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Items: 1 to 50 of 361

1.

Cis/trans isomerization of unsaturated fatty acids in polysorbate 80 during light exposure of a monoclonal antibody-containing formulation.

Prajapati I, Peters BH, Larson NR, Wei Y, Choudhary S, Kalonia C, Hudak S, Esfandiary R, Middaugh CR, Schöneich C.

J Pharm Sci. 2019 Nov 9. pii: S0022-3549(19)30744-0. doi: 10.1016/j.xphs.2019.10.068. [Epub ahead of print]

PMID:
31715179
2.

Effects of glycan structure on the stability and receptor binding of an IgG4-Fc.

Kang H, Larson NR, White DR, Middaugh CR, Tolbert T, Schöneich C.

J Pharm Sci. 2019 Oct 25. pii: S0022-3549(19)30673-2. doi: 10.1016/j.xphs.2019.10.036. [Epub ahead of print]

PMID:
31669606
3.

Effect of Iron Oxide Nanoparticles on the Oxidation and Secondary Structure of Growth Hormone.

Varkhede N, Peters BH, Wei Y, Middaugh CR, Schöneich C, Forrest ML.

J Pharm Sci. 2019 Oct;108(10):3372-3381. doi: 10.1016/j.xphs.2019.06.007. Epub 2019 Jun 16.

PMID:
31216451
4.

Characterization of Excipient Effects on Reversible Self-Association, Backbone Flexibility, and Solution Properties of an IgG1 Monoclonal Antibody at High Concentrations: Part 1.

Hu Y, Arora J, Joshi SB, Esfandiary R, Middaugh CR, Weis DD, Volkin DB.

J Pharm Sci. 2019 Jun 13. pii: S0022-3549(19)30373-9. doi: 10.1016/j.xphs.2019.06.005. [Epub ahead of print]

PMID:
31201906
5.

The cytoplasmic portion of the T3SS inner membrane ring components sort into distinct families based on biophysical properties.

Muthuramalingam M, Middaugh CR, Picking WD.

Biochim Biophys Acta Proteins Proteom. 2019 Sep;1867(9):787-793. doi: 10.1016/j.bbapap.2019.06.002. Epub 2019 Jun 10.

PMID:
31195141
6.

Characterization of Excipient Effects on Reversible Self-Association, Backbone Flexibility, and Solution Properties of an IgG1 Monoclonal Antibody at High Concentrations: Part 2.

Hu Y, Toth RT 4th, Joshi SB, Esfandiary R, Middaugh CR, Volkin DB, Weis DD.

J Pharm Sci. 2019 Jun 11. pii: S0022-3549(19)30368-5. doi: 10.1016/j.xphs.2019.06.001. [Epub ahead of print]

PMID:
31195015
7.

A Collection of Single-Domain Antibodies that Crowd Ricin Toxin's Active Site.

Angalakurthi SK, Vance DJ, Rong Y, Nguyen CMT, Rudolph MJ, Volkin D, Middaugh CR, Weis DD, Mantis NJ.

Antibodies (Basel). 2018 Dec;7(4). pii: 45. doi: 10.3390/antib7040045. Epub 2018 Dec 17.

8.

Fine-Specificity Epitope Analysis Identifies Contact Points on Ricin Toxin Recognized by Protective Monoclonal Antibodies.

Van Slyke G, Angalakurthi SK, Toth RT 4th, Vance DJ, Rong Y, Ehrbar D, Shi Y, Middaugh CR, Volkin DB, Weis DD, Mantis NJ.

Immunohorizons. 2018 Sep;2(8):262-273. doi: 10.4049/immunohorizons.1800042.

9.

Developing Biologics Tablets: The Effects of Compression on the Structure and Stability of Bovine Serum Albumin and Lysozyme.

Wei Y, Wang C, Jiang B, Sun CC, Middaugh CR.

Mol Pharm. 2019 Mar 4;16(3):1119-1131. doi: 10.1021/acs.molpharmaceut.8b01118. Epub 2019 Feb 18.

PMID:
30698973
10.

Soluble Antigen Arrays for Selective Desensitization of Insulin-Reactive B Cells.

Leon MA, Wemlinger SM, Larson NR, Ruffalo JK, Sestak JO, Middaugh CR, Cambier JC, Berkland C.

Mol Pharm. 2019 Apr 1;16(4):1563-1572. doi: 10.1021/acs.molpharmaceut.8b01250. Epub 2019 Feb 25.

