Publications

Complete Publications List - Macromolecule and Vaccine Stabilization Center

PubMed Articles for MVSC Directors:

CR Middaugh | DB Volkin | SB Joshi

Selected Publications Since 2001 from the MVSC:

2017

  • Arora J, Joshi SB, Middaugh CR, Weis DD, Volkin DB,“Correlating the effects of antimicrobial preservatives on conformational stability, aggregation propensity, and backbone flexibility of an IgG1 monoclonal antibody” J Pharm Sci (In Press 2017).
  • Sahni N, Chaudhuri R, Hickey JM, Manikwar P, D'Souza A, Metters A, Joshi SB, Middaugh CR, Volkin DB, “Preformulation characterization, stabilization and formulation design for the acrylodan-labeled glucose binding protein SM4-AC” J Pharm Sci. (In Press 2017)
  • Hickey JM, Sahni N, Chaudhuri R, D'Souza A, Metters A, Joshi SB, Russell Middaugh CR, Volkin DB, “Effect of acrylodan conjugation and forced oxidation on the structural integrity, conformational stability and binding activity of a glucose binding protein SM4 used in a prototype continuous glucose monitor” Protein Sci 126(3): 527-535 (2017).

2016

  • Arora J, Hu Y, Esfandiary R, Sathish HA, Bishop SM, Joshi SB, Middaugh CR, Volkin DB, Weis DD. Charge-mediated Fab-Fc interactions in an IgG1 antibody induce reversible self-association, cluster formation, and elevated viscosity." MAbs  8(8):1561-1574 (2016).
  • Toprani VM, Joshi SB, Kueltzo LA, Schwartz RM, Middaugh CR, Volkin DB. A Micro-Polyethylene Glycol Precipitation Assay as a Relative Solubility Screening  Tool for Monoclonal Antibody Design and Formulation Development. J Pharm Sci. 2016 Aug;105(8):2319-27.
  • Kalonia C, Toprani V, Toth RT, Wahome N, Gabel I, Middaugh CR, Volkin DB. Effects of Protein Conformation, Apparent Solubility, and Protein-Protein Interactions on the Rates and Mechanisms of Aggregation for an IgG1 Monoclonal Antibody. J Phys Chem B. J Phys Chem B. 120(29):7062-75 (2016).
  • Wahome N, Cooper A, Thapa P, Choudhari S, Gao FP, Volkin DB, Middaugh CR.Production of Well-Characterized Virus-like Particles in an Escherichiacoli-Based Expression Platform for Preclinical Vaccine Assessments. Methods Mol Biol. 2016;1404:437-57
  • Wahome N, Hickey JM, Volkin DB, Middaugh CR. Formulation Studies During Preclinical Development of Influenza Hemagglutinin and Virus-Like ParticleVaccine Candidates. Methods Mol Biol. 2016;1404:393-421.
  • Hickey JM, Sahni N, Toth RT 4th, Kumru OS, Joshi SB, Middaugh CR, Volkin DB.Challenges and opportunities of using liquid chromatography and mass spectrometrymethods to develop complex vaccine antigens as pharmaceutical dosage forms. J Chromatogr B Analyt Technol Biomed Life Sci. J. Chromatogr. B 1032: 23-38 (2016).
  • Ghazvini S, Kalonia C, Volkin DB, Dhar P. Evaluating the Role of the Air-Solution Interface on the Mechanism of Subvisible Particle Formation Caused by Mechanical Agitation for an IgG1 mAb. J Pharm Sci. 2016 May;105(5):1643-56.
  • Wahome N ,Sully E,Singer V, Thomas JC, Hu L, Joshi SB, Volkin DB, Fang J, Karanicolas J, Jacobs DJ, Mantis NJ, Middaugh CR. Novel Ricin Subunit Antigens With Enhanced Capacity to Elicit Toxin-Neutralizing Antibody Responses in Mice. J Pharm Sci. 2016 May;105(5):1603-13.
  • Mozziconacci O, Arora J, Toth Iv RT, Joshi SB, Zhou S, Volkin DB, Schoneich C. Site-specific hydrolysis reaction C-terminal of methionine in Met-His during metal-catalyzed oxidation of IgG-1. Mol Pharm. 2016 Apr 4;13(4):1317-28.
  • Kim JH, Joshi SB, Esfandiary R, Iyer V, Bishop SM, Volkin DB, Middaugh CR. Improved Comparative Signature Diagrams to Evaluate Similarity of StorageStability Profiles of Different IgG1 mAbs. J Pharm Sci. 2016 Mar;105(3):1028-35.
  • Kim JH, Joshi SB, Tolbert TJ, Middaugh CR, Volkin DB, Smalter Hall A. Biosimilarity Assessments of Model IgG1-Fc Glycoforms Using a Machine Learning Approach. J Pharm Sci. 2016 Feb;105(2):602-12.
  • More AS, Toprani VM, Okbazghi SZ, Kim JH, Joshi SB, Middaugh CR, Tolbert TJ, Volkin DB. Correlating the Impact of Well-Defined Oligosaccharide Structures on Physical Stability Profiles of IgG1-Fc Glycoforms. J Pharm Sci. 2016 Feb;105(2):588-601.
  • Mozziconacci O, Okbazghi S, More AS, Volkin DB, Tolbert T, Schöneich C. Comparative Evaluation of the Chemical Stability of 4 Well-Defined Immunoglobulin G1-Fc Glycoforms. J Pharm Sci. 2016 Feb;105(2):575-87.
  • Okbazghi SZ, More AS, White DR, Duan S, Shah IS, Joshi SB, Middaugh CR, Volkin DB, Tolbert TJ. Production, Characterization, and Biological Evaluation of Well-Defined IgG1 Fc Glycoforms as a Model System for Biosimilarity Analysis. J Pharm Sci. 2016 Feb;105(2):559-74.

2015

  • Jain NK, Sahni N, Kumru OS, Joshi SB, Volkin DB, Middaugh CR. Formulation and Stabilization of Recombinant Protein Based Virus-like Particle Vaccines. Advanced Drug Delivery Reviews.  2015 Oct 1;93:42-55.
  • Arora J, Hickey JM, Majumdar R, Esfandiary R, Bishop SM, Samra HS, MiddaughCR, Weis DD, Volkin DB. Hydrogen Exchange Mass Spectrometry Reveals Protein Interfaces and Distant Dynamic Coupling Effects During the Reversible Self-Association of An IgG1 Monoclonal Antibody. MAbs. 2015;7(3):525-39.
  • Telikepalli S, Shinogle HE, Thapa PS, Kim JH, Deshpande M, Jawa V, MiddaughCR, Narhi LO, Joubert MK, Volkin DB. Physical Characterization and In Vitro Biological Impact of Highly Aggregated Antibodies Separated into Size-Enriched Populations by Fluorescence-Activated Cell Sorting. J Pharm Sci. 2015 May;104(5):1575-91.
  • Hassett KJ, Vance DJ, Jain NK, Sahni N, Rabia LA, Cousins MC, Joshi S, Volkin  DB, Middaugh CR, Mantis NJ, Carpenter JF, Randolph TW. Glassy-state stabilization of a dominant negative inhibitor anthrax vaccine containing aluminum hydroxide and glycopyranoside lipid a adjuvants. J Pharm Sci. 2015 Feb;104(2):627-39.
  • Majumdar R, Esfandiary R, Bishop SM, Samra HS, Middaugh CR, Volkin DB, Weis DD. Correlations between changes in conformational dynamics and physical stability in a mutant IgG1 mAb engineered for extended serum half-life. MAbs. 2015 Jan 2;7(1):84-95
  • Telikepalli S, Kumru OS, Kim JH, Joshi SB, O'Berry KB, Blake-Haskins AW, Perkins MD, Middaugh CR, Volkin DB. Characterization of the Physical Stability of a Lyophilized IgG1 mAb after Accelerated Shipping-Like Stress. J Pharm Sci. 2015  Feb;104(2):495-507.
  • Volkin DB, Hershenson S, Ho RJ, Uchiyama S, Winter G, Carpenter JF. Two decades of publishing excellence in pharmaceutical biotechnology. J Pharm Sci. 2015 Feb;104(2):290-300
  • Kumru OS, Joshi SB, Thapa P, Pheasey N, Bullock PS, Bashiri H, Siska CS, Kerwin BA, He F, Volkin DB, Middaugh CR. Characterization of an oncolytic herpes  simplex virus drug candidate. J Pharm Sci. 2015 Feb;104(2):485-94.
  • Majumdar R, Middaugh CR, Weis DD, Volkin DB. Hydrogen-deuterium exchange mass  spectrometry as an emerging analytical tool for stabilization and formulation development of therapeutic monoclonal antibodies. J Pharm Sci. 2015 Feb;104(2):327-45
  • Kalonia C, Kumru OS, Prajapati I, Mathaes R, Engert J, Zhou S, Middaugh CR, Volkin DB. Calculating the mass of subvisible protein particles with improved accuracy using microflow imaging data. J Pharm Sci. 2015 Feb;104(2):536-47.

