Publications

Complete Publications List - Macromolecule and Vaccine Stabilization Center

PubMed Articles for MVSC Directors:

CR Middaugh | DB Volkin | SB Joshi

Selected Publications from the MVSC:

2018

  • Kumru OS, Wang Y, Gombotz CWR, Kelley-Clarke B, Cieplak W, Kim T, Joshi SB, Volkin DB. Physical characterization and stabilization of a lentiviral vector against adsorption and freeze-thaw. J Pharm Sci. 2018 Jul 12.
  • Toprani VM, Cheng Y, Wahome N, Khasa H, Kueltzo LA, Schwartz RM, Middaugh CR, Joshi SB, Volkin DB. Structural Characterization and Formulation Development of a Trivalent Equine Encephalitis Virus-Like Particle Vaccine Candidate. J Pharm Sci. 2018 Jun 5. pii: S0022-3549(18)30327-7.
  • Hickey JM, Toprani VM, Kaur K, Mishra RPN, Goel A, Oganesyan N, Lees A, Sitrin R, Joshi SB, Volkin DB. Analytical Comparability Assessments of 5 Recombinant CRM(197) Proteins From Different Manufacturers and Expression Systems. J Pharm Sci. 2018 Jul;107(7):1806-1819.
  • Nejadnik MR, Randolph TW, Volkin DB, Schöneich C, Carpenter JF, Crommelin DJ, Jiskoot W. “Postproduction Handling and Administration of Protein Pharmaceuticals and Potential Instability Issues.”  J. Pharm Sci. 107(8):2013-2019 (2018)
  • Wei Y, Xiong J, Larson NR, Iyer V, Sanyal G, Joshi SB, Volkin DB, Middaugh CR. “Effect of Two Emulsion-Based Adjuvants on the Structure and Thermal Stability of S. aureus Alpha-toxin. Journal of pharmaceutical sciences.” J. Pharm Sci. 107(9):2325-2334 (2018)
  • More AS, Toth RT, Okbazghi SZ, Middaugh CR, Joshi SB, Tolbert TJ, Volkin DB, Weis DD. “Impact of Glycosylation on the Local Backbone Flexibility of Well-Defined IgG1-Fc Glycoforms Using Hydrogen Exchange-Mass Spectrometry (HX-MS)” J. Pharm Sci. 107(9) 2315-2324 (2018)
  • Hickey JM, Toprani VM, Kaur K, Mishra RP, Goel A, Oganesyan N, Lees A, Sitrin R, Joshi SB, Volkin DB. “Analytical comparability assessments of five recombinant CRM197 proteins from different manufacturers and expression systems.” J Pharm Sci. 107(7) 1806-1819 (2018)
  • Patel A, Erb SM, Strange L, Shukla RS, Kumru O, Smith L, Nelson P, Joshi SB, Livengood JA, Volkin DB. “Combined semi-empirical screening and design of experiments (DOE) approach to identify candidate formulations of a lyophilized live attenuated tetravalent viral vaccine candidate” Vaccine 36: 3169-3179 (2018)
  • Pace SE, Joshi SB, Esfandiary R, Stadelman R, Bishop SM, Middaugh CR, Fisher M, Volkin DB “The use of a GroEL-BLI biosensor to rapidly assess pre-aggregate populations for antibody solutions exhibiting different stability profiles” J Pharm Sci. 107(2):559-570  (2018) 
  • Toth RT, Pace SE, Mills BJ, Joshi SB, Esfandiary R, Middaugh CR, Weis DD, Volkin DB. “Evaluation of Hydrogen Exchange Mass Spectrometry as a Stability-Indicating Method for Formulation Excipient Screening for an IgG4 Monoclonal Antibody” J Pharm Sci. 107(4):1009-1019 (2018) 
  • Wan Y, Hickey JM, Bird C, Witham K, Fahey P, Forster A, Joshi SB, Volkin DB. “Development of stabilizing formulations of a trivalent inactivated poliovirus vaccine in a dried state for delivery in the Nanopatch TM Microprojection Array” J Pharm Sci. 107(6):1540-1551 