PMID:
30681867
11.

Glatiramer acetate persists at the injection site and draining lymph nodes via electrostatically-induced aggregation.

Song JY, Larson NR, Thati S, Torres-Vazquez I, Martinez-Rivera N, Subelzu NJ, Leon MA, Rosa-Molinar E, Schöneich C, Forrest ML, Middaugh CR, Berkland CJ.

J Control Release. 2019 Jan 10;293:36-47. doi: 10.1016/j.jconrel.2018.11.007. Epub 2018 Nov 7.

PMID:
30414463
12.

Contribution of an unusual CDR2 element of a single domain antibody in ricin toxin binding affinity and neutralizing activity.

Rudolph MJ, Vance DJ, Kelow S, Angalakurthi SK, Nguyen S, Davis SA, Rong Y, Middaugh CR, Weis DD, Dunbrack R Jr, Karanicolas J, Mantis NJ.

Protein Eng Des Sel. 2018 Jul 1;31(7-8):277-287. doi: 10.1093/protein/gzy022.

13.

Forecasting effects of angler harvest and climate change on smallmouth bass abundance at the southern edge of their range.

Middaugh CR, Magoulick DD.

PLoS One. 2018 Aug 20;13(8):e0202737. doi: 10.1371/journal.pone.0202737. eCollection 2018.

14.

Effect of 2 Emulsion-Based Adjuvants on the Structure and Thermal Stability of Staphylococcus aureus Alpha-Toxin.

Wei Y, Xiong J, Larson NR, Iyer V, Sanyal G, Joshi SB, Volkin DB, Middaugh CR.

J Pharm Sci. 2018 Sep;107(9):2325-2334. doi: 10.1016/j.xphs.2018.05.019. Epub 2018 Jun 6.

15.

Structural Characterization and Formulation Development of a Trivalent Equine Encephalitis Virus-Like Particle Vaccine Candidate.

Toprani VM, Cheng Y, Wahome N, Khasa H, Kueltzo LA, Schwartz RM, Middaugh CR, Joshi SB, Volkin DB.

J Pharm Sci. 2018 Oct;107(10):2544-2558. doi: 10.1016/j.xphs.2018.05.022. Epub 2018 Jun 5.

PMID:
29883665
16.

Biomedical Applications of Lumazine Synthase.

Wei Y, Kumar P, Wahome N, Mantis NJ, Middaugh CR.

J Pharm Sci. 2018 Sep;107(9):2283-2296. doi: 10.1016/j.xphs.2018.05.002. Epub 2018 May 12. Review.

PMID:
29763607
17.

Impact of Glycosylation on the Local Backbone Flexibility of Well-Defined IgG1-Fc Glycoforms Using Hydrogen Exchange-Mass Spectrometry.

More AS, Toth RT 4th, Okbazghi SZ, Middaugh CR, Joshi SB, Tolbert TJ, Volkin DB, Weis DD.

J Pharm Sci. 2018 Sep;107(9):2315-2324. doi: 10.1016/j.xphs.2018.04.026. Epub 2018 May 8.

18.

Self-Assembled Coacervates of Chitosan and an Insect Cuticle Protein Containing a Rebers-Riddiford Motif.

Vaclaw MC, Sprouse PA, Dittmer NT, Ghazvini S, Middaugh CR, Kanost MR, Gehrke SH, Dhar P.

Biomacromolecules. 2018 Jul 9;19(7):2391-2400. doi: 10.1021/acs.biomac.7b01637. Epub 2018 May 9.

PMID:
29697975
19.

Investigating the dynamics and polyanion binding sites of fibroblast growth factor-1 using hydrogen-deuterium exchange mass spectrometry.

Angalakurthi SK, Tenorio CA, Blaber M, Middaugh CR.

Protein Sci. 2018 Jun;27(6):1068-1082. doi: 10.1002/pro.3423. Epub 2018 May 3.

20.

Label-Free, Direct Measurement of Protein Concentrations in Turbid Solutions with a UV-Visible Integrating Cavity Absorbance Spectrometer.

Larson NR, Wei Y, Middaugh CR.

Anal Chem. 2018 Apr 17;90(8):4982-4986. doi: 10.1021/acs.analchem.8b00502. Epub 2018 Mar 30.

PMID:
29565565
21.

Characterization and Protective Efficacy of Type III Secretion Proteins as a Broadly Protective Subunit Vaccine against Salmonella enterica Serotypes.

