D. Volkin

D. Volkin, Hanns‐Christian Mahler, T. Werk, 2014, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

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

S. Joshi, D. Volkin, D. Weis, 2018, Journal of pharmaceutical sciences.

Comparative evaluation of the chemical stability of four well-defined IgG1 Fc glycoforms

D. Volkin, C. Schöneich, Olivier Mozziconacci, 2016 .

Development of a microflow digital imaging assay to characterize protein particulates during storage of a high concentration IgG1 monoclonal antibody formulation.

D. Volkin, P. Dalmonte, K. Wuchner, 2010, Journal of pharmaceutical sciences.

High throughput prediction of the long-term stability of pharmaceutical macromolecules from short-term multi-instrument spectroscopic data.

Vidyashankara G. Iyer, G. Winter, S. Joshi, 2014, Journal of pharmaceutical sciences.

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

S. Joshi, D. Volkin, J. Hickey, 2018, Journal of pharmaceutical sciences.

Circular dichroism of peptides.

D. Volkin, M. R. Liyanage, C. Middaugh, 2014, Methods in molecular biology.

Investigation of protein conformational stability employing a multimodal spectrometer.

S. Joshi, D. Volkin, Lei Hu, 2011, Analytical chemistry.

Effect of polyanions on the unfolding of acidic fibroblast growth factor.

D. Volkin, H. Mach, C. J. Burke, 1993, Biochemistry.

Enhancement of DNA vaccine potency using conventional aluminum adjuvants.

R. K. Evans, W. Mcclements, D. Volkin, 1999, Vaccine.

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

S. Joshi, D. Volkin, J. Hickey, 2016, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Stabilization of human papillomavirus virus-like particles by non-ionic surfactants.

D. Volkin, A. Ni, Zheng Luo, 2005, Journal of pharmaceutical sciences.

Stabilization of the FK506 binding protein by ligand binding.

G. Sanyal, D. Volkin, H. Chan, 1991, Biochemical and Biophysical Research Communications - BBRC.

Biophysical characterization and conformational stability of Ebola and Marburg virus-like particles.

S. Joshi, D. Volkin, J. Trefethen, 2011, Journal of pharmaceutical sciences.

Antigen-adjuvant interactions, stability, and immunogenicity profiles of a SARS-CoV-2 receptor-binding domain (RBD) antigen formulated with aluminum salt and CpG adjuvants

Neil C. Dalvie, J. C. Love, K. Kaur, 2022, Human vaccines & immunotherapeutics.

Fourier transform infrared spectroscopy of peptides.

D. Volkin, M. R. Liyanage, C. Middaugh, 2014, Methods in molecular biology.

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

K. Kaur, S. Joshi, D. Volkin, 2018, Journal of pharmaceutical sciences.

Understanding the relevance of local conformational stability and dynamics to the aggregation propensity of an IgG1 and IgG2 monoclonal antibodies

Santosh V. Thakkar, S. Joshi, D. Volkin, 2013, Protein science : a publication of the Protein Society.

Prophylactic Activity of Orally Administered FliD-Reactive Monoclonal SIgA Against Campylobacter Infection

S. Joshi, D. Volkin, F. Seehusen, 2020, Frontiers in Immunology.

Interaction of nucleotides with acidic fibroblast growth factor (FGF-1).

D. Volkin, M. Bruner, A. Verticelli, 1994, Biochemistry.

Physical characterization and formulation development of a recombinant pneumolysoid protein-based pneumococcal vaccine.

S. Joshi, D. Volkin, Lei Hu, 2013, Journal of pharmaceutical sciences.

Biophysical characterization and immunization studies of dominant negative inhibitor (DNI), a candidate anthrax toxin subunit vaccine

Vidyashankara G. Iyer, S. Joshi, D. Volkin, 2013, Human vaccines & immunotherapeutics.

Hydrogen-deuterium exchange mass spectrometry as an emerging analytical tool for stabilization and formulation development of therapeutic monoclonal antibodies.

D. Volkin, D. Weis, R. Majumdar, 2015, Journal of pharmaceutical sciences.

Fluorescence spectroscopy of peptides.

D. Volkin, M. R. Liyanage, C. Middaugh, 2014, Methods in molecular biology.

Linking the solution viscosity of an IgG2 monoclonal antibody to its structure as a function of pH and temperature.

C Russell Middaugh, Sangeeta B Joshi, David B Volkin, 2013, Journal of pharmaceutical sciences.