2014

  • Naik S, Kumru OS, Cullom M, Telikepalli SN, Lindboe E, Roop TL, Joshi SB, Amin D, Gao P, Middaugh CR, Volkin DB, Fisher MT. Probing structurally altered andaggregated states of therapeutically relevant proteins using GroEL coupled to bio-layer Interferometry. Protein Sci. 2014 Oct;23(10):1461-78.
  • Kumru OS, Joshi SB, Smith DE, Middaugh CR, Prusik T, Volkin DB. Vaccine instability in the cold chain: Mechanisms, analysis and formulation strategies. Biologicals. 2014 Sep;42(5):237-59.
  • Alsenaidy MA, Okbazghi SZ, Kim JH, Joshi SB, Middaugh CR, Tolbert TJ, Volkin DB. Physical Stability Comparisons of IgG1-Fc Variants: Effects of N-Glycosylation Site Occupancy and Asp/Gln Residues at Site Asn 297. 2014 Jun;103(6):1613-27.
  • Alsenaidy MA, Jain NK, Kim JH, Middaugh CR, Volkin DB. Protein comparability assessments and potential applicability of high throughput biophysical methods and data visualization tools to compare physical stability profiles. Front Pharmacol. 2014 Mar 12;5:39.
  • Telikepalli SN, Kumru OS, Kalonia C, Esfandiary R, Joshi SB, Middaugh CR, Volkin DB. Structural Characterization of IgG1 mAb Aggregates and Particles Generated Under Various Stress Conditions. J Pharm Sci. 2014 Mar;103(3):796-809.
  • Werk T, Volkin DB, Mahler H-C. Effect of solution properties on the counting and sizing of subvisible particle standards as measured by light obscuration and digital imaging methods. European Journal of Pharmaceutical Sciences, 2014; 53:95-108.
  • Chaudhuri R, Cheng Y, Middaugh CR, Volkin DB. High-throughput biophysical analysis of protein therapeutics to examine interrelationships between aggregate formation and conformational stability. AAPS, 2014; 16(1):48-64.
  • Hickey JM, Holtz KM, Manikwar P, Joshi SB, McPherson CE, Buckland B, Srivastava IK, Middaugh CR, Volkin DB. Mechanism of a Decrease in Potency for the Recombinant Influenza A Virus Hemagglutinin H3 Antigen During Storage. J Pharm Sci. 2014 Mar;103(3):821-7.
  • Maddux NR, Iyer V, Cheng W, Youssef AM, Joshi SB, Volkin DB, Ralston JP, Winter G, Middaugh CR. High Throughput Prediction of the Long-Term Stability of Pharmaceutical Macromolecules from Short-Term Multi-Instrument Spectroscopic Data. J Pharm Sci. 2014 Mar;103(3):828-39.
  • Liyanage MR, Bakshi K, Volkin DB, Middaugh CR. Ultraviolet absorption spectroscopy of peptides. Methods Mol Biol. 2014;1088:225-36.
  • Liyanage MR, Bakshi K, Volkin DB, Middaugh CR. Fluorescence spectroscopy of peptides. Methods Mol Biol. 2014;1088:237-46.
  • Bakshi K, Liyanage MR, Volkin DB, Middaugh CR. Circular dichroism of peptides. Methods Mol Biol. 2014;1088:247-53.
  • Bakshi K, Liyanage MR, Volkin DB, Middaugh CR. Fourier transform infrared spectroscopy of peptides. Methods Mol Biol. 2014;1088:255-69.