Martinez-Becerra FJ, Kumar P, Vishwakarma V, Kim JH, Arizmendi O, Middaugh CR, Picking WD, Picking WL.

Infect Immun. 2018 Feb 20;86(3). pii: e00473-17. doi: 10.1128/IAI.00473-17. Print 2018 Mar.

22.

Evaluation of Hydrogen Exchange Mass Spectrometry as a Stability-Indicating Method for Formulation Excipient Screening for an IgG4 Monoclonal Antibody.

Toth RT 4th, Pace SE, Mills BJ, Joshi SB, Esfandiary R, Middaugh CR, Weis DD, Volkin DB.

J Pharm Sci. 2018 Apr;107(4):1009-1019. doi: 10.1016/j.xphs.2017.12.009. Epub 2017 Dec 18.

PMID:
29269271
23.

Correction to Empirical Correction for Differences in Chemical Exchange Rates in Hydrogen Exchange-Mass Spectrometry Measurements.

Toth RT 4th, Mills BJ, Joshi SB, Esfandiary R, Bishop SM, Middaugh CR, Volkin DB, Weis DD.

Anal Chem. 2017 Dec 19;89(24):13673. doi: 10.1021/acs.analchem.7b04690. Epub 2017 Dec 6. No abstract available.

PMID:
29210567
24.

High-Definition Mapping of Four Spatially Distinct Neutralizing Epitope Clusters on RiVax, a Candidate Ricin Toxin Subunit Vaccine.

Toth RT 4th, Angalakurthi SK, Van Slyke G, Vance DJ, Hickey JM, Joshi SB, Middaugh CR, Volkin DB, Weis DD, Mantis NJ.

Clin Vaccine Immunol. 2017 Dec 5;24(12). pii: e00237-17. doi: 10.1128/CVI.00237-17. Print 2017 Dec.

25.

Effect of Phosphate Ion on the Structure of Lumazine Synthase, an Antigen Presentation System From Bacillus anthracis.

Wei Y, Wahome N, Kumar P, Whitaker N, Picking WL, Middaugh CR.

J Pharm Sci. 2018 Mar;107(3):814-823. doi: 10.1016/j.xphs.2017.10.013. Epub 2017 Oct 16.

PMID:
29045884
26.

The Use of a GroEL-BLI Biosensor to Rapidly Assess Preaggregate Populations for Antibody Solutions Exhibiting Different Stability Profiles.

Pace SE, Joshi SB, Esfandiary R, Stadelman R, Bishop SM, Middaugh CR, Fisher MT, Volkin DB.

J Pharm Sci. 2018 Feb;107(2):559-570. doi: 10.1016/j.xphs.2017.10.010. Epub 2017 Oct 14.

PMID:
29037466
27.

High-Resolution Epitope Positioning of a Large Collection of Neutralizing and Nonneutralizing Single-Domain Antibodies on the Enzymatic and Binding Subunits of Ricin Toxin.

Vance DJ, Tremblay JM, Rong Y, Angalakurthi SK, Volkin DB, Middaugh CR, Weis DD, Shoemaker CB, Mantis NJ.

Clin Vaccine Immunol. 2017 Dec 5;24(12). pii: e00236-17. doi: 10.1128/CVI.00236-17. Print 2017 Dec.

28.

Structural Characterization and Physicochemical Stability Profile of a Double Mutant Heat Labile Toxin Protein Based Adjuvant.

Toprani VM, Hickey JM, Sahni N, Toth RT 4th, Robertson GA, Middaugh CR, Joshi SB, Volkin DB.

J Pharm Sci. 2017 Dec;106(12):3474-3485. doi: 10.1016/j.xphs.2017.07.019. Epub 2017 Aug 2.

29.

Empirical Correction for Differences in Chemical Exchange Rates in Hydrogen Exchange-Mass Spectrometry Measurements.

Toth RT 4th, Mills BJ, Joshi SB, Esfandiary R, Bishop SM, Middaugh CR, Volkin DB, Weis DD.

Anal Chem. 2017 Sep 5;89(17):8931-8941. doi: 10.1021/acs.analchem.7b01396. Epub 2017 Aug 11. Erratum in: Anal Chem. 2017 Dec 19;89(24):13673.

PMID:
28753295
30.

Comparative Characterization of Crofelemer Samples Using Data Mining and Machine Learning Approaches With Analytical Stability Data Sets.