Molecular engineering of a cryptic epitope in Spike RBD improves manufacturability and neutralizing breadth against SARS-CoV-2 variants

Neil C. Dalvie, J. C. Love, Sergio A. Rodriguez-Aponte, 2022, bioRxiv.

Analytical and Preformulation Characterization Studies of Human Papillomavirus Virus-Like Particles to Enable Quadrivalent Multi-Dose Vaccine Formulation Development.

S. Joshi, D. Volkin, S. Brendle, 2022, Journal of pharmaceutical sciences.

Analytical characterization and formulation assessment of model secretory- immunoglobulin-A (sIgAs) for their potential use as low cost, orally delivered sIgAs

M. Klempner, L. Cavacini, S. Joshi, 2018 .

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

D. Volkin, N. Mantis, C. Shoemaker, 2017, Clinical and Vaccine Immunology.

High-Resolution Epitope Positioning of a Large Collection of Neutralizing and Non-Neutralizing Single Domain Antibodies on Ricin Toxin's Enzymatic and Binding Subunits

D. Volkin, N. Mantis, C. Shoemaker, 2017 .

Biophysical and formulation studies of the Schistosoma mansoni TSP-2 extracellular domain recombinant protein, a lead vaccine candidate antigen for intestinal schistosomiasis

P. Hotez, S. Joshi, D. Volkin, 2013, Human vaccines & immunotherapeutics.

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

Vidyashankara G. Iyer, S. Joshi, D. Volkin, 2018, Journal of pharmaceutical sciences.

Effect of Two Emulsion-Based Adjuvants on the Structure and Thermal Stability of S. aureus Alpha-toxin

Vidyashankara G. Iyer, S. Joshi, D. Volkin, 2018 .

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

A. Metters, S. Joshi, D. Volkin, 2017, Protein science : a publication of the Protein Society.

Degradative covalent reactions important to protein stability

D. Volkin, H. Mach, C. Middaugh, 1997, Molecular biotechnology.

Ultraviolet absorption spectroscopy of peptides.

D. Volkin, M. R. Liyanage, C. Middaugh, 2014, Methods in molecular biology.

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

Jill A. Livengood, S. Joshi, D. Volkin, 2017, Vaccine.

Development of stable liquid formulations for adenovirus-based vaccines.

R. K. Evans, J. Shiver, D. Volkin, 2004, Journal of pharmaceutical sciences.

Development of spirulina for the manufacture and oral delivery of protein therapeutics

Miaohua Zhang, Caitlin E. Gamble, R. Takeuchi, 2022, Nature Biotechnology.

The adsorption of proteins to pharmaceutical container surfaces

D. Volkin, M. Bruner, P. Tsai, 1992 .

The Storage and In-Use Stability of mRNA Vaccines and Therapeutics: Not A Cold Case

D. Volkin, D. Crommelin, E. Mastrobattista, 2022, Journal of Pharmaceutical Sciences.

SARS-CoV-2 receptor binding domain displayed on HBsAg virus–like particles elicits protective immunity in macaques

Neil C. Dalvie, J. C. Love, Sergio A. Rodriguez-Aponte, 2022, Science advances.

Current and next-generation formulation strategies for inactivated polio vaccines to lower costs, increase coverage, and facilitate polio eradication

S. Joshi, D. Volkin, Christopher Bird, 2022, Human vaccines & immunotherapeutics.

Compatibility, physical stability, and characterization of an IgG4 monoclonal antibody after dilution into different intravenous administration bags.

C Russell Middaugh, Sangeeta B Joshi, David B Volkin, 2012, Journal of pharmaceutical sciences.

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

S. Joshi, D. Volkin, R. Schwartz, 2016, Journal of pharmaceutical sciences.

Application of a high-throughput screening procedure with PEG-induced precipitation to compare relative protein solubility during formulation development with IgG1 monoclonal antibodies.

David B Volkin, J. Alvarez, D. Volkin, 2011, Journal of pharmaceutical sciences.

Evaluation of degradation pathways for plasmid DNA in pharmaceutical formulations via accelerated stability studies.

R. K. Evans, D. Volkin, M. Bruner, 2000, Journal of pharmaceutical sciences.

Alterations in the structure of proteins that cause their irreversible inactivation.