2013

  • Khasa H, Kramer R, Maddux N, Hamborg M, Joshi SB, Volkin DB, Middaugh CR. Studies of the Aggregation of RNase Sa. J Pharm Sci. 2014 Feb;103(2):395-9.
  • Qi W, Zeng Y, Orgel S, Francon A, Kim JH, Randolph TW, Carpenter JF, Middaugh CR. Preformulation Study of Highly Purified Inactivated Polio Vaccine, Serotype 3. J Pharm Sci. 2014 Jan;103(1):140-51.
  • Dickenson NE, Arizmendi O, Patil MK, Toth RT, Middaugh CR, Picking WD, Picking WL. The N-terminus of IpaB provides a potential anchor to the Shigella type III secretion system tip complex protein IpaD. Biochemistry. 2013 Dec 10;52(49):8790-9.
  • Kramer RM, Zeng Y, Sahni N, Kueltzo LA, Schwartz RM, Srivastava IK, Crane L, Joshi SB, Volkin DB, Middaugh CR. Development of a Stable Virus-Like Particle Vaccine Formulation against Chikungunya Virus and Investigation of the Effects of Polyanions. J Pharm Sci. 2013 Oct 15; 102:4305-4314.
  • Cheng W, Joshi SB, Jain NK, He F, Kerwin BA, Volkin DB, Middaugh CR. Linking the Solution Viscosity of an IgG2 Monoclonal Antibody to Its Structure as a Function of pH and Temperature. J Pharm Sci. 2013 Oct 18; 102:4291-3204.
  • Kalonia C, Kumru OS, Kim JH, Middaugh CR, Volkin DB. Radar Chart Array Analysis to Visualize Effects of Formulation Variables on IgG1 Particle Formation as Measured by Multiple Analytical Techniques. J Pharm Sci. 2013 Dec;102(12):4256-67.
  • Alsenaidy MA, Kim JH, Majumdar R, Weis DD, Joshi SB, Tolbert TJ, Middaugh CR, Volkin DB. High-Throughput Biophysical Analysis and Data Visualization of Conformational Stability of an IgG1 Monoclonal Antibody After Deglycosylation. J Pharm Sci. 2013 Nov;102(11):3942-3956.
  • Iyer V, Hu L, Schanté CE, Vance D, Chadwick C, Jain N, Brey RN, Joshi SB, Volkin DB, Andra KK, Bann JG, Mantis NJ, Middaugh CR. Biophysical characterization and immunization studies of dominant negative inhibitor (DNI), a candidate anthrax toxin subunit vaccine. Hum Vaccin Immunother. 2013 Aug 7;9(11).
  • Thakkar SV, Sahni N, Joshi SB, Kerwin BA, He F, Volkin DB, Middaugh CR. Understanding the relevance of local conformational stability and dynamics to the aggregation propensity of an IgG1 and IgG2 monoclonal antibodies. Protein Sci. 2013 Oct;22(10):1295-305.
  • Cheng W, Curti E, Rezende WC, Kwityn C, Zhan B, Gillespie P, Plieskatt J, Joshi SB, Volkin DB, Hotez PJ, Middaugh CR, Elena Bottazzi M. Biophysical and formulation studies of the Schistosoma mansoni TSP-2 extracellular domain recombinant protein, a lead vaccine candidate antigen for intestinal schistosomiasis. Hum Vaccin Immunother. 2013 Jul 23;9(11).
  • Hamborg M, Kramer R, Schanté CE, Agger EM, Christensen D, Jorgensen L, Foged C, Middaugh CR. The Physical Stability of the Recombinant Tuberculosis Fusion Antigens H1 and H56. J Pharm Sci. 2013 Oct;102(10):3567-78.
  • Wang T, Kumru OS, Yi L, Wang YJ, Zhang J, Kim JH, Joshi SB, Middaugh CR, Volkin DB. Effect of ionic strength and pH on the physical and chemical stability of a monoclonal antibody antigen-binding fragment. 2013 Aug;102(8):2520-37.
  • Federici M, Lubiniecki A, Manikwar P, Volkin DB. Analytical lessons learned from selected therapeutic protein drug comparability studies. Biologicals. 2013 May; 41(3):131-47.
  • Manikwar P, Majumdar R, Hickey JM, Thakkar SV, Samra HS, Sathish HA, Bishop SM, Middaugh CR, Weis DD, Volkin DB. Correlating excipient effects on conformational and storage stability of an IgG1 monoclonal antibody with local dynamics as measured by hydrogen/deuterium-exchange mass spectrometry. J Pharm Sci. 2013 Apr 25; 102(7):2136-51.
  • Martinez-Becerra FJ, Scobey M, Harrison K, Choudhari SP, Quick AM, Joshi SB, Middaugh CR, Picking WL. Parenteral immunization with IpaB/IpaD protects mice against lethal pulmonary infection by Shigella. Vaccine. 2013 Apr 16; 31(24)2667-72.
  • Majumdar R, Manikwar P, Hickey JM, Samra HS, Sathish HA, Bishop SM, Middaugh CR, Volkin DB, Weis DD. Effects of Salts from the Hofmeister Series on Conformational Stability, Aggregation Propensity, and Local Flexibility of an IgG1 Monoclonal Antibody. Biochemistry. 2013 Apr 17; 52(19):3376-89.
  • Wang, T., Joshi, S.B., Kumru, O.S., Telikepalli, S., Middaugh, C. R., & Volkin, D. B. (2013). Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size. In Biophysics for Therapeutic Protein Development (pp. 205-243). Springer New York.
  • Middaugh, C. R., Volkin, D. B., & Joshi, S. B. (2013). High Throughput Screening for Stabilizers of Vaccine Antigens. In Novel Immune Potentiators and Delivery Technologies for Next Generation Vaccines (pp. 119-143). Springer US.
  • Choudhari SP, Kramer R, Barta ML, Greenwood JC 2nd, Geisbrecht BV, Joshi SB, Picking WD, Middaugh CR, Picking WL. Studies of the conformational stability of invasion plasmid antigen B from Shigella. Protein Sci. 2013 May;22(5):666-70.
  • Dickenson NE, Choudhari SP, Adam PR, Kramer RM, Joshi SB, Middaugh CR, Picking WL, Picking WD. Oligomeric states of the Shigella translocator protein IpaB provide structural insights into formation of the type III secretion translocon.  Protein Sci. 2013 May;22(5):614-27.
  • Thomas JC, O'Hara JM, Hu L, Gao FP, Joshi SB, Volkin DB, Brey RN, Fang J, Karanicolas J, Mantis NJ, Middaugh CR. Effect of single-point mutations on the stability and immunogenicity of a recombinant ricin A chain subunit vaccine antigen. Hum Vaccin Immunother. 2013 Apr 1;9(4):740-748.
  • Liu J, Blasie CA, Shi S, Joshi SB, Middaugh CR, Volkin DB. Characterization and stabilization of recombinant human protein pentraxin (rhPTX-2). J Pharm Sci.  2013 Mar;102(3):827-41
  • Hu L, Joshi SB, Liyanage MR, Pansalawatta M, Alderson MR, Tate A, Robertson G, Maisonneuve J, Volkin DB, Middaugh CR. Physical characterization and formulation development of a recombinant pneumolysoid protein-based pneumococcal vaccine. J Pharm Sci. 2013 Feb;102(2):387-400.
  • Iyer V, Maddux N, Hu L, Cheng W, Youssef AK, Winter G, Joshi SB, Volkin DB, Middaugh CR. Comparative signature diagrams to evaluate biophysical data for differences in protein structure across various formulations. J Pharm Sci. 2013 Jan;102(1):43-51.
  • Xiao Y, Zeng Y, Alexander E, Mehta S, Joshi SB, Buchman GW, Volkin DB, Middaugh CR, Isaacs SN. Adsorption of recombinant poxvirus L1-protein to aluminum hydroxide/CpG vaccine adjuvants enhances immune responses and protection of mice  from vaccinia virus challenge. Vaccine. 2013 Jan 2;31(2):319-26.

2012

  • Thakkar SV, Kim JH, Samra HS, Sathish HA, Bishop SM, Joshi SB, Volkin DB, Middaugh CR. Local dynamics and their alteration by excipients modulate the global conformational stability of an lgG1 monoclonal antibody. J Pharm Sci. 2012 Dec;101(12):4444-57
  • Majumdar R, Manikwar P, Hickey JM, Arora J, Middaugh CR, Volkin DB, Weis DD. Minimizing Carry-Over in an Online Pepsin Digestion System used for the H/D Exchange Mass Spectrometric Analysis of an IgG1 Monoclonal Antibody. J Am Soc Mass Spectrom. 2012 Dec;23(12):2140-8.
  • Hu L, Joshi SB, Andra KK, Thakkar SV, Volkin DB, Bann JG, Middaugh CR. Comparison of the structural stability and dynamic properties of recombinant anthrax protective antigen and its 2-fluorohistidine-labeled analogue. J Pharm Sci. 2012 Nov;101(11):4118-28.
  • Kim JH, Iyer V, Joshi SB, Volkin DB, Middaugh CR. Improved data visualization techniques for analyzing macromolecule structural changes. Protein Sci. 2012 Oct;21(10):1540-53.
  • Kumru OS, Liu J, Ji JA, Cheng W, Wang YJ, Wang T, Joshi SB, Middaugh CR,Volkin DB. Compatibility, physical stability, and characterization of an IgG4monoclonal antibody after dilution into different intravenous administration bags. J Pharm Sci. 2012 Oct;101(10):3636-50.
  • Thakkar SV, Joshi SB, Jones ME, Sathish HA, Bishop SM, Volkin DB, Middaugh CR. Excipients differentially influence the conformational stability andpretransition dynamics of two IgG1 monoclonal antibodies. J Pharm Sci. 2012 Sep;101(9):3062-77.
  • Thakkar SV, Allegre KM, Joshi SB, Volkin DB, Middaugh CR. An application of ultraviolet spectroscopy to study interactions in proteins solutions at high concentrations. J Pharm Sci. 2012 Sep;101(9):3051-61.
  • Iyer V, Hu L, Liyanage MR, Esfandiary R, Reinisch C, Meinke A, Maisonneuve J, Volkin DB, Joshi SB, Middaugh CR. Preformulation characterization of an aluminum salt-adjuvanted trivalent recombinant protein-based vaccine candidate againststreptococcus pneumoniae. J Pharm Sci. 2012 Sep;101(9):3078-90.
  • Iyer V, Liyanage MR, Shoji Y, Chichester JA, Jones RM, Yusibov V, Joshi SB, Middaugh CR. Formulation development of a plant-derived h1n1 influenza vaccine containing purified recombinant hemagglutinin antigen. Hum Vaccin Immunother. 2012 Apr;8(4):453-64.
  • Plieskatt JL, Rezende WC, Olsen CM, Trefethen JM, Joshi SB, Middaugh CR, Hotez PJ, Bottazzi ME. Advances in vaccines against neglected tropical diseases: enhancing physical stability of a recombinant hookworm vaccine through biophysical and formulation studies. Hum Vaccin Immunother. 2012 Jun;8(6):765-76.
  • Maddux NR, Rosen IT, Hu L, Olsen CM, Volkin DB, Middaugh CR. An improvedmethodology for multidimensional high-throughput preformulation characterization of protein conformational stability. J Pharm Sci. 2012 Jun;101(6):2017-24.
  • Shi S, Liu J, Joshi SB, Krasnoperov V, Gill P, Middaugh CR, Volkin DB. Biophysical characterization and stabilization of the recombinant albumin fusion protein sEphB4-HSA. J Pharm Sci. 2012 Jun;101(6):1969-84.
  • Cheng W, Joshi SB, He F, Brems DN, He B, Kerwin BA, Volkin DB, Middaugh CR. Comparison of high-throughput biophysical methods to identify stabilizing excipients for a model IgG2 monoclonal antibody: conformational stability and kinetic aggregation measurements. J Pharm Sci. 2012 May;101(5):1701-20.
  • Bhambhani A, Kissmann JM, Joshi SB, Volkin DB, Kashi RS, Middaugh CR. Formulation design and high-throughput excipient selection based on structural integrity and conformational stability of dilute and highly concentrated IgG1 monoclonal antibody solutions. J Pharm Sci. 2012 Mar;101(3):1120-35.

