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