A. Klibanov, D. Volkin, 1992, Developments in biological standardization.

Protein comparability assessments and potential applicability of high throughput biophysical methods and data visualization tools to compare physical stability profiles

C. Russell Middaugh, Mohammad A. Alsenaidy, Nishant K. Jain, 2014, Front. Pharmacol..

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

S. Joshi, D. Volkin, R. Esfandiary, 2019, Journal of pharmaceutical sciences.

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

D. Volkin, C. Schöneich, Olivier Mozziconacci, 2016, Journal of pharmaceutical sciences.

Characterization of the photodegradation of a human IgG1 monoclonal antibody formulated as a high-concentration liquid dosage form.

Hui Zhao, Pei Qi, David B Volkin, 2009, Journal of pharmaceutical sciences.

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

Brittney J. Mills, S. Joshi, S. Bishop, 2017, Analytical chemistry.

Ongoing challenges to develop high concentration monoclonal antibody-based formulations for subcutaneous administration: Quo Vadis?

W. Jiskoot, D. Volkin, D. Crommelin, 2021, Journal of pharmaceutical sciences.

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

C Russell Middaugh, Sangeeta B Joshi, David B Volkin, 2017, Journal of pharmaceutical sciences.

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

C. Russell Middaugh, David B. Volkin, Steven M. Bishop, 2016, mAbs.

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

C Russell Middaugh, David B Volkin, D. Volkin, 2016, The journal of physical chemistry. B.

Hydrogen exchange mass spectrometry reveals protein interfaces and distant dynamic coupling effects during the reversible self-association of an IgG1 monoclonal antibody

S. Bishop, D. Volkin, R. Esfandiary, 2015, mAbs.

Protein instability and immunogenicity: roadblocks to clinical application of injectable protein delivery systems for sustained release.

Theodore W Randolph, C Russell Middaugh, Wim Jiskoot, 2012, Journal of pharmaceutical sciences.

Sucralfate and soluble sucrose octasulfate bind and stabilize acidic fibroblast growth factor.

D. Volkin, A. Verticelli, K. E. Marfia, 1993, Biochimica et biophysica acta.

Nature of the interaction of heparin with acidic fibroblast growth factor.

R. Linhardt, D. Volkin, L. Mattsson, 1993, Biochemistry.

Physical stabilization of acidic fibroblast growth factor by polyanions.

P K Tsai, R. Linhardt, D. Volkin, 1993, Archives of biochemistry and biophysics.

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

Eric J. Deeds, Peter A Kleindl, Maulik K. Nariya, 2017, Journal of pharmaceutical sciences.

Local dynamics and their alteration by excipients modulate the global conformational stability of an lgG1 monoclonal antibody.

Santosh V. Thakkar, S. Joshi, H. Sathish, 2012, Journal of pharmaceutical sciences.

Multi-dose Formulation Development for a Quadrivalent Human Papillomavirus Virus-Like Particle-Based Vaccine: Part II- Real-time and Accelerated Stability Studies.

S. Joshi, D. Volkin, S. Brendle, 2022, Journal of pharmaceutical sciences.

Interaction of aluminum-adjuvanted recombinant P[4] protein antigen with preservatives: Storage stability and backbone flexibility studies.

S. Joshi, D. Volkin, D. Weis, 2021, Journal of pharmaceutical sciences.

Short-term and longer-term protective immune responses generated by subunit vaccination with smallpox A33, B5, L1 or A27 proteins adjuvanted with aluminum hydroxide and CpG in mice challenged with vaccinia virus

S. Joshi, D. Volkin, G. Buchman, 2020, Vaccine.

Glassy-state stabilization of a dominant negative inhibitor anthrax vaccine containing aluminum hydroxide and glycopyranoside lipid A adjuvants.

Theodore W Randolph, C Russell Middaugh, Lilia A. Rabia, 2015, Journal of pharmaceutical sciences.

Preformulation characterization of an aluminum salt-adjuvanted trivalent recombinant protein-based vaccine candidate against Streptococcus pneumoniae.

C Russell Middaugh, Vidyashankara G. Iyer, Sangeeta B Joshi, 2012, Journal of pharmaceutical sciences.

Multidimensional methods for the formulation of biopharmaceuticals and vaccines.

S. Joshi, D. Volkin, J. Ralston, 2011, Journal of pharmaceutical sciences.

Effects of salts from the Hofmeister series on the conformational stability, aggregation propensity, and local flexibility of an IgG1 monoclonal antibody.