2011

  • Hu L, Olsen C, Maddux N, Joshi SB, Volkin DB, Middaugh CR. Investigation of protein conformational stability employing a multimodal spectrometer. Anal Chem. 2011 Dec 15; 83(24):9399-405.
  • Hu L, Trefethen JM, Zeng Y, Yee L, Ohtake S, Lechuga-Ballesteros D, Warfield KL, Aman MJ, Shulenin S, Unfer R, Enterlein SG, Truong-Le V, Volkin DB, Joshi SB, Middaugh CR. Biophysical characterization and conformational stability of Ebola and Marburg virus-like particles. J Pharm Sci. 2011 Dec; 100(12):5156-73.
  • Alsenaidy MA, Wang T, Kim JH, Joshi SB, Lee J, Blaber M, Volkin DB, Middaugh CR. An empirical phase diagram approach to investigate conformational stability of "second-generation" functional mutants of acidic fibroblast growth factor (FGF-1). Protein Sci. 2011 Nov 23; 21(3):418-32.
  • Kamerzell TJ, Esfandiary R, Joshi SB, Middaugh CR, Volkin DB. Protein-excipient interactions: mechanisms and biophysical characterization applied to protein formulation development. Adv Drug Deliv Rev. 2011 Oct; 63(13):1118-59.
  • Maddux NR, Joshi SB, Volkin DB, Ralston JP, Middaugh CR. Multidimensional methods for the formulation of biopharmaceuticals and vaccines. J Pharm Sci. 2011 Jun 6; 100(10):4171-97.
  • Zeng, Y., Ramsey, J.D., King, R., Leviten, M., McGuire, R., Volkin, D.B., Joshi, S.B., Middaugh, C.R. Identifying stabilizers of plasmid DNA for pharmaceutical use. J. Pharm. Sci. 2011 Mar; 100(3):904-14.
  • Kissmann, J., Joshi, S.B., Haynes, J.R., Dokken, L., Richardson, C., Middaugh, C.R. H1N1 influenza virus-like particles: Physical degradation pathways and identification of stabilizers. J. Pharm. Sci. 2011 Feb; 100(2):634-45.

2010

  • Markham AP, Barrett BS, Esfandiary R, Picking WL, Picking WD, Joshi SB, Middaugh CR. Formulation and immunogenicity of a potential multivalent type III secretion system-based protein vaccine. J Pharm Sci. 2010 Nov;99(11):4497-509.
  • Barrett BS, Markham AP, Esfandiary R, Picking WL, Picking WD, Joshi SB, Middaugh CR. Formulation and immunogenicity studies of type III secretion system needle antigens as vaccine candidates. J Pharm Sci. 2010 Nov;99(11):4488-96.
  • Esfandiary, R., Yee, L., Ohtake, S., Martin, R.A., Truong-Le, V.L., Lechuga-Ballesteros, D., Moore, D.S., Joshi, S.B., Middaugh, C.R. Biophysical characterization of rotavirus serotypes G1, G3 and G4. Hum Vaccin. 6(5):390-398.
  • He, F., Joshi, S.B., Moore, D.S., Shinogle, H.E., Ohtake, S., Lechuga-Ballesteros, D., Martin, R.A., Truong-Le, V.L., Middaugh, C.R. Using spectroscopic and microscopic methods to probe the structural stability of human adenovirus type 4. Hum Vaccin. 6(2):202-211.
  • Hem, S.L., HogenEsch, H., Middaugh, C.R., Volkin, D.B. Preformulation studies-The next advance in aluminum adjuvant-containing vaccines. Vaccine. 28(31):4868-4870.
  • Volkin, D.B., Middaugh, C.R. Vaccines as physically and chemically well-defined pharmaceutical dosage forms. Expert Review of Vaccines. 9(7):689-691
  • Samra, H.S., He, F., Bhambhani, A., Pipkin, J.D., Zimmerer, R., Joshi, S.B., Middaugh, C.R. The effects of substituted cyclodextrins on the colloidal and conformational stability of selected proteins. J. Pharm. Sci. 99(6):2800-2818.