2017

  • Vance DJ, Tremblay JM, Rong Y, Angalakurthi SK, Volkin DB, Middaugh CR, Weis DD, Shoemaker CB, Mantis NJ “High-resolution epitope positioning of a large collection of neutralizing and non-neutralizing single domain antibodies on ricin toxin's enzymatic and binding subunits” Clin Vaccine Immunol 24(12) (2017)
  • Toth R, Angalakurthi SK, Van Slyke G, Vance DJ, Hickey JM, Joshi SB, Middaugh CR, Volkin DB, Weis DD, Mantis NJ “High-Definition mapping of four spatially distinct neutralizing epitope elusters on RiVax, a candidate ricin toxin subunit vaccine” Clin Vaccine Immunol 2017 Dec 5; 24(12) (2017)
  • Kleindl PA, Xiong J, Hewarathna A, Mozziconacci O, Nariya MK, Fisher AC, Deeds EJ, Joshi SB, Middaugh CR, Schöneich C, Volkin DB, Forrest L, “The botanical drug substance crofelemer as a model system for comparative characterization of complex mixture drugs” J Pharm Sci 106 (11): 3242-3256 (2017)
  • Toprani VM, Sahni N, Hickey JM, Robertson GA, Middaugh CR, Joshi SB, Volkin DB. Development of a candidate stabilizing formulation for bulk storage of a double mutant heat labile toxin (dmLT) protein based adjuvant. Vaccine.106(12) 3474-3485 (2017).
  • Whitaker N, Xiong J, Pace SE, Kumar V, Middaugh CR, Joshi SB, Volkin DB. A Formulation Development Approach to Identify and Select Stable Ultra-High Concentration Monoclonal Antibody Formulations with Reduced Viscosities. J Pharm  Sci. 106 (11): 3230-3241 (2017).
  • Hewarathna A, Mozziconacci O, Nariya MK, Kleindl PA, Xiong J, Fisher AC, Joshi SB, Middaugh CR, Forrest ML, Volkin DB, Deeds EJ, Schöneich C. Chemical stability of the botanical drug substance Crofelemer: a model system for comparative characterization of complex mixture drugs. J Pharm Sci. 106 (11): 3257-3269 (2017).
  • Bazzoli A, Vance DJ, Rudolph MJ, Rong Y, Angalakurthi SK, Toth RT 4th, Middaugh CR, Volkin DB, Weis DD, Karanicolas J, Mantis NJ. Using Homology Modeling to Interrogate Binding Affinity in Neutralization of Ricin Toxin by a Family of Single Domain Antibodies. Proteins. 85(11):1994-2008 (2017).
  • Wei Y, Wahome N, VanSlyke G, Whitaker N, Kumar P, Barta ML, Picking WL, Volkin DB, Mantis NJ, Middaugh CR. Evaluation of Lumazine Synthase from Bacillus anthracis as a Presentation Platform for Polyvalent Antigen Display. Protein Sci. 26(10):2059-2072 (2017).
  • Kleindl PA, Xiong J, Hewarathna A, Mozziconacci O, Nariya MK, Fisher AC, Deeds EJ, Joshi SB, Middaugh CR, Schöneich C, Volkin DB, Forrest ML. The botanical drug substance crofelemer as a model system for comparative characterization of complex mixture drugs. J Pharm Sci. 2017 Jul 22.
  • Nariya MK, Kim JH, Xiong J, Kleindl PA, Hewarathna A, Fisher AC, Joshi SB, Schöneich C, Forrest ML, Middaugh CR, Volkin DB, Deeds EJ. Comparative Characterization of Crofelemer Samples using Data Mining and Machine Learning Approaches with Analytical Stability Data Sets. J Pharm Sci. 106 (11) 3270-3279 (2017).
  • Toth Iv RT, Mills BJ, Joshi SB, Esfandiary R, Bishop SM, Middaugh CR, Volkin DB, Weis DD. An Empirical Correction for Differences in Chemical Exchange Rates in Hydrogen Exchange Mass Spectrometry Measurements. Anal Chem. 89(17): 8931-8941 (2017).
  • Patel A, Erb SM, Strange L, Shukla RS, Kumru OS, Smith L, Nelson P, Joshi SB,Livengood JA, Volkin DB. Combined semi-empirical screening and design of experiments (DOE) approach to identify candidate formulations of a lyophilized live attenuated tetravalent viral vaccine candidate. Vaccine. 2017 May 12.
  • 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 106 (6): 1508-1518 (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. 106 (5):1197-1210 (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.