Nariya MK, Kim JH, Xiong J, Kleindl PA, Hewarathna A, Fisher AC, Joshi SB, Schöneich C, Forrest ML, Middaugh CR, Volkin DB, Deeds EJ.

J Pharm Sci. 2017 Nov;106(11):3270-3279. doi: 10.1016/j.xphs.2017.07.013. Epub 2017 Jul 22.

31.

The Botanical Drug Substance Crofelemer as a Model System for Comparative Characterization of Complex Mixture Drugs.

Kleindl PA, Xiong J, Hewarathna A, Mozziconacci O, Nariya MK, Fisher AC, Deeds EJ, Joshi SB, Middaugh CR, Schöneich C, Volkin DB, Forrest ML.

J Pharm Sci. 2017 Nov;106(11):3242-3256. doi: 10.1016/j.xphs.2017.07.012. Epub 2017 Jul 22.

32.

Evaluation of lumazine synthase from Bacillus anthracis as a presentation platform for polyvalent antigen display.

Wei Y, Wahome N, VanSlyke G, Whitaker N, Kumar P, Barta ML, Picking WL, Volkin DB, Mantis NJ, Middaugh CR.

Protein Sci. 2017 Oct;26(10):2059-2072. doi: 10.1002/pro.3243. Epub 2017 Sep 13.

33.

Using homology modeling to interrogate binding affinity in neutralization of ricin toxin by a family of single domain antibodies.

Bazzoli A, Vance DJ, Rudolph MJ, Rong Y, Angalakurthi SK, Toth RT 4th, Middaugh CR, Volkin DB, Weis DD, Karanicolas J, Mantis NJ.

Proteins. 2017 Nov;85(11):1994-2008. doi: 10.1002/prot.25353. Epub 2017 Aug 4.

34.

Chemical Stability of the Botanical Drug Substance Crofelemer: A Model System for Comparative Characterization of Complex Mixture Drugs.

Hewarathna A, Mozziconacci O, Nariya MK, Kleindl PA, Xiong J, Fisher AC, Joshi SB, Middaugh CR, Forrest ML, Volkin DB, Deeds EJ, Schöneich C.

J Pharm Sci. 2017 Nov;106(11):3257-3269. doi: 10.1016/j.xphs.2017.06.022. Epub 2017 Jul 5.

35.

A Formulation Development Approach to Identify and Select Stable Ultra-High-Concentration Monoclonal Antibody Formulations With Reduced Viscosities.

Whitaker N, Xiong J, Pace SE, Kumar V, Middaugh CR, Joshi SB, Volkin DB.

J Pharm Sci. 2017 Nov;106(11):3230-3241. doi: 10.1016/j.xphs.2017.06.017. Epub 2017 Jun 28.

PMID:
28668340
36.

Development of a candidate stabilizing formulation for bulk storage of a double mutant heat labile toxin (dmLT) protein based adjuvant.

Toprani VM, Sahni N, Hickey JM, Robertson GA, Middaugh CR, Joshi SB, Volkin DB.

Vaccine. 2017 Oct 4;35(41):5471-5480. doi: 10.1016/j.vaccine.2017.03.101. Epub 2017 May 24.

37.

Correlating the Effects of Antimicrobial Preservatives on Conformational Stability, Aggregation Propensity, and Backbone Flexibility of an IgG1 mAb.

Arora J, Joshi SB, Middaugh CR, Weis DD, Volkin DB.

J Pharm Sci. 2017 Jun;106(6):1508-1518. doi: 10.1016/j.xphs.2017.02.007. Epub 2017 Feb 14.

PMID:
28212986
38.

Preformulation Characterization, Stabilization, and Formulation Design for the Acrylodan-Labeled Glucose-Binding Protein SM4-AC.

Sahni N, Chaudhuri R, Hickey JM, Manikwar P, D'Souza A, Metters A, Joshi SB, Middaugh CR, Volkin DB.

J Pharm Sci. 2017 May;106(5):1197-1210. doi: 10.1016/j.xphs.2017.01.004. Epub 2017 Jan 11.

PMID:
28088457
39.

Charge-mediated Fab-Fc interactions in an IgG1 antibody induce reversible self-association, cluster formation, and elevated viscosity.

Arora J, Hu Y, Esfandiary R, Sathish HA, Bishop SM, Joshi SB, Middaugh CR, Volkin DB, Weis DD.

MAbs. 2016 Nov/Dec;8(8):1561-1574. Epub 2016 Aug 25.

40.