2001-2009

  • (2009) Esfandiary, R., Hunjan, J.S., Lushington, G.H., Joshi, S.B., Middaugh, C. R. Temperature dependent 2nd derivative absorbance spectroscopy of aromatic amino acids as a probe of protein dynamics. Protein Science. 18(12), 2603-2614
  • (2009) Markham, A.P., Jaafar, Z.A., Kemege, K.E., Middaugh, C. R., Hefty, P.S. Biophysical Characterization of Chlamydia trachomatis CT584 Supports its Potential Role as a Type III Secretion Needle Tip Protein. Biochemistry. 48(43), 10353-10361
  • (2009) Cai, S., He, F., Samra, H.S., de la Maza, L.M., Bottazzi, M.E., Joshi, S.B., Middaugh, C. R. Biophysical and stabilization studies of the Chlamydia trachomatis mouse pneumonitis major outer membrane protein. Molecular Pharmaceutics. 6(5), 1553-1561
  • (2009) Esfandiary, R., Kickhoefer, V.A., Rome, L.H., Joshi, S.B.and Middaugh, C.R. Structural stability of vault particles. J. Pharm. Sci. 98, 1376-1386
  • (2009) Ramsey, J.D., Gill, M.L., Kamerzell, T.J, Price, E.S., Joshi, S.B., Bishop, S.M., Oliver, C.N. and Middaugh, C.R. Using empirical phase diagrams to understand the role of intramolecular dynamics in immunoglobuilin G stability. J. Pharm Sci., 98(7):2432-47.
  • (2009) Zeng, Y., Fan, H., Chiueh, G., Pham, B., Martin, R., Lechuga-Ballesteros, D., Truong, V., Joshi, S.B.and Middaugh, C. R. Towards development of stable formulations of a live attenuated bacterial vaccine: A preformulation study facilitated by a biophysical approach. Human Vaccine, 5(5):322-31.
  • (2009) Trivedi, M., Davis, RA., Shabaik, Y., Roy, A., Verkhivker, G., Laurence, JS., Middaugh, CR. And Siahaan, TJ. The role of covalent dimerization on the physical and chemical stability of the EC1 domain of human E-cadherin. J. Pharm.Sci, 98(10):3562-74.
  • (2009) He, F., Joshi S.B., Bosman, F., Verhaeghe, M., and Middaugh, C.R. Structural Stability of Hepatitis C Virus Envelope Glycoprotein E1: Effect of pH and Dissociative Detergents. J. Pharm Sci., 98(9):3340-57.
  • (2008) Ausar, S.A., Joshi, S.B. and Middaugh C.R. Spectroscopic methods for the Physical Characterization and Formulation of Nonviral Gene Delivery Systems. Methods Mol. Biol. 434, 55-80
  • (2008) Markham, A.P, Birket, S.E., Picking, W.D., Picking, W.L. and Middaugh, C.R. pH sensitivity of Type III secretion tip proteins. Proteins: Struct., Funct., Proteomics, 71, 1830-1842
  • (2008) Barrett, B.S., Picking, W.L., Picking, W.D., and Middaugh, C.R. The response of the TTSS needle proteins MxiHdelta5, BsaLdelta5 and PrgIdelta5 to temperature and pH. Proteins: Struct., Funct., Proteomics., 73, 632-643
  • (2008) Nonoyama, A., Lawrence, J. Garriques, L., Hong, Q., Thao, L and Middaugh, C.R. A biophysical characterization of the peptide drug Pramlintide (AC137) using empirical phase diagrams. J. Pharm. Sci, 97, 2552-2567
  • (2008) Salnikova, M., Joshi, S.B., Rytting, J.H., Warny, M., and Middaugh, C.R. Physical characterization of clostridium difficile toxins and toxoids-effect of formaldehyde crosslinking on thermal stability. J. Phar. Sci., 97, 3735-3752
  • (2008) Kamerzell, T.L., Ramsey, J and Middaugh, C.R. Immunoglobulin Dynamics, Conformational Fluctuations and Nonlinear Elasticity and their Effects on Stability. J. Phy. Chem., 112, 3240-3250
  • (2008) Salnikova, M.S., Joshi, S.B., Rytting, J.H., Warny, M and Middaugh, C.R. Preformulation Studies of Clostridium difficile Toxoids A and B. J. Pharm Sci., 97, 4194-4207
  • (2008) Kissmann J., Ausar, S.F., Foubert, T. A., Brock, J., Switzer, M.H., Detzi, E.J., Vedvick, T.S., and l Middaugh, C. R. Physical Stabilization of Norwalk Virus-Like Particles. J.Pharm.Sci., 97, 4208-4218
  • (2008) Fang, J., Dong, Y., Salamat-Miller, N. And Middaugh, C.R. DB-PABP: a database of polyanion-binding proteins. Nucleic Acids Research. 36, 0303-0306
  • (2008) Peek, L.J., Middaugh, C.R. and Berkland, C. Nanotechnology in Vaccine Delivery. Adv. Drug Deliv. Rev., 60, 915-928
  • (2008) Kamerzell, T.J. and Middaugh, C.R. The Complex Inter-Relationships between Protein Flexibility and Stability. J. Pharm.Sci., 97, 3494-3517
  • (2008) Salnikova, M., Rytting, J.H., Warny, M., and Middaugh, C.R. Stability of Human Growth Hormone in Lyophilized Formulations. Int. J. Pharmacy., 358,108-113.
  • (2008) Li, Q-S., Cai, S., Borchardt, R.T., Fang, J., Kuzera, K., Middaugh, C.R. and Schowen, R.L. Comparative Kinetics of Cofactor Association and Dissociation for the Human and Trypanosomal S-adenosylhomecysteine Hydrolases. 2. The Role of helix 18 stability. Biochemistry, 47, 4983-4991.
  • (2008) Kissmann, J., Ausar, S.F., Rudolph, A., Braun, C., Cape, S.P., Sievers, R.F., Federspiel, M. J., Joshi, S.B. and Middaugh, C.R. Stabilization of Measles Virus for Vaccine Formulation, Human Vaccine, 4(5), 350-359
  • (2008) Brooks, A.E., Stricker, S.M., Joshi, S.B., Kamerzell, T.J., Middaugh, C.R. and Lewis, R.V. Properties of synthetic spider silk fibers based on Argiope aurantia MaSp2. Biomacromolecules. 9, 1506-1510.
  • (2007) Fang, J., Dong, Y., Salamat-Miller, N. And Middaugh, C.R. DB-PABP: a database of polyanion-binding proteins. Nucleic Acids Research. 36:D303-D306. 
  • (2007) Kissmann J., Ausar, S.F., Foubert, T. A., Brock, J., Switzer, M.H., Detzi, E.J., Vedvick, T.S., and l Middaugh, C. R. Physical Stabilization of Norwalk Virus-Like Particles. J.Pharm.Sci. 97(10):4208-18.
  • (2007) Salnikova, M.S., Joshi, S.B., Rytting, J.H., Warny, M and Middaugh, C.R. Preformulation Studies of Clostridium difficile Toxoids A and B. J. Pharm Sci. 97(10):4194-207.
  • (2007) Kamerzell, T.L., Ramsey, J and Middaugh, C.R. A statistical mechanical view of immunoglobulin dynamics. J. Phy. Chem.
  • (2007) Salnikova, M., Joshi, S.B., Rytting, J.H., Warny, M., and Middaugh, C.R. Physical characterization of clostridium difficile toxins and toxoids-effect of formaldehyde crosslinking on thermal stability. J. Phar. Sci., in press.
  • (2007) Nonoyama, A., Lawrence, J. Garriques, L., Hong, Q., Thao, L and Middaugh, C.R. A biophysical characterization of the peptide drug Pramlintide (AC137) using empirical phase diagrams. J. Pharm. Sci, in press.
  • (2007) Birket, S.E., Harrington, A.T., Espina, M., Smith, N.D., Terry, C.M., Darboe, N., Markham, A.P., Middaugh, C.R., Picking, W.L. and Picking, W.D. Preparation and characterization of traslocator/chaperone complexes and their proteins from shigella flexineri. Biochemistry, 46, 8128-8137.
  • (2007) Kamerzell, T., and Middaugh, C.R. Two dimensional correlation spectroscopy reveals coupled immunoglobin regions of differential flexibility and Influence stability. Biochemistry, 46, 9762-9773.
