Publications

PubMed Articles for VAFC PI/Co-PI:

DB Volkin | SB Joshi

Selected Recent Publications from the VAFC:

• Kumar P, Pullagurla SR, Patel A, Shukla RS, Bird C, Kumru OS, Hamidi A, Hoeksema F, Yallop C, Bines JE, Joshi SB, Volkin DB.  “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” J Pharm Sci 110(2):760-770 (2021)
• Hong MS, Kaur K, Sawant N, Joshi SB, Volkin DB, Braatz RD. "Crystillization of a nonreplicating rotavirus vaccine candidate" Biotechnol Bioeng 118(4):1750-1756 (2021)
• Hamidi A, Hoeksema F, Velthof P, Lemckert A, Gillissen G, Luitjens A, Bines JE, Pullagurla SR, Kumar P, Volkin DB, Joshi SB, Havenga M, Bakker WAM, Yallop C. "Developing a manufacturing process to deliver a cost effective and stable liquid human rotavirus vaccine" Vaccine In Press (2021)
• Sawant N, Kaur K, Holland D, Hickey JM, Agarwal S, Brady J, Dalvie N, Tracey M, Velez-Suberbie L, Morris S, Shaleem J, Bracewell D, Mukhopadhyay T. Love K, Love J, Joshi SB, Volkin DB “ 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” J. Pharm Sci. 110(3):1042-1053 (2021)
• Kaur K, Holland D, Sawant N, Agarwal S, Hickey J, Holland D, Mukhopadhyay T, Brady J, Dalvie N, Tracey M, Love K, Love J, , Joshi SB, Volkin DB “Mechanism of thimerosal-induced structural destabilization of a recombinant rotavirus P[4] protein antigen for a multi-dose vaccine” J. Pharm Sci 110(3):1054-1066 (2021)
• Teh AY, Cavacini L, Hu Y, Kumru OS, Xiong J, Bolick DT, Joshi SB, Grünwald-Gruber C, Altmann F, Klempner M, Guerrant RL, Volkin DB, Wang Y, Ma JK “Investigation of a monoclonal antibody against enterotoxigenic Escherichia coli, expressed as secretory IgA1 and IgA2 in plants” Gut Microbes 13(1):1-14 (2021)
• Kumar P, Shukla R, Patel A, Pullagurla S, Bird C, Ogun O, Kumru OS, Hamidi A, Hoeksema F, Yallop C, Bines JE, Joshi SB, Volkin DB. “Formulation Development of a Live Attenuated Human Rotavirus (RV3-BB) Vaccine Candidate for use in Low and Middle-Income Countries” Human Vaccines and Immunotherapeutics (In Press 2021)
• Wan Y, Gupta V, Bird C, Pullagurla S, Fahey P, Forster A, Volkin DB, Joshi SB. “Formulation Development and Improved Stability of a Combination Measles and Rubella Live-Viral Vaccine Dried for use in the NanopatchTM Microneedle Delivery System ” Human Vaccines and Immuotherapeutics (In Press 2021)
• Vaclaw C, Merritt K, Pringle V, Whitaker N, Gokhale M, Carvalho T, Pan D, Liu Z, Bindra D, Khossravi M, Bolgar M, Volkin DB, Ogunyankin MO, Dhar P. “Impact of polysorbate 80 grade on the interfacial properties and interfacial stress induced subvisible particle formation in monoclonal antibodies” J Pharm Sci.110(2):746-759 (2020)
• Lee SM, Hickey JM, Miura K, Joshi SB, Volkin DB, King CR, Plieskatt JL “A C-terminal Pfs48/45 malaria transmission-blocking vaccine candidate produced in the baculovirus expression system.” Sci Rep. 10(1):395 (2020)
• Perruzza L, Jaconi S, Lombardo G, Pinna D, Strati F, Morone D, Seehusen F, Hu Y, Bajoria S, Xiong J, Kumru OS, Joshi SB, Volkin DB, Piantanida R, Benigni F, Grassi F, Corti D, Pizzuto MS “Prophylactic Activity of Orally Administered FliD-Reactive Monoclonal SIgA Against Campylobacter Infection” Front. Immunol. 11:1011 (2020)
• Vaclaw C, Merritt K, Pringle V, Whitaker N, Gokhale M, Carvalho T, Pan D, Liu Z, Bindra D, Khossravi M, Bolgar M, Volkin DB, Ogunyankin MO, Dhar P. “Impact of polysorbate 80 grade on the interfacial properties and interfacial stress induced subvisible particle formation in monoclonal antibodies” J Pham Sci. In Press (2020)
