston, MA. October 8, 2008

    Dennis F. Michiel, David F. Nellis, Man-Shiow Jiang, Terry L. Sumpter, George C. Knapp IV, Xiaoyi Yang, Gopalan Soman, Vinay V. Vyas, Jianwei Zhu, Jason Yovandich, Liyanage P. Perera, Thomas A. Waldmann, George Mitra; Evaluation of Process Modifications to Support GMP Production of Recombinant Human Interleukin-15 for Clinical Trails. Cancer Immunology and Immunotherapy; Realizing the Promise Conference, Bethesda, MD. September 11 – 12, 2008.

    Vinay Vyas, Man-Shiow Jiang, Xiaoyi Yang, Terry Sumpter, Trevor Broadt, Andrew Burnette, John Roach, Gopalan Soman, Dennis Michiel, Jianwei Zhu, Steven Giardina, John Gilly, Jason Yovandich, Steve Creekmore, Liyanage. P. Perera, Thomas A. Waldmann, George Mitra; Process for the Clinical Manufacture of Recombinant Human Interleukin-15 from Escherichia coli. Cancer Immunology and Immunotherapy; Realizing the Promise Conference, Bethesda, MD. September 11 – 12, 2008.

    Gilly, J: The Crucial Role of Translational Medicine in Drug Development – The BDP at the National Cancer Institute at Frederick. BIO2008, Sand Diego, CA June 17 – 18, 2008.

    Kristopher Kimball, Michael T. Numnum, Mack N. Barnes, Sharmila Makhija, Minghui Wang, Gene P. Siegal, Ray Harris, Rose Aurigemma, Ronald D. Alvarez; A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus (CRAd) for Recurrent Ovarian Cancer. ASGT 11th Annual Meeting, Boston, MA. May 28 – June 1, 2008.

    Giardina, S., Gilly, J., Mitra, G: Bench to Bedside: The Biopharmaceutical Development Program. 2008 NCI Intramural Scientific Retreat, Bethesda, MD. January 8, 2008.

    Jianwei Zhu, Yueqing Xie, Vinay V Vyas, Beverly Keseling, John Roach, George Mitra, Stephen P. Creekmore: Rapid development of mammalian cell production process of clinical material for proof-of-principle of novel therapeutic molecules. 2008 NCI Intramural Scientific Retreat, Bethesda, MD. January 8, 2008.

    Poon, D., Jendrek, S., Harris, R: Manufacture of a Replication-Selective and Enhanced-Lytic Adenovirus Vector. 2008 NCI Intramural Scientific Retreat, Bethesda, MD. January 8, 2008.

    Zhu, Jianwei: Strategy and execution of clinical material delivery for safety assessment and proof of principle of novel therapeutic molecules. Ahejiang Hi Sun Pharmaceuticals, Corp. Ltd, Shanghai City and Zhejiang Province of China, May 20, 2008

    Various Authors. Biopharmaceutical Development Program's Progress on USAMRIID's Vaccines for Biological Warfare Agents