H. Sathish, S. Bishop, D. Volkin, 2013, Biochemistry.

Engineered SARS-CoV-2 receptor binding domain improves manufacturability in yeast and immunogenicity in mice

Laura E. Crowell, Neil C. Dalvie, J. C. Love, 2021, Proceedings of the National Academy of Sciences.

Engineered SARS-CoV-2 receptor binding domain improves immunogenicity in mice and elicits protective immunity in hamsters

Laura E. Crowell, Neil C. Dalvie, J. C. Love, 2021, bioRxiv.

Adsorption of recombinant poxvirus L1-protein to aluminum hydroxide/CpG vaccine adjuvants enhances immune responses and protection of mice from vaccinia virus challenge.

S. Joshi, D. Volkin, G. Buchman, 2013, Vaccine.

Comparison of high-throughput biophysical methods to identify stabilizing excipients for a model IgG2 monoclonal antibody: conformational stability and kinetic aggregation measurements.

C Russell Middaugh, Sangeeta B Joshi, David B Volkin, 2012, Journal of pharmaceutical sciences.

A C-terminal Pfs48/45 malaria transmission-blocking vaccine candidate produced in the baculovirus expression system

S. Joshi, D. Volkin, C. King, 2020, Scientific Reports.

The Pfs230 N-terminal fragment, Pfs230D1+: expression and characterization of a potential malaria transmission-blocking vaccine candidate

S. Joshi, D. Volkin, J. Hickey, 2019, Malaria Journal.

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

Ishan S. Shah, S. Joshi, D. Volkin, 2016, Journal of pharmaceutical sciences.

Formulation development of a live attenuated human rotavirus (RV3-BB) vaccine candidate for use in low- and middle-income countries

S. Joshi, D. Volkin, J. Bines, 2021, Human vaccines & immunotherapeutics.

Comparative Immunogenicity in Rhesus Monkeys of DNA Plasmid, Recombinant Vaccinia Virus, and Replication-Defective Adenovirus Vectors Expressing a Human Immunodeficiency Virus Type 1 gag Gene

R. K. Evans, T. Toner, J. Shiver, 2003, Journal of Virology.

Vaccine Delivery: Current Routes of Administration and Novel Approaches

Yuan Cheng, D. Volkin, N. Sahni, 2016 .

Characterization of an oncolytic herpes simplex virus drug candidate.

S. Joshi, D. Volkin, B. Kerwin, 2015, Journal of pharmaceutical sciences.

The Physical Analysis of Vaccines

S. Joshi, D. Volkin, Justin C. Thomas, 2015 .

High Throughput Screening for Stabilizers of Vaccine Antigens

S. Joshi, D. Volkin, C. Middaugh, 2013 .

Formulation design and high-throughput excipient selection based on structural integrity and conformational stability of dilute and highly concentrated IgG1 monoclonal antibody solutions.

C Russell Middaugh, Sangeeta B Joshi, David B Volkin, 2012, Journal of pharmaceutical sciences.

Biophysical characterization and stabilization of the recombinant albumin fusion protein sEphB4-HSA.

C Russell Middaugh, Sangeeta B Joshi, David B Volkin, 2012, Journal of pharmaceutical sciences.

Formulation, stability, and delivery of live attenuated vaccines for human use.

D. Volkin, T. Hsu, C. J. Burke, 1999, Critical reviews in therapeutic drug carrier systems.

Molecular engineering improves antigen quality and enables integrated manufacturing of a trivalent subunit vaccine candidate for rotavirus

Alexandra Bonnyman, John M. Hickey, David B. Volkin, 2020, bioRxiv.

Formulation Design of Acidic Fibroblast Growth Factor

C. Russell Middaugh, David B. Volkin, D. Volkin, 1993, Pharmaceutical Research.

Partially structured self-associating states of acidic fibroblast growth factor.

D. Volkin, H. Mach, C R Middaugh, 1993, Biochemistry.

Formulation and stabilization of recombinant protein based virus-like particle vaccines.

S. Joshi, D. Volkin, C. Russell Middaugh, 2015, Advanced drug delivery reviews.

An application of ultraviolet spectroscopy to study interactions in proteins solutions at high concentrations.

Santosh V. Thakkar, S. Joshi, D. Volkin, 2012, Journal of pharmaceutical sciences.

Measurement of Adenovirus-Based Vector Heterogeneity

Shaleem I Jacob, S. Joshi, D. Volkin, 2022, Journal of pharmaceutical sciences.

