Manuscripts

2012

Nellis, D., Michiel, D., Jiang, M., Esposito, D., Davis, R., Jiang, H., Korrell, A., Knapp IV, G., Lucernoni, L., Nelson, E., Pritt, E., Procter, L., Rogers, M., Sumpter, T., Vyas, V., Waybright, T., Yang, X., Zheng, A., Yovandich, J., Gilly, J., Mitra, G., and Zhu, J: Clinical Manufacturing of Recombinant Human Interleukin 15:1 Production Cell Line Development and Protein Expression in E. Coli with Stop Codon Optimization. Biotechnology Progress Journal. doi: 10.1002/btpr.746

Dobrikova, E., Goetz, C., Walters, R., Lawson, S., Peggins, J., Muszynski, K., Ruppel, S., Poole, K., Giardina, S., Vela, E., Estep J., and Gromeier, M: Attenuation of Neurovirulence, Biodistribution, and Shedding of a Poliovirus: Rhinovirus Chimera after Intrathalamic Inoculation in M. Fascicularis. Journal of Virology. 2012\J. Virol.-2012-Dobrikova-2750-9.pdf

Soman, G., Kallarakal, A., Michiel, D., Yang, X., Saptharishi, N., Jiang, N., Giardina, S., Gilly, J., and Mitra, G: Analytical characterization of ch14.18: A mouse-human chimeric disialoganglioside-specific therapeutic antibody. mAbs Journal. Published Jan 2012; http://dx.doi.org/10.4161/mabs.4.1.18566; Jan/Feb 2012, Volume 4, Issue 1, P84-100

Kim, K., Dmitriev, I., O’Malley, J.P., Wang, M., Saddekni, S., You, Z., Preuss, M.A., Harris, R.D., Aurigemma, R., Siegal, G.P., Zinn, K.R., Curiel, D.T., and Alvarez, R.D.: Ad5.SSTR/TK.RGD Phase I trial in gynecologic cancer. Clinical Cancer Research. http://clincancerres.aacrjournals.org/content/18/12/3440.long

2011

Vyas V, Dominic E, Sumpter T, Broadt T, Hartley J, Knapp IV G, Cheng W, Jiang M, Roach J, Yang X, Giardina S, Mitra G, Yovandich J, Creekmore S, Waldmann T, Zhu Z: Characterization of Recombinant Human IL-15 Deamidation and Its Practical Elimination through Substitution of Asparagine 77. Pharmaceutical Research, doi: 10.1007/s11095-011-0597-0

Soman G, Yang X, Jiang H, 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. Journal of Immunological Methods 2011.08.016, doi:10.1016

Harris R, Broadt T, Kim K, Ryan M, Estep J, Miniard B, Rudge T, Peggins J, Wang M, Preuss M, Siegal G, Hemminki A, Aurigemma R, Curiel D, Alvarez R: A new generation of serotype chimeric infectivity-enhanced conditionally replicative adenovirals: The safety profile of Ad5/3-Δ24 in advance of a Phase I clinical trial in ovarian cancer patients. Human Gene Therapy, 22:821–828, 2011.

Kimball K, Preuss M, Barnes M, Wang M, Siegal G, Wan W, Kuo H, Harris R, Aurigemma R, Curiel D, Alvarez .: A Phase I study of tropism-modified conditionally replicative adenovirus (CRAd) for recurrent gynecologic malignancies. Clin Cancer Res (November 2010).

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.


Recent Manuals, Guides and Book Chapters

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


Recent 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