• Xiao Y, Zeng Y, Schante C, Joshi SB, Buchman GW, Volkin DB, Middaugh CR, Isaacs SN. “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” Vaccine Epub 2020 Jul 30 (2020)
• Crommelin DJA, Volkin DB, Hoogendoorn KH, Lubiniecki AS, Jiskoot W. “The science is there: key considerations for stabilizing viral vector-based Covid-19 vaccines” J. Pharm Sci. 110(2):627-34 (2020)
• Crommelin DJA, Anchordoquy TJ, Volkin DB, Jiskoot W, Mastrobattista E. “Addressing the cold reality of mRNA vaccine stability” J. Pharm Sci. 110(3):997-1001 (2020)
• Kumar P, Pullagurla SR, Patel A, Shukla RS, Bird C, Kumru OS, Hamidi A, Hoeksema F, Yallop C, Bines JE, Joshi SB, Volkin DB.  “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 J. Pharm Sci. In Press (2020)
• Sawant N, Kaur K, Holland D, Hickey JM, Agarwal S, Brady J, Dalvie N, Tracey M, Velez-Suberbie L, Morris S, Shaleem J, Bracewell D, Mukhopadhyay T. Love K, Love J, Joshi SB, Volkin DB “ 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” J. Pharm Sci. In Press (2020)
• Kaur K, Holland D, Sawant N, Agarwal S, Hickey J, Holland D, Mukhopadhyay T, Brady J, Dalvie N, Tracey M, Love K, Love J, , Joshi SB, Volkin DB “Mechanism of thimerosal-induced structural destabilization of a recombinant rotavirus P[4] protein antigen for a multi-dose vaccine” J. Pharm Sci. In Press (2020)
• Lee SM, Hickey JM, Miura K, Joshi SB, Volkin DB, King CR, Plieskatt JL “A C-terminal Pfs48/45 malaria transmission-blocking vaccine candidate produced in the baculovirus expression system.” Sci Rep. 10(1):395 (2020)
• Perruzza L, Jaconi S, Lombardo G, Pinna D, Strati F, Morone D, Seehusen F, Hu Y, Bajoria S, Xiong J, Kumru OS, Joshi SB, Volkin DB, Piantanida R, Benigni F, Grassi F, Corti D, Pizzuto MS “Prophylactic Activity of Orally Administered FliD-Reactive Monoclonal SIgA Against Campylobacter Infection” Front. Immunol. 11:1011 (2020)
• Xiao Y, Zeng Y, Schante C, Joshi SB, Buchman GW, Volkin DB, Middaugh CR, Isaacs SN. “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” Vaccine Epub 2020 Jul 30 (2020)
• Crommelin DJA, Volkin DB, Hoogendoorn KH, Lubiniecki AS, Jiskoot W. “The science is there: key considerations for stabilizing viral vector-based Covid-19 vaccines” J. Pharm Sci. In Press (2020)
• Kumar P, Pullagurla SR, Patel A, Shukla RS, Bird C, Kumru OS, Hamidi A, Hoeksema F, Yallop C, Bines JE, Joshi SB, Volkin DB.  “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 J. Pharm Sci. In Press (2020)
• Sawant N, Kaur K, Holland D, Hickey JM, Agarwal S, Brady J, Dalvie N, Tracey M, Velez-Suberbie L, Morris S, Shaleem J, Bracewell D, Mukhopadhyay T. Love K, Love J, Joshi SB, Volkin DB “ 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” J. Pharm Sci. In Press (2020)
• Kaur K, Holland D, Sawant N, Agarwal S, Hickey J, Holland D, Mukhopadhyay T, Brady J, Dalvie N, Tracey M, Love K, Love J, , Joshi SB, Volkin DB “Mechanism of thimerosal-induced structural destabilization of a recombinant rotavirus P[4] protein antigen for a multi-dose vaccine” J. Pharm Sci. In Press (2020)
• Velez-Suberbie ML, Morris SA, Kaur K, Hickey JM, Joshi SB, Volkin DB, Bracewell DG, Mukhopadhyay TK “Holistic process development to mitigate proteolysis of a subunit rotavirus vaccine candidate produced in Pichia pastoris by means of an acid pH pulse during fed-batch fermentation.” Biotechnol Prog 36(3):e2966 (2020)
• Agarwal S, Hickey JM, Sahni N, Toth RT 4th, Robertson GA, Sitrin R, Cryz S, Joshi SB, Volkin DB. “Recombinant subunit rotavirus trivalent vaccine candidate: Physicochemical comparisons and stability evaluations of three protein antigens” J. Pharm Sci. 109(1):380-393 (2020)