Effect of ionic strength and pH on the physical and chemical stability of a monoclonal antibody antigen-binding fragment.

C Russell Middaugh, Sangeeta B Joshi, David B Volkin, 2013, Journal of pharmaceutical sciences.

The Science is There: Key Considerations for Stabilizing Viral Vector-Based Covid-19 Vaccines

W. Jiskoot, A. Lubiniecki, D. Volkin, 2020, Journal of Pharmaceutical Sciences.

Vaccine-Induced Immunity in Baboons by Using DNA and Replication-Incompetent Adenovirus Type 5 Vectors Expressing a Human Immunodeficiency Virus Type 1 gag Gene

R. K. Evans, J. Shiver, E. Emini, 2003, Journal of Virology.

Identifying stabilizers of plasmid DNA for pharmaceutical use.

S. Joshi, D. Volkin, J. Ramsey, 2011, Journal of pharmaceutical sciences.

Modeling the long-term 2-8 °C stability profiles of a live, rotavirus vaccine candidate (RV3-BB) in various liquid formulations via extrapolations of real-time and accelerated stability data

S. Joshi, D. Volkin, J. Bines, 2021, Biologicals (Print).

Effect of Formulation Variables on the Stability of a Live, Rotavirus (RV3-BB) Vaccine Candidate using in vitro Gastric Digestion Models to Mimic Oral Delivery

S. Joshi, D. Volkin, J. Bines, 2020, Journal of pharmaceutical sciences.

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

S. Joshi, D. Volkin, R. Sitrin, 2020, Journal of pharmaceutical sciences.

Correlating physicochemical and biological properties to define critical quality attributes of a recombinant AAV vaccine candidate

S. Joshi, D. Volkin, L. Vandenberghe, 2023, bioRxiv.

Evaluation of a dual-wavelength size exclusion HPLC method with improved sensitivity to detect protein aggregates and its use to better characterize degradation pathways of an IgG1 monoclonal antibody.

H Zhao, D. Volkin, M. D. Bond, 2010, Journal of pharmaceutical sciences.

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

M. Klempner, L. Cavacini, S. Joshi, 2020, Journal of pharmaceutical sciences.

Developing a manufacturing process to deliver a cost effective and stable liquid human rotavirus vaccine

S. Joshi, D. Volkin, J. Bines, 2021, Vaccine.

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

S. Joshi, D. Volkin, R. Sitrin, 2019, Journal of pharmaceutical sciences.

Analytical lessons learned from selected therapeutic protein drug comparability studies.

David B Volkin, Anthony Lubiniecki, A. Lubiniecki, 2013, Biologicals : journal of the International Association of Biological Standardization.

Concordance of in vitro and in vivo measures of non-replicating rotavirus vaccine potency

S. Joshi, D. Volkin, R. Sitrin, 2022, Vaccine.

Crystallization of a nonreplicating rotavirus vaccine candidate

Moo Sun Hong, R. Braatz, K. Kaur, 2021, Biotechnology and Bioengineering.

Rapid Developability Assessments to Formulate Recombinant Protein Antigens as Stable, Low-Cost, Multi-Dose Vaccine Candidates: Case-Study With Non-Replicating Rotavirus (NRRV) Vaccine Antigens

Shaleem I Jacob, Neil C. Dalvie, J. C. Love, 2020, Journal of pharmaceutical sciences.

Mechanism of Thimerosal-Induced Structural Destabilization of a Recombinant Rotavirus P[4] Protein Antigen Formulated as a Multi-Dose Vaccine

Neil C. Dalvie, J. C. Love, Joseph R. Brady, 2020, Journal of pharmaceutical sciences.

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

S. Joshi, D. Volkin, J. Hickey, 2017, Vaccine.

Structural characterization of IgG1 mAb aggregates and particles generated under various stress conditions.

C Russell Middaugh, Sangeeta B Joshi, David B Volkin, 2014, Journal of pharmaceutical sciences.

Radar chart array analysis to visualize effects of formulation variables on IgG1 particle formation as measured by multiple analytical techniques.

C Russell Middaugh, David B Volkin, D. Volkin, 2013, Journal of pharmaceutical sciences.

Development of a stable virus-like particle vaccine formulation against Chikungunya virus and investigation of the effects of polyanions.

C Russell Middaugh, Sangeeta B Joshi, David B Volkin, 2013, Journal of pharmaceutical sciences.