  • (2007) Barrett, B.S., Picking, W.L., Picking, W.D., and Middaugh, C.R. The response of the TTSS needle proteins MxiHdelta5, BsaLdelta5 and PrgIdelta5 to temperature and pH. Submitted to Proteins: Struct., Funct., Proteomics.
  • (2007) Markham, A.P, Birket, S.E., Picking, W.D., Picking, W.L. and Middaugh, C.R. pH sensitivity of Type III secretion tip proteins. Proteins: Struct., Funct., Proteomics, in press.
  • (2007) Zheng, K., Lawrence, J.S.., Kuczera, K., Middaugh, C.R., and Siahaan, T.J. Characterization of multiple stable conformers of the fifth extracellular domain of E-cadherin. Submitted to J. Biol. Chem.
  • (2007) Middaugh, C.R. and Ramsey, J.D. Analysis of cationic lipid/plasmid DNA complexes. Anal Chem, 79(19), 7240-7248.
  • (2007) Joshi, S.B., Kamerzell, T., McNown, C.W. and Middaugh, C.R. Interaction of polyanions with bovine, porcine and human growth hormones: Effect on physical stability of these proteins. J. Pharm Sci, in press.
  • (2007) Kamerzell, T., Joshi, S.B., McClean, D., Peplinskie, L., Toney, K, Papac, D., Li, M., and Middaugh, C.R.. Parathyroid Hormone is a Heparin/Polyanion Binding Protein:Binding Energetics and Structure Modification. Protein Science. 16,1193-1203.
  • (2007) Brandau, D.T., Joshi, S.B., Smalter, A.M., Kim, S., Steadman, B and Middaugh, C.R. Stability of the Clostridium botulinum type A neurotoxin Complex: An Empirical Phase Diagram Based Approach. Mol. Pharm, 2007, 10.1021/mp0601244.
  • (2007) Ausar, S.A., Joshi, S.B. and Middaugh C.R. Methods for the Physical Characterization and Formulation of Nonviral Gene Delivery Systems. Methods in Molecular Biology: Gene Therapy Protocols, 3rd Edition (LeDoux J., Ed.), Humana Press, Totowa, NJ.
  • (2007) Ausar, S.F., Espina, M., Brock, J., Thyagrajapuram, N., Repetto, R. Khandke, L. and Middaugh, C.R. High through put screening of stabilizers for respiratory syncytial virus:identification of stabilizers and their effects on the formational thermostability of viral particles. Human vaccines. In press.
  • (2007) Li, Q.S., Cai, S., Borchardt, r.T., Fang, J., Kuczera, J., Middaugh, C.R. and Schowen, R.L. Comparative kinetics of cofactor association and dissociation for the human and trypanosomal S-adenosylhomo cysteine hydrolases. 1. basic features of the association and dissociation processes. Biochemistry, 46(19), 5798-5809.
  • (2007) Thyagrajapuram, N., Olsen, D. and Middaugh C.R. Stabilization of proteins by recombinant human gelatins. J. Pharm. Sci., 10.1002/jps.20980.
  • (2007) Thyagrajapuram, N., Olsen, D. and Middaugh C.R. The structure stability and complex behavior of recombinant human gelatins. J. Pharm. Sci., 2007, 10.1002/jps.21022.
  • (2007) Espina, M., Ausar, S.F., Middaugh, C.R., Baxter, M.A., Picking, W.D., and Picking, W.L. Conformational stability and differential structural analysis of LcrV, PcrV, BipD and SipD from Type III secretions systems. Protein Sci., Apr 2007, 16:704-714.
  • (2007) Salamat-Miller N., Fang J., Seidel C., Smalter A., Assenov Y., Albrecht M., and Middaugh C.R. A network-based analysis of polyanions binding proteins utilizing human protein arrays. J. Biol.Chem., in press.
  • (2007) Tian F. Middaugh C.R., Offerdahl T., Munson E., Sane S., Rytting J.H. Spectroscopic evaluation of the stabilization of humanized monoclonal antibodies in amino acid formulations. Int. J. Pharm., 2007 Apr 20, 335(1-2):20-31.
  • (2007) Fan H., Li H., Zhang M., Middaugh C.R. Effects of solutes on empirical phase diagrams of human fibroblast growth factor 1. J. Pharm. Sci., 2007, 10.1002/jps.20796.
  • (2007) Peek L.J., Martin T., Elk Nation C., Pegram S., Middaugh C.R. Effects of stabilizers on the destabilization of proteins upon adsorption to aluminum salt adjuvants. J Pharm. Sci., 2007 Mar, 96(3):547-57.
  • (2007) Harn N., Allan C., Oliver, C. Middaugh C.R. Highly Concentrated Monoclonal Antibodies: Direct Analysis of Structure and Stability. J. Pharm. Sci., 2007 Mar, 96(3):532-46.
  • (2007) Peek L.J., Brey R.N., Middaugh C.R. A rapid, three-step process for the preformulation of a recombinant ricin toxin A-chain vaccine. J. Pharm. Sci., 2007 Jan, 96(1):44-60.
  • (2007) Priddy, T.S., Middaugh, C.R. and Carlson, G.M. Electrostatic changes in phosphorylase kinase induced by its obligatory allosteric activator Ca2+. Protein Sci.,16, 517-527.
  • (2007) Derrick T., Grillo A.O., Vitharana S.H., Jones L.S., Rexroad J., Shah A., Perkins M., Spitznagel T. M., Middaugh C.R. Effect of polyanions on the structure and stability of Repifermin? (keratinocyte growth factor-2). J. Pharm. Sci, 5, 2263-2278
  • (2006) Kamerzell, T.J., Unruh, J.R., Johnson, C.K., and Middaugh, C.R. Conformational flexibility, hydration and state parameter fluctuations of fibroblast growth factor-10:effects of ligand binding. Biochemistry, 45, 15288-15300
  • (2006) Salamat-Miller N. Fang J. Seidel C. Smalter A. Assenov Y. Albrecht M. Middaugh C.R. A network-based analysis of polyanions binding proteins utilizing yeast protein arrays. Mol. Cell. Proteomics, 2006 Dec, 5(12):2263-78.
  • (2006) D’Souza A.M.J., Hart D.S., Middaugh C.R., Gehrke S.H. Characterization of he changes in secondary structure and architecture of elastin-mimetic triblock polypeptides during thermal gelation. Macromolecules, in press.
  • (2006) Lucas L.H., Ersoy B. A., Kueltzo L.A., Joshi S.B., Brandau, D.T., Thyagarajapurum N., Peek L.J., Middaugh C.R. Probing protein structure and dynamics by second derivative ultraviolet absorption analysis of cation-? interactions. Protein Sci, 2006 Oct, 15(10):2228-43.
  • (2006) Guo J., Harn N., Robbins A., Dougherty R., Middaugh C.R. Stability of helical-rich proteins at high concentration. Biochemistry, 45(28), 8686-96.
  • (2006) Peek L.J., Brandau D.T., Jones L.S., Joshi S.B.,Middaugh C.R. A systematic approach to stabilizing EBA-175 RII-NG for use as a malaria vaccine. Vaccine, 24(31-32), 5839-5851.
  • (2006) Espina M, Olive AJ, Kenjale R, Moore DS, Ausar SF, Kaminski RW, Oaks EV, Middaugh CR, Picking WD, Picking WL. IpaD localizes to the tip of the type III secretion system needle of Shigella flexneri). Infection and Immunity, 74(8), 4391-4400.
  • (2006) Espina M, Ausar SF, Middaugh CR, Picking WD, Picking WL. Spectroscopic and calorimetric analyses of IpaD from Shigella flexneri reveal the presence of two structural domains. Biochemistry 45(30), 9219-9227
  • (2006) Ausar S.F., Foubert T.R., Hudson M.H., Vedvick T.S., Middaugh C.R. Conformational stability and disassembly of Norwalk virus like particles: Effect of pH and temperature. J. Biol. Chem. 281(28), 19478-19488.
