Publications

PubMed Articles for VAFC PI/Co-PI:

DB Volkin | SB Joshi

Selected Recent Publications from the VAFC:

• Whitaker N, Pace S, Merritt K, Tadros M, Khossravi M, Deshmukh S, Cheng Y, Joshi SB, Volkin DB, Dhar P “Developability assessments of monoclonal antibody candidates to minimize aggregation during large-scale ultrafiltration and diafiltration (UF-DF) processing” J. Pharm Sci. In Press (2022)
• Jerajani K, Wan Y, Hickey JM, Kumru OS, Sharma N, Pullagurla SR, Ogun O, Mapari S, Whitaker N, Brendle S, Christensen ND, Batwal S, Mahedvi M, Rao H, Dogar V, Chandrasekharan R, Shaligram U, Joshi SB, Volkin DB “Analytical and preformulation characterization studies of human papillomavirus virus-like particles to enable quadrivalent multi- dose vaccine formulation development” J. Pharm Sci. In Press (2022)​
• McAdams D, Estrada M, Holland D, Singh J, Sawant N, Hickey JM, Kumar P, Plikaytis B, Joshi SB, Volkin DB, Sitrin R, Cryz S, White JA. "Concordance of in vitro and in vivo measures of non-replicating rotavirus vaccine potency" Vaccine 40(4):5069-5078 (2022)
• Bajoria S., Kaur K., Kumru, OS., Van Slyke G., Doering J., Novak H., Rodriguez-Aponte SA., Dalvie NC., Naranjo CA., Johnston RS. and Maxwell Silverman J., Kleanthous H., Love JC., Mantis NJ, Joshi SB, Volkin DB. "Antigen-adjuvant interactions, stability, and immunogenicity profiles of a SARS-CoV-2 receptor-binding domain (RBD) antigen formulated with aluminum salt and CpG adjuvants" Hum Vaccin Immunother Published online June 6 (2022)
• Jester BW, Zhao H, Gewe M, Adame T, Perruzza L, Bolick DT, Agosti J, Khuong N, Kuestner R, Gamble C, Cruickshank K, Ferrara J, Lim R, Paddock T, Brady C, Ertel S, Zhang M, Pollock A, Lee J, Xiong J, Tasch M, Saveria T, Doughty D, Marshall J, Carrieri D, Goetsch L, Dang J, Sanjaya N, Fletcher D, Martinez A, Kaldis B, Sigmar K, Afreen E, Nguyen T, Randolph A, Taber A, Krzeszowski A, Robinett B, Volkin DB, Grassi F, Guerrant R, Takeuchi R, Finrow B, Behnke C, Roberts J. “Development of spirulina for the manufacture and oral delivery of protein therapeutics” Nat. Biotechnol 40(6):956-964 (2022)
• Griffin VP, Merrit K, Vaclaw C, Whitaker N, Volkin DB, Ogunyankin MO, Pace S, Dhar P,. “Evaluating the combined impact of temperature and application of interfacial dilatational stresses on surface-mediated protein particle formation in monoclonal antibody formulations” J. Pharm Sci 3(3): 680-689 (2022)
• Pullagurla SR, Kumar P, Ogun O, Kumru OS, Hamidi A, Hoeksema F, Yallop C, Bines JE, Volkin DB, Joshi SB. “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.” Biologicals 75:21-28 (2022)
• Gupta V, Antunez LR, Saleh-Birdjandi S, Kumru OS, Pospisil R, Lilja A, Fuhrmann G, Smith L, Volkin DB, Joshi SB. “Development of a high-throughput RT-PCR based viral infectivity assay for monitoring the stability of a replicating recombinant Lymphocytic Choriomeningitis viral vector” J. Virol Methods J Virol Methods 301:114449 (2022)
• Jiskoot W, Hawe A, Menzen T, Volkin DB, Crommelin DJA. "Ongoing challenges to develop high concentration monoclonal antibody-based formulations for subcutaneous administration: quo vadis?" J Pharm Sci 111(4):861-867 (2022)
• Sawant, N, Joshi SB, Weis, David D, Volkin, David B. “Interaction of aluminum-adjuvanted recombinant P[ 4] protein antigen with preservatives: storage stability and backbone flexibility studies” J. Pharm Sci. 110(3):1042-1053 (2021)
• Dalvie NC, Rodriguez-Aponte SA, Hartwell BL, Tostanoski LH, Biedermann AM, Crowell LE, Kaur K, Kumru OS, Carter L, Yu J, Chang A, McMahan K, Courant T, Lebas C, Lemnios AA, Rodrigues KA, Silva M, Johnston RS, Naranjo CA, Tracey MK, Brady JR, Whittaker CA, Yun D, Brunette N, Wang JY, Walkey C, Fiala B, Kar S, Porto M, Lok M, Andersen H, Lewis MG, Love KR, Camp DL, Silverman JM, Kleanthous H, Joshi SB, Volkin DB, Dubois PM, Collin N, King NP, Barouch DH, Irvine DJ, Love JC "Engineered SARS-CoV-2 receptor binding domain improves manufacturability in yeast and immunogenicity in mice" Proc Natl Acad Sci 118(38): e2106845118 (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)
• 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 6:1-16  (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 39(15):2048-2059 (2021)
• Dalvie NC, Brady JR, Crowell LE, Tracey MK, Biedermann AM, Kaur K, Hickey JM, Kristensen DL 2nd