Vaccines as physically and chemically well-defined pharmaceutical dosage forms

D. Volkin, C. Middaugh, 2010, Expert review of vaccines.

Safety, immunogenicity and efficacy in healthy infants of G1 and G2 human reassortant rotavirus vaccine in a new stabilizer/buffer liquid formulation

R. Ward, J. Bresee, E. Walter, 2003, The Pediatric infectious disease journal.

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

S. Joshi, D. Volkin, J. H. Kim, 2016, Journal of pharmaceutical sciences.

Physical stability comparisons of IgG1-Fc variants: effects of N-glycosylation site occupancy and Asp/Gln residues at site Asn 297.

S. Joshi, D. Volkin, J. H. Kim, 2014, Journal of pharmaceutical sciences.

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

S. Joshi, D. Volkin, D. Weis, 2017, Journal of pharmaceutical sciences.

Complement subcomponent C1q secreted by cultured human monocytes has subunit structure identical with that of serum C1q.

D. Volkin, A. Tenner, 1986, The Biochemical journal.

Measurement of Adenovirus-Based Vector Heterogeneity

Shaleem I Jacob, S. Joshi, D. Volkin, 2022, Journal of pharmaceutical sciences.

Size and conformational stability of the hepatitis A virus used to prepare VAQTA, a highly purified inactivated vaccine.

D. Volkin, K. E. Marfia, C. B. Oswald, 1997, Journal of pharmaceutical sciences.

A ferritin-based COVID-19 nanoparticle vaccine that elicits robust, durable, broad-spectrum neutralizing antisera in non-human primates

B. Pulendran, M. Feinberg, S. Joshi, 2022, bioRxiv.

Formulation development and comparability studies with an aluminum-salt adjuvanted SARS-CoV-2 spike ferritin nanoparticle vaccine antigen produced from two different cell lines

S. Joshi, D. Volkin, Ozan S. Kumru, 2023, bioRxiv.

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

John P. Moore, A. Ward, A. Cupo, 2019, Journal of pharmaceutical sciences.

Characterization and stabilization of recombinant human protein pentraxin (rhPTX-2).

C Russell Middaugh, Sangeeta B Joshi, David B Volkin, 2013, Journal of pharmaceutical sciences.

Probing structurally altered and aggregated states of therapeutically relevant proteins using GroEL coupled to bio‐layer interferometry

S. Joshi, D. Volkin, Ozan S. Kumru, 2014, Protein science : a publication of the Protein Society.

Comparison of the structural stability and dynamic properties of recombinant anthrax protective antigen and its 2-fluorohistidine-labeled analogue.

Santosh V. Thakkar, S. Joshi, D. Volkin, 2012, Journal of pharmaceutical sciences.

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

A. Metters, S. Joshi, D. Volkin, 2017, Journal of pharmaceutical sciences.

Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size

S. Joshi, D. Volkin, Ozan S. Kumru, 2013 .

Thermal destruction processes in proteins involving cystine residues.

A. Klibanov, D. Volkin, 1987, The Journal of biological chemistry.

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

D. Volkin, M. Treuheit, Feng He, 2018, Biochemistry.

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

D. Volkin, P. Thapa, Newton Wahome, 2016, Methods in molecular biology.

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

S. Joshi, D. Volkin, R. Schwartz, 2018, Journal of pharmaceutical sciences.

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

K. Früh, S. Joshi, D. Volkin, 2019, Vaccine.

Formulation and stabilization of a recombinant human Cytomegalovirus vector for use as a candidate vaccine for HIV-1

S. Joshi, D. Volkin, Ozan S. Kumru, 2018 .

Two decades of publishing excellence in pharmaceutical biotechnology.

G. Winter, D. Volkin, S. Uchiyama, 2015, Journal of pharmaceutical sciences.

High-Throughput Biophysical Analysis of Protein Therapeutics to Examine Interrelationships Between Aggregate Formation and Conformational Stability

D. Volkin, Rajoshi Chaudhuri, C. Middaugh, 2013, The AAPS Journal.

Impact of polysorbate 80 grade on the interfacial properties and interfacial stress induced subvisible particle formation in monoclonal antibodies.

Maria O. Ogunyankin, D. Bindra, M. Gokhale, 2020, Journal of pharmaceutical sciences.

Comparison of Protein Particle Formation in IgG1 mAbs Formulated with PS20 Vs. PS80 When Subjected to Interfacial Dilatational Stress

Maria O. Ogunyankin, M. Gokhale, D. Volkin, 2023, AAPS PharmSciTech.

