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Items: 1 to 50 of 154

1.

Effect of aluminum adjuvant and preservatives on structural integrity and physicochemical stability profiles of three recombinant subunit rotavirus vaccine antigens.

Agarwal S, Hickey JM, McAdams D, White JA, Sitrin R, Khandke L, Cryz S, Joshi SB, Volkin DB.

J Pharm Sci. 2019 Oct 4. pii: S0022-3549(19)30638-0. doi: 10.1016/j.xphs.2019.10.004. [Epub ahead of print]

2.

Stabilization and formulation of a recombinant Human Cytomegalovirus vector for use as a candidate HIV-1 vaccine.

Kumru OS, Saleh-Birdjandi S, Antunez LR, Sayeed E, Robinson D, van den Worm S, Diemer GS, Perez W, Caposio P, Früh K, Joshi SB, Volkin DB.

Vaccine. 2019 Oct 16;37(44):6696-6706. doi: 10.1016/j.vaccine.2019.09.027. Epub 2019 Sep 20.

3.

Recombinant Subunit Rotavirus Trivalent Vaccine Candidate: Physicochemical Comparisons and Stability Evaluations of Three Protein Antigens.

Agarwal S, Hickey JM, Sahni N, Toth RT 4th, Robertson GA, Sitrin R, Cryz S, Joshi SB, Volkin DB.

J Pharm Sci. 2019 Aug 7. pii: S0022-3549(19)30495-2. doi: 10.1016/j.xphs.2019.08.002. [Epub ahead of print]

4.

Characterizing and Minimizing Aggregation and Particle Formation of Three Recombinant Fusion-Protein Bulk Antigens for Use in a Candidate Trivalent Rotavirus Vaccine.

Agarwal S, Sahni N, Hickey JM, Robertson GA, Sitrin R, Cryz S, Joshi SB, Volkin DB.

J Pharm Sci. 2019 Aug 7. pii: S0022-3549(19)30494-0. doi: 10.1016/j.xphs.2019.08.001. [Epub ahead of print]

5.

Preformulation Characterization and Stability Assessments of Secretory IgA Monoclonal Antibodies as Potential Candidates for Passive Immunization by Oral Administration.

Hu Y, Kumru OS, Xiong J, Antunez LR, Hickey J, Wang Y, Cavacini L, Klempner M, Joshi SB, Volkin DB.

J Pharm Sci. 2019 Jul 29. pii: S0022-3549(19)30453-8. doi: 10.1016/j.xphs.2019.07.018. [Epub ahead of print]

6.

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
7.

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
8.

Developability Assessment of Physicochemical Properties and Stability Profiles of HIV-1 BG505 SOSIP.664 and BG505 SOSIP.v4.1-GT1.1 gp140 Envelope Glycoprotein Trimers as Candidate Vaccine Antigens.

Whitaker N, Hickey JM, Kaur K, Xiong J, Sawant N, Cupo A, Lee WH, Ozorowski G, Medina-Ramírez M, Ward AB, Sanders RW, Moore JP, Joshi SB, Volkin DB, Dey AK.

J Pharm Sci. 2019 Jul;108(7):2264-2277. doi: 10.1016/j.xphs.2019.01.033. Epub 2019 Feb 15.

9.

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.

10.

Coformulation of Broadly Neutralizing Antibodies 3BNC117 and PGT121: Analytical Challenges During Preformulation Characterization and Storage Stability Studies.

Patel A, Gupta V, Hickey J, Nightlinger NS, Rogers RS, Siska C, Joshi SB, Seaman MS, Volkin DB, Kerwin BA.

J Pharm Sci. 2018 Dec;107(12):3032-3046. doi: 10.1016/j.xphs.2018.08.012. Epub 2018 Sep 1.

11.

Structural Changes and Aggregation Mechanisms of Two Different Dimers of an IgG2 Monoclonal Antibody.

Zhang J, Woods C, He F, Han M, Treuheit MJ, Volkin DB.

Biochemistry. 2018 Sep 18;57(37):5466-5479. doi: 10.1021/acs.biochem.8b00575. Epub 2018 Sep 5.

PMID:
30141909
12.

Physical Characterization and Stabilization of a Lentiviral Vector Against Adsorption and Freeze-Thaw.

Kumru OS, Wang Y, Gombotz CWR, Kelley-Clarke B, Cieplak W, Kim T, Joshi SB, Volkin DB.

J Pharm Sci. 2018 Nov;107(11):2764-2774. doi: 10.1016/j.xphs.2018.07.010. Epub 2018 Jul 12.

PMID:
30017889
13.

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.

14.

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
15.

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.

16.

Postproduction Handling and Administration of Protein Pharmaceuticals and Potential Instability Issues.

Nejadnik MR, Randolph TW, Volkin DB, Schöneich C, Carpenter JF, Crommelin DJA, Jiskoot W.

J Pharm Sci. 2018 Aug;107(8):2013-2019. doi: 10.1016/j.xphs.2018.04.005. Epub 2018 Apr 14.

PMID:
29665382
17.

Analytical Comparability Assessments of 5 Recombinant CRM197 Proteins From Different Manufacturers and Expression Systems.

Hickey JM, Toprani VM, Kaur K, Mishra RPN, Goel A, Oganesyan N, Lees A, Sitrin R, Joshi SB, Volkin DB.