• Hu Y, Kumru OS, Xiong J, Antunez LR, Hickey J, Wang Y, Cavacini L, Klempner M, Joshi SB, Volkin DB. “Preformulation characterization and stability assessments of secretory IgA monoclonal antibodies as potential candidates for passive immunization by oral administration” J. Pharm Sci. 109(1):407-421 (2020)
• Agarwal S, Sahni N, Hickey JM, Robertson GA, Sitrin R, Cryz S, Joshi SB, Volkin DB “Characterizing and minimizing aggregation and particle formation of three recombinant fusion-protein bulk antigens for use in a candidate trivalent rotavirus vaccine” J. Pharm Sci. 109(1):394-406 (2020)
• Agarwal S, Hickey JM, McAdams D, White JA, Sitrin R, Khandke L, Cryz S, Joshi SB, Volkin DB "Effect of aluminum adjuvant and preservatives on structural integrity and physicochemical stability profiles of three recombinant subunit rotavirus vaccine antigens" J Pharm Sci 109(1):476-487 (2020)
• Perruzza L, Jaconi S, Lombardo G, Pinna D, Strati F, Morone D, Seehusen F, Hu Y, Bajoria S, Xiong J, Kumru OS, Joshi SB, Volkin DB, Piantanida R, Benigni F, Grassi F, Corti D, Pizzuto MS “Prophylactic Activity of Orally Administered FliD-Reactive Monoclonal SIgA Against Campylobacter Infection” Front. Immunol. 11:1011 (2020)
• Lee SM, Hickey JM, Miura K, Joshi SB, Volkin DB, King CR, Plieskatt JL “A C-terminal Pfs48/45 malaria transmission-blocking vaccine candidate produced in the baculovirus expression system.” Sci Rep. 10(1):395 (2020)
• Hu Y, Arora J, Joshi SB, Esfandiary R, Middaugh CR, Weis DD, Volkin DB. “Characterization of excipient effects on reversible self-association, backbone flexibility, and solution properties of an IgG1 monoclonal antibody at high concentrations: Part 2.” J. Pharm Sci. 109(1):353-363 (2020)
• Hu Y, Arora J, Joshi SB, Esfandiary R, Middaugh CR, Weis DD, Volkin DB. “Characterization of excipient effects on reversible self-association, backbone flexibility, and solution properties of an IgG1 monoclonal antibody at high concentrations: Part 1.” J. Pharm Sci. 109(1):340-352 (2020)
• 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. "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. J. Pharm.Sci. 108(7):2264-2277 (2019)
• 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 "Stabilization and formulation of a recombinant Human Cytomegalovirus vector for use as a candidate HIV-1 vaccine" Vaccine 37(44): 6696-6706 (2019)
• 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 NanopatchTM Microprojection Array” J Pharm Sci. 107(6):1540-1551 (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)
• 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 Staphylococcus aureus Alpha-toxin” J. Pharm Sci. 107(9): 2325-2334 (2018)
• 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.107(7): 1806-1819 (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.107(11): 2764-2774 (2018)
• 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-ike particle vaccine candidate” J. Pharm Sci. 107(10): 2544-2558 (2018)
• Patel A, Gupta V, Hickey J, Nightlinger NS, Rogers RS, Siska C, Joshi SB, Seaman MS, Volkin DB, Kerwin BA. Co-formulation of broadly neutralizing antibodies 3BNC117 and PGT121: Analytical challenges during pre-formulation characterization and storage stability studies. J. Pharm Sci. 107(12):3032-3046 (2018)
• 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)
• 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 35 (41): 5471-5480 (2017)