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

David B Volkin, Prajnaparamita Dhar, D. Volkin, 2016, Journal of pharmaceutical sciences.

Developability assessments of monoclonal antibody candidates to minimize aggregation during large-scale ultrafiltration and diafiltration (UF-DF) processing.

S. Joshi, D. Volkin, P. Dhar, 2022, Journal of pharmaceutical sciences.

Evaluating the combined impact of temperature and application of interfacial dilatational stresses on surface-mediated protein particle formation in monoclonal antibody formulations.

D. Volkin, P. Dhar, Neal Whitaker, 2021, Journal of pharmaceutical sciences.

Calculating the mass of subvisible protein particles with improved accuracy using microflow imaging data.

D. Volkin, Ozan S. Kumru, Cavan K Kalonia, 2015, Journal of pharmaceutical sciences.

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

Eric J. Deeds, Peter A Kleindl, Maulik K. Nariya, 2017, Journal of pharmaceutical sciences.

Multi-dose Formulation Development for a Quadrivalent Human Papillomavirus Virus-Like Particle-Based Vaccine: Part I- Screening of Preservative Combinations.

S. Joshi, D. Volkin, S. Brendle, 2022, Journal of pharmaceutical sciences.

Preformulation studies as an essential guide to formulation development and manufacture of protein pharmaceuticals.

C Russell Middaugh, David B Volkin, D. Volkin, 2002, Pharmaceutical biotechnology.

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

D. Volkin, J. Hickey, Newton Wahome, 2016, Methods in molecular biology.

Mechanism of a decrease in potency for the recombinant influenza A virus hemagglutinin H3 antigen during storage.

B. Buckland, S. Joshi, D. Volkin, 2014, Journal of pharmaceutical sciences.

Formulation Studies to Develop Low-cost, Orally-delivered Secretory IgA Monoclonal Antibodies for Passive Immunization Against Enterotoxigenic Escherichia coli.

M. Klempner, L. Cavacini, S. Joshi, 2023, Journal of pharmaceutical sciences.

Minimizing Carry-Over in an Online Pepsin Digestion System used for the H/D Exchange Mass Spectrometric Analysis of an IgG1 Monoclonal Antibody

D. Volkin, J. Hickey, D. Weis, 2012, Journal of The American Society for Mass Spectrometry.

The Biomedical Engineering Handboo

Joo L. Ong, David J. Mooney, Mehmet Toner, 2007 .

Development of a high-throughput RT-PCR based viral infectivity assay for monitoring the stability of a replicating recombinant Lymphocytic Choriomeningitis viral vector

S. Joshi, D. Volkin, G. Fuhrmann, 2021, Journal of Virological Methods.

Correlations between changes in conformational dynamics and physical stability in a mutant IgG1 mAb engineered for extended serum half-life

S. Bishop, D. Volkin, R. Esfandiary, 2015, mAbs.

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

M. Rudolph, D. Volkin, N. Mantis, 2018, Antibodies.

Improved data visualization techniques for analyzing macromolecule structural changes

C Russell Middaugh, Vidyashankara G. Iyer, Sangeeta B Joshi, 2012, Protein science : a publication of the Protein Society.

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

D. Volkin, N. Mantis, D. Weis, 2018, ImmunoHorizons.

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

D. Volkin, C. Russell Middaugh, N. Mantis, 2018, bioRxiv.

A ferritin-based COVID-19 nanoparticle vaccine that elicits robust, durable, broad-spectrum neutralizing antisera in non-human primates

B. Pulendran, M. Feinberg, S. Joshi, 2023, Nature communications.

Nanoalum Formulations Containing Aluminum Hydroxide and CpG 1018TM Adjuvants: The Effect on Stability and Immunogenicity of a Recombinant SARS-CoV-2 RBD Antigen

J. C. Love, Sergio A. Rodriguez-Aponte, S. Joshi, 2023, Vaccines.

Preformulation studies--The next advance in aluminum adjuvant-containing vaccines.

D. Volkin, S. Hem, C. Middaugh, 2010, Vaccine.

Analysis of vaccine stability.

G. Sanyal, D. Volkin, Gautam Sanyal, 1996, Developments in biological standardization.

Correlating excipient effects on conformational and storage stability of an IgG1 monoclonal antibody with local dynamics as measured by hydrogen/deuterium-exchange mass spectrometry.