J Pharm Sci. 2018 Jul;107(7):1806-1819. doi: 10.1016/j.xphs.2018.03.002. Epub 2018 Mar 8.

18.

Development of Stabilizing Formulations of a Trivalent Inactivated Poliovirus Vaccine in a Dried State for Delivery in the Nanopatch™ Microprojection Array.

Wan Y, Hickey JM, Bird C, Witham K, Fahey P, Forster A, Joshi SB, Volkin DB.

J Pharm Sci. 2018 Jun;107(6):1540-1551. doi: 10.1016/j.xphs.2018.01.027. Epub 2018 Feb 6.

19.

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
20.

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
21.

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.

22.

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
23.

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.

24.

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.

25.

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
26.

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.

27.

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.

28.

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.

29.

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.

30.

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.

31.

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
32.

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.

33.

Combined semi-empirical screening and design of experiments (DOE) approach to identify candidate formulations of a lyophilized live attenuated tetravalent viral vaccine candidate.

Patel A, Erb SM, Strange L, Shukla RS, Kumru OS, Smith L, Nelson P, Joshi SB, Livengood JA, Volkin DB.

Vaccine. 2018 May 24;36(22):3169-3179. doi: 10.1016/j.vaccine.2017.04.086. Epub 2017 May 12.

PMID:
28506515
34.

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
35.

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
36.

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.

Hickey JM, Sahni N, Chaudhuri R, D'Souza A, Metters A, Joshi SB, Russell Middaugh C, Volkin DB.

Protein Sci. 2017 Mar;26(3):527-535. doi: 10.1002/pro.3102. Epub 2017 Feb 12.

37.

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.

38.

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
39.

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
40.

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
41.

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
42.

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
43.

Evaluating the Role of the Air-Solution Interface on the Mechanism of Subvisible Particle Formation Caused by Mechanical Agitation for an IgG1 mAb.

Ghazvini S, Kalonia C, Volkin DB, Dhar P.

J Pharm Sci. 2016 May;105(5):1643-1656. doi: 10.1016/j.xphs.2016.02.027. Epub 2016 Mar 26.

PMID:
27025981
44.

Novel Ricin Subunit Antigens With Enhanced Capacity to Elicit Toxin-Neutralizing Antibody Responses in Mice.

Wahome N, Sully E, Singer C, Thomas JC, Hu L, Joshi SB, Volkin DB, Fang J, Karanicolas J, Jacobs DJ, Mantis NJ, Middaugh CR.

J Pharm Sci. 2016 May;105(5):1603-1613. doi: 10.1016/j.xphs.2016.02.009. Epub 2016 Mar 15.

45.

Site-Specific Hydrolysis Reaction C-Terminal of Methionine in Met-His during Metal-Catalyzed Oxidation of IgG-1.

Mozziconacci O, Arora J, Toth RT 4th, Joshi SB, Zhou S, Volkin DB, Schöneich C.

Mol Pharm. 2016 Apr 4;13(4):1317-28. doi: 10.1021/acs.molpharmaceut.5b00944. Epub 2016 Mar 11.

PMID:
26942274
46.

Improved Comparative Signature Diagrams to Evaluate Similarity of Storage Stability Profiles of Different IgG1 mAbs.

Kim JH, Joshi SB, Esfandiary R, Iyer V, Bishop SM, Volkin DB, Middaugh CR.

J Pharm Sci. 2016 Mar;105(3):1028-35. doi: 10.1016/j.xphs.2016.01.008. Epub 2016 Feb 9.

PMID:
26886311
47.

Biosimilarity Assessments of Model IgG1-Fc Glycoforms Using a Machine Learning Approach.

Kim JH, Joshi SB, Tolbert TJ, Middaugh CR, Volkin DB, Smalter Hall A.

J Pharm Sci. 2016 Feb;105(2):602-612. doi: 10.1016/j.xphs.2015.10.013. Epub 2015 Dec 30.

PMID:
26869422
48.

Correlating the Impact of Well-Defined Oligosaccharide Structures on Physical Stability Profiles of IgG1-Fc Glycoforms.

More AS, Toprani VM, Okbazghi SZ, Kim JH, Joshi SB, Middaugh CR, Tolbert TJ, Volkin DB.

J Pharm Sci. 2016 Feb;105(2):588-601. doi: 10.1016/j.xphs.2015.10.014. Epub 2015 Dec 30.

PMID:
26869421
49.

Comparative Evaluation of the Chemical Stability of 4 Well-Defined Immunoglobulin G1-Fc Glycoforms.

Mozziconacci O, Okbazghi S, More AS, Volkin DB, Tolbert T, Schöneich C.

J Pharm Sci. 2016 Feb;105(2):575-587. doi: 10.1016/j.xphs.2015.10.024. Epub 2016 Jan 11.

50.

Production, Characterization, and Biological Evaluation of Well-Defined IgG1 Fc Glycoforms as a Model System for Biosimilarity Analysis.

Okbazghi SZ, More AS, White DR, Duan S, Shah IS, Joshi SB, Middaugh CR, Volkin DB, Tolbert TJ.

J Pharm Sci. 2016 Feb;105(2):559-574. doi: 10.1016/j.xphs.2015.11.003. Epub 2016 Jan 9.

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