An S116R Phosphorylation Site Mutation in Human Fibroblast Growth Factor-1 Differentially Affects Mitogenic and Glucose-Lowering Activities.

Xia X, Kumru OS, Blaber SI, Middaugh CR, Li L, Ornitz DM, Suh JM, Atkins AR, Downes M, Evans RM, Tenorio CA, Bienkiewicz E, Blaber M.

J Pharm Sci. 2016 Dec;105(12):3507-3519. doi: 10.1016/j.xphs.2016.09.005. Epub 2016 Oct 20.

41.

Overcoming formulation challenges for the next generation of vaccines.

Berkland C, Middaugh CR.

Expert Opin Drug Deliv. 2016 Nov;13(11):1501-1502. Epub 2016 Sep 21. No abstract available.

PMID:
27636031
42.

Publisher's Note: "Permeation of the three aromatic dipeptides through lipid bilayers: Experimental and computational study" [J. Chem. Phys. 144, 245103 (2016)].

Lee BL, Kuczera K, Middaugh CR, Jas GS.

J Chem Phys. 2016 Aug 7;145(5):059902. doi: 10.1063/1.4960183. No abstract available.

PMID:
27497582
43.

Effects of Protein Conformation, Apparent Solubility, and Protein-Protein Interactions on the Rates and Mechanisms of Aggregation for an IgG1Monoclonal Antibody.

Kalonia C, Toprani V, Toth R, Wahome N, Gabel I, Middaugh CR, Volkin DB.

J Phys Chem B. 2016 Jul 28;120(29):7062-75. doi: 10.1021/acs.jpcb.6b03878. Epub 2016 Jul 14.

PMID:
27380437
44.

Permeation of the three aromatic dipeptides through lipid bilayers: Experimental and computational study.

Lee BL, Kuczera K, Middaugh CR, Jas GS.

J Chem Phys. 2016 Jun 28;144(24):245103. doi: 10.1063/1.4954241.

PMID:
27369545
45.

A Micro-Polyethylene Glycol Precipitation Assay as a Relative Solubility Screening Tool for Monoclonal Antibody Design and Formulation Development.

Toprani VM, Joshi SB, Kueltzo LA, Schwartz RM, Middaugh CR, Volkin DB.

J Pharm Sci. 2016 Aug;105(8):2319-27. doi: 10.1016/j.xphs.2016.05.021. Epub 2016 Jun 29.

PMID:
27368120
46.

Probing Selection Mechanism of the Most Favorable Conformation of a Dipeptide in Chaotropic and Kosmotropic Solution.

Jas GS, Middaugh CR, Kuczera K.

J Phys Chem B. 2016 Jul 21;120(28):6939-50. doi: 10.1021/acs.jpcb.6b04528. Epub 2016 Jul 7.

PMID:
27328987
47.

Production of Well-Characterized Virus-like Particles in an Escherichia coli-Based Expression Platform for Preclinical Vaccine Assessments.

Wahome N, Cooper A, Thapa P, Choudhari S, Gao FP, Volkin DB, Middaugh CR.

Methods Mol Biol. 2016;1404:437-57. doi: 10.1007/978-1-4939-3389-1_29.

PMID:
27076315
48.

Formulation Studies During Preclinical Development of Influenza Hemagglutinin and Virus-Like Particle Vaccine Candidates.

Wahome N, Hickey JM, Volkin DB, Middaugh CR.

Methods Mol Biol. 2016;1404:393-421. doi: 10.1007/978-1-4939-3389-1_27.

PMID:
27076313
49.

Challenges and opportunities of using liquid chromatography and mass spectrometry methods to develop complex vaccine antigens as pharmaceutical dosage forms.

Hickey JM, Sahni N, Toth RT 4th, Kumru OS, Joshi SB, Middaugh CR, Volkin DB.

J Chromatogr B Analyt Technol Biomed Life Sci. 2016 Oct 1;1032:23-38. doi: 10.1016/j.jchromb.2016.04.001. Epub 2016 Apr 4. Review.

PMID:
27071526
50.

Engineering a Cysteine-Free Form of Human Fibroblast Growth Factor-1 for "Second Generation" Therapeutic Application.

Xia X, Kumru OS, Blaber SI, Middaugh CR, Li L, Ornitz DM, Sutherland MA, Tenorio CA, Blaber M.

J Pharm Sci. 2016 Apr;105(4):1444-53. doi: 10.1016/j.xphs.2016.02.010.

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