C Russell Middaugh, John M Hickey, David D Weis, 2013, Journal of pharmaceutical sciences.

Correlating physicochemical and biological properties to define critical quality attributes of a rAAV vaccine candidate

S. Joshi, D. Volkin, L. Vandenberghe, 2023, Molecular Therapy - Methods & Clinical Development.

Formulation Development and Improved Stability of a Combination Measles and Rubella Live-Viral Vaccine Dried for Use in the NanopatchTM Microneedle Delivery System

S. Joshi, D. Volkin, Paul V Fahey, 2021, Human vaccines & immunotherapeutics.

The characterization, stabilization, and formulation of acidic fibroblast growth factor.

D. Volkin, C R Middaugh, D B Volkin, 1996, Pharmaceutical biotechnology.

Characterization of the physical stability of a lyophilized IgG1 mAb after accelerated shipping-like stress.

Srivalli Telikepalli, C Russell Middaugh, Sangeeta B Joshi, 2015, Journal of pharmaceutical sciences.

Effects of aluminum-salt, CpG and emulsion adjuvants on the stability and immunogenicity of a virus-like particle displaying the SARS-CoV-2 receptor-binding domain (RBD)

K. Kaur, S. Joshi, D. Volkin, 2023, bioRxiv.

A C-terminal Pfs48/45 malaria transmission-blocking vaccine candidate produced in the baculovirus expression system

S. Joshi, D. Volkin, C. King, 2020, Scientific Reports.

Applications of Ultraviolet Absorption Spectroscopy to the Analysis of Biopharmaceuticals

D. Volkin, H. Mach, Gautam Sanyal, 1997 .

Characterization and biological evaluation of a microparticle adjuvant formulation for plasmid DNA vaccines.

R. K. Evans, J. Shiver, D. Volkin, 2004, Journal of pharmaceutical sciences.

Bacteriophage T7 RNA polymerase and its active-site mutants. Kinetic, spectroscopic and calorimetric characterization.

A. Woody, N. Sreerama, R. Woody, 1994, Journal of molecular biology.

Preformulation studies--The next advance in aluminum adjuvant-containing vaccines.

D. Volkin, S. Hem, C. Middaugh, 2010, Vaccine.

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

J. Karanicolas, D. Volkin, N. Mantis, 2017, Proteins.

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

S. Joshi, D. Volkin, J. Hickey, 2017, Journal of pharmaceutical sciences.

An improved methodology for multidimensional high-throughput preformulation characterization of protein conformational stability.

Nathaniel R Maddux, C Russell Middaugh, David B Volkin, 2012, Journal of pharmaceutical sciences.

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

S. Joshi, S. Bishop, D. Volkin, 2018, Journal of pharmaceutical sciences.

Studies of the aggregation of RNase Sa.

S. Joshi, D. Volkin, R. Kramer, 2014, Journal of pharmaceutical sciences.

A Combined LC-MS and Immunoassay Approach to Characterize Preservative-Induced Destabilization of Human Papillomavirus Virus-like Particles Adsorbed to an Aluminum-Salt Adjuvant

D. Volkin, U. Shaligram, Vikas Dogar, 2024, Vaccines.

Correlating physicochemical and biological properties to define critical quality attributes of a rAAV vaccine candidate

S. Joshi, D. Volkin, L. Vandenberghe, 2023, Molecular Therapy - Methods & Clinical Development.

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

Maulik K. Nariya, S. Joshi, D. Volkin, 2017, Journal of pharmaceutical sciences.

An application of ultraviolet spectroscopy to study interactions in proteins solutions at high concentrations.

Santosh V. Thakkar, S. Joshi, D. Volkin, 2012, Journal of pharmaceutical sciences.

MIT Open Access Articles Nanoalum Formulations Containing Aluminum Hydroxide and CpG 1018TM Adjuvants: The Effect on Stability and Immunogenicity of a Recombinant SARS-CoV-2 RBD Antigen

Sergio A. Rodriguez-Aponte, S. Joshi, D. Volkin, 2022 .

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

S. Joshi, D. Volkin, L. Kueltzo, 2016, Journal of pharmaceutical sciences.

Investigation of a monoclonal antibody against enterotoxigenic 1 Escherichia coli , expressed as secretory IgA1 and IgA2 in plants. 2

L. Cavacini, S. Joshi, D. Volkin, 2020 .