  • (2006) Ruponen M., Braun C.S., and Middaugh C.R. Biophysical characterization of polymeric and liposomal gene delivery systems using empirical phase diagrams. J Pharm Sci., 95(10), 2101-2114.
  • (2006) Rexroad, J., Martin, T.T., McNeilly, D., Godwin, S. and Middaugh, C.R. Thermal stability of Adenovirus 2 as a function of pH. J. Pharm. Sci., 95(7), 1469-1479.
  • (2006) Darboe, N., Kenjale, R., Picking, W.L., Picking, W.D., and Middaugh, C.R. Chemical denaturation of MxiH from Shigella and PrgI from Salmonella. Prot. Sci., 15, 543-552.
  • (2006) Fan, H., Kashi, R.S. and Middaugh, C.R. Conformational lability of two molecular chaperones HSc 70 and GP 96: Effects of pH and temperature. Arch Biochem. Biophys., 447, 34-45.
  • (2006) Harrington, A.T., Darboe, N., Picking, W.L., Middaugh, C.R., Birket, S., and Picking, W.D. Characterization of the interaction of a single tryptophan containing mutants of IpaC from Shigella flexneri with phospholipids membranes. Biochemistry, 45(2),626-636.
  • (2006) Purohit, V.S., Middaugh, C. R. and Balasubramanian, S.V. Influence of aggregation on the immunogenicity of recombinant human factor VIII in hemophilia mice. J. Pharm. Sci. 95, 358-371.
  • (2006) Jiang, G., Joshi, S. B., Peek, L. J., Brandau, D. T., Huang, C. R., Ferriter, M. S., Woodley, W. D., Ford, B. M., Mar, K. D., Mikszta, J. A., Hwang, C. R., Ulrich, R., Harvey, N. G., Middaugh, C. R. and Sullivan, V. J. Anthrax vaccine powder formulations for nasal mucosal delivery. J. Pharm. Sci. 95, 80-96.
  • (2005) Ausar, S.F., Rexroad, J., Frolov, V.G., Look, J.L., Konar, N. and Middaugh, C.R. Analysis of the thermal stability of respiratory syncytial virus. Mol. Pharm. 2, 491-499
  • (2005) Tumanova, I., Boyer, J., Ausar, S.F., Burzynski, J., Rosencrance, D., White, J., Schiedel, J., Parkinson, R., Maguire, H., Middaugh, C.R., Weiner, D., and Green, A. P. Analytical and biological characterization of supercoiled plasmids purified by various chromatographic techniques. DNA and Cell Biol 24,819-831.
  • (2005) Harn, N.R., Jeng, Y.N., Kostelec, J. C., and Middaugh, C.R. Spectroscopic analysis of highly concentrated suspensions of bovine somatotropin in sesame oil. J. Pharm. Sci., 94,2487-2497.
  • (2005) Fan, H., Ralston, J., DiBase, M., Faulkner, E., and Middaugh, C.R., The solution behavior of IFN-ß-1a: An empirical phase diagram approach. J Pharm. Sci., 94, 1893-1911.
  • (2005) Rexroad, J., Evans, R. K., and Middaugh, C. R. Effect of pH and ionic strength on the physical stability of adenovirus type 5. J. Pharm. Sci., 95,237-247.
  • (2005) Ramani, K., Purohit, V., Middaugh, C.R., and Balasubramauian, S.V. Aggregation kinetics of recombinant human FVIII (rFVIII). J. Pharm. Sci. 94, 2023-2029.
  • 2005) Ramani, K., Purohit, V.S., Miclea, R.D., Middaugh, C.R. and Balasubramanian, S.V., Lipid binding region (2303-2332) is involved in aggregation of recombinant human factor VIII(rFVIII), J. Pharm. Sci. 94, 1288-1299.
  • (2005) Krogmeier, S.L., Reddy, D.S., Vander Velde, D., Lushington, G.H., Siahaan, T.J., Middaugh, C.R., Borchardt, R.T., and Topps, E.M. “Deamidation of Model [(beta)]—Turn Cyclin Peptides in the Solid State.” J. Pharm. Sci., 94, 2616-2631.
  • (2005) Ramani, K., Purohit, V.S., Miclea, R.D., Middaugh, C.R. and Balasubramanian, S.V. “Lipid Binding Region (2303-2332) is involved in Aggregation of Recombinant Human FVIII (rFVIII).” J. Pharm Sci., 94, 1288-1299.
  • (2005) Kueltzo, L.A. and Middaugh, C.R. “Molten Globule-Lipid Interactions and Their Implications for Protein Transport and Aggregation” in Protein (Mis)Folding, Aggregation and Stability (Tsai, A. and Murphy, R.M., eds.), Kluwer Academic Press.
  • (2005) Braun, C.S., Fisher, M.T., Tomalia, D.T., Koe, G.S., Koe, J.G., and Middaugh, C.R. “A Stopped-Flow Kinetic Study of the Assembly of Nonviral Gene Delivery Complexes,” Biophys. J., 88, 4146-4158.
  • (2005) Kueltzo, L.A. and Middaugh, C.R. “Polycationic Peptides and Proteins in Drug Delivery” in Drug Delivery: Principles and Applications (Wang, B., Siahaan, T. and Soltero, R., eds.), John Wiley & Sons.
  • (2005) Jones, L.S., Kaufmann, A. and Middaugh, C.R. “Silicone Oil Induced Aggregation of Proteins,” J. Pharm. Sci., 94, 918-927.
  • (2005) Jones, L.S., Peek, L.J., Power, J., Markham, A., Yazzi, B. and Middaugh, C.R. “Effects of Absorption to Aluminum Salt Adjuvants on the Structure and Stability of Model Protein Antigens,” J. Biol. Chem., 280, 13406-13416.
  • (2005) Braun, C.S., Vetro, J.A., Tomalia, D.A., Koe, G.S., Koe, J.G. and Middaugh, C.R. “Structure/Function Relationships of Polyamidoamine/DNA dendrimers as Gene Delivery Vehicles,” J. Pharm. Sci., 94, 423-436.
  • (2004) Derrick, T.S., Kashi, R.S., Durrani, M., Jhingan, A. and Middaugh, C.R. “Effect of Metal Cations on the Conformation and Inactivation of Recombinant Human Factor VII (rhFVIII)”, J. Pharm. Sci., 93, 2549-57.
  • (2004) Kueltzo, L.A. and Middaugh, C.R. “Ultraviolet Absorption Spectroscopy” in Methods for Structural Analysis of Protein Pharamceuticals (Jiskoot, W. ed.) AAPS Publications.
  • (2004) Jones, L.S., Yazzi, B. and Middaugh, C.R. “Polyanions and the Proteome”, Mol. Cell Proteomics, 3, 746-769.
  • (2004) Stotz, C.E., Borchardt, R.T., Middaugh, C.R., Siahaan, T.J., Vander Velde, D. and Topp, E.M. “Secondary Structure of a Dynamic Type I’ Beta Hairpin Peptide,” J. Peptide Res., 63, 371-82.
  • (2004) Wiethoff, C.M., Koe, J.G., Koe, G.S. and Middaugh, C.R. Compositional Effects of Cationic Lipid/DNA Delivery Systems on Transgene Expression in Cell Culture. J. Pharm Sci., 93, 108-23.
  • (2003) Kueltzo, L.A. and Middaugh, C.R. “Nonclassical Transport of Proteins and Peptides: An Alternative to Classical Macromolecular Delivery Systems.” J. Pharm. Sci., 92, 1754-72.
  • (2003) Lobo, B.A., Vetro, J.A., Suich, D.M., Zuckerman, R.N. and Middaugh, C.R. “Structure/Function Analysis of Peptoid/Lipitoid: DNA Complexes.” J. Pharm. Sci., 92, 1905-18.
  • (2003) Tiyaboonchai, W., Woiszwillo, J., Sims, R.C. and Middaugh, C.R. Insulin Containing Polyethylenimine-Dextran Sulfate Nanoparticles. Int. J. Pharm., 255, 139-151.
  • (2003) Tiyaboonchai, W., Woiszwillo, J. and Middaugh, C.R. Formulation and Characterization of Polyethylenimine-Dextran Sulfate Nanoparticles. Eur. J. Pharm. Sci., 19, 191-202.
  • (2003) Lobo, B.A., Koe, G.S., Koe, J.G. and Middaugh, C.R.. Thermodynamic analysis of binding and protonation in DOTAP:DOPE (1:1): DNA complexes using isothermal titration calorimetry. Biophys. Chem., 104, 67-78.
  • (2003) Kueltzo, L.A., Osiecki, J., Barker, J., Picking, W.L., Ersoy, B., Picking, W.D. and Middaugh, C.R. Structure-Function Analysis of Invasion Plasmid Antigen C (IpaC) from Shigella flexneri. J. Biol. Chem., 278, 2792-8.
  • (2003) Kueltzo, L.A. and Middaugh, C.R. Structural Characterization of Bovine Granulocyte Colony Stimulating Factor: Effect of Termperature and pH. J. Pharm Sci., 92, 1793-1804.
  • (2003) Kueltzo, L.A., Ersoy, B., Darrington, T., Ralston, J.P. and Middaugh, C.R. Derivative Absorbance Spectroscopy and Protein Phase Diagrams as Tools for Comprehensive Protein Characterization: A bGCSF Case Study. J. Pharm. Sci., 92, 1805-30.
  • (2003) Choosakoonkriang, S., Koe, G.S., Smith, J.G., Middaugh, C.R. Biophysical Characterization of PEI/DNA Complexes. J. Pharm. Sci., 92, 1710-1722.
  • (2003) Braun, C.S., Jas, G.S., Choosakoonkriang, S., Koe, G.S., Smith, J.G., Middaugh, C.R. The Structure of DNA within Cationic Lipid/DNA Complexes. Biophys. J., 84, 1114-23.
  • (2002) Wiethoff, C.M. Koe, J.G., Koe, G.S. and Middaugh, C.R. The Structural Organization of Cationic Lipid/DNA Complexes. J. Biol. Chem., 277, 44980-44987.
  • (2003) Rexroad, J., Wiethoff, C.M., Green, A.P., Kierstead, T.D., Scott, M.O., Middaugh, C.R. Structural stability of adenovirus type 5. J. Pharm Sci., 92, 665-78.
  • (2003) Wiethoff, C.M., Koe, J.G., Koe, G.S. and Middaugh, C.R. A Fluorescence Study of the Structure and Accessibility of Plasmid DNA Condensed with Cationic Gene Delivery Vehicles. J. Pharm. Sci., 92, 1272-1285.
  • (2003) Choosakoonkriang, S., Wiethoff, C.M., Koe, G.S., Koe, J.G., Anchordoquy, T.J. and Middaugh, C.R. An Infrared Spectroscopic Study of the Effect of Hydration on Cationic Lipid/DNA Complexes. J. Pharm. Sci., 92, 115-30.
  • (2003) Wiethoff, C.M. and Middaugh, C.R. Barriers to Nonviral Gene Delivery. J. Pharm. Sci., 92, 203-17.
  • (2003) Brandau, D.T., Jones, L.S., Wiethoff, C.M., Rexroad, J., Middaugh, C.R. Thermal stability of vaccines. J. Pharm. Sci., 92, 218-31.
  • (2002) Rexroad, J., Wiethoff, C.M., Jones, L.S., Middaugh, C.R. Lyophilization and the thermal stability of vaccines. Cell Preservation Technology, 1, 91-104.
  • (2002) MacLean, D.S., Qian, Q. and Middaugh, C.R. "Stabilization of Proteins by Low Molecular Weight Multi-Ions." J. Pharm. Sci., 91, 2220-2229.
  • (2002) Souillac, P.O., Costantino, H.R., Middaugh, C.R. and Rytting, J.H. “Investigation on Protein/Carbohydrate Interactions in the Dried State. 1. Calorimetric Studies.” J. Pharm. Sci., 91, 206-216.
  • (2002) Tatulian, S.A., Chen, B., Li, J., Negash, S., Middaugh, C.R., Bigelow, D.J. and Squier, T.C. “Structural Interactions Between the Ca-ATPase and Phospholamban Identified by Attenuated Total Reflection FTIR Spectroscopy.” Biochemistry, 41, 741-751.
  • (2002) Lobo, B.A., Rogers, S.A., Choosakoonkriang, S., Bogdanowich-Knipp, S., Smith, J.G., Koe, G. and Middaugh, C.R. “Alteration of the Thermal Stability of Plasmid DNA by Cationic Lipids and Polymers.” J. Pharm. Sci., 91, 454-466.
  • (2002) Volkin, D.B., Sanyal, G., Burke, C.J. and Middaugh, C.R. “Preformulation Studies as an Essential Guide for Formulation Development and Manufacture of Protein Pharmaceuticals. Pharm. Biotech, Vol. 1-4, 1-46.
  • (2002) Huang, C.-Y., Ma, S.S., Lee, S., Radhakrishnau, R., Braun, C., Choosakoonkriang, S., Wiethoff, C., Lobo, B. and Middaugh, C.R. "Enhancements in Gene Expression of Plasmid DNA Formulations Containing Neutral Polymeric Excipients." J. Pharm. Sci., 91, 1371-1381.
  • (2001) Edwards, K.L.T., Kueltzo, L., Fisher, M.T. and Middaugh, C.R. “Complex Effects of Molecular Chaperones on the Aggregation and Refolding of Fibroblast Growth Factor-1, Arch. Biochem. Biophys., 393, 14-21.
  • (2001) Wiethoff, C.M., Smith, J.G., Koe, G.S. and Middaugh, C.R. “The Potential Role of Proteoglycans in Cationic-Lipid Mediated Gene Delivery: Studies of the Interaction of Cationic Lipid/DNA Complexes with Model Glucosaminoglycans”, J. Biol. Chem., 275, 32806-32813.
  • (2001) Choosakoonkriang, S., Wiethoff, C.M., Anchordoquy, T.J., Koe, G.S., Smith, J.G. and Middaugh, C.R. “Infrared Spectroscopic Characteristics of the Interactions of Cationic Lipids with Plasmid DNA.” J. Biol. Chem., 276, 8037-8043.
  • (2002) Souillac, P.O., Middaugh, C.R. and Rytting, J.H. “Investigation on Protein/Carbohydrate Interactions in the Dried State. 2. Diffuse Reflectance FTIR Studies.” Int. J. Pharm., 235, 207-218.
  • (2001) Harned, A.M., Probst, D.A., Sheriff, B.A., Poon, K.W.C., Hanson, P.R., Wiethoff, C.W. and Middaugh, C.R. “Ring Opening Metathesis Polymerization Strategies to Chemical and Biological Delivery Agents.” Polym, Prepr. (Am. Chem. Soc. Div. Polym. Chem.) 42, 143-144.
  • (2000) Kueltzo, L.A. and Middaugh, C.R. “Potential Use of Non-Classical Pathways for the Transport of Macromolecular Drugs.” Exp. Op. Invest. Drugs, 9, 2039-2050.
  • (2001) Tiyaboonchai, W., Woiszwillo, J. and Middaugh, C.R. “Formulation and Characterization of Amphotericin B-Polyethyleneimine-Dextran Sulfate Nanoparticles.” J. Pharm. Sci, 90, 902-914.
  • (2000) Kueltzo, L.A., O’Hare, P.O. and Middaugh, C.R. “Conformational Lability of Herpes Virus Protein VP22.” J. Biol. Chem., 275, 33213-33221.
  • (2001) Lobo, B.A., Koe, G., Smith, J.G. and Middaugh, C.R. “Isothermal Titration Calorimetric Analysis of the Interaction Between Cationic Lipids and Plasmid DNA.” Arch. Biochem. Biophys, 386, 95-105.
  • (2001) Grillo, A.O., Edwards, K.-L.T., Kashi, R.S., Shipley, K.M., Hu., L., Besman, M.J. and Middaugh, C.R. “Conformational Origin of the Aggregation of Recombinant Human Factor VIII.” Biochemistry, 40, 586-595.
  • (2001) Choosakoonkriang, S., Wiethoff, C., Kueltzo, L.A. and Middaugh, C.R. “Characterization of Synthetic Gene Delivery Vehicles by Infrared Spectroscopy.” Methods Molec. Med., 65, 285-317.
  • (2001) Lobo, B.A., Rogers, S.A., Wiethoff, C. “Characterization of Cationic Vector-Based Gene Delivery Vehicles Using Isothermal Titration and Differential Scanning Calorimetry.” Methods Molec. Med., 65, 319-348.
  • (2001) Wiethoff, C and Middaugh, C.R. “Light Scattering Techniques for the Characterization of Synthetic Gene Therapy Vectors.” Methods Molec. Med., 65, 349-376.
  • (2001) Braun, C.S., Kueltzo, L.A. and Middaugh, C.R. “Ultraviolet Absorption and Circular Dichroism Spectroscopy of Non-Viral Gene Delivery Complexes.” Methods Molec. Med., 65, 253-284.
Contact Information

Head, David B. Volkin PhD

2030 Becker Drive
Lawrence, KS 66047
volkin@ku.edu
785-864-6262

Director, Sangeeta B. Joshi PhD

2030 Becker Drive
Lawrence, KS 66047
joshi@ku.edu
785-864-3356

Scientific Advisor, C. Russell Middaugh PhD

2030 Becker Drive
Lawrence, KS 66047
middaugh@ku.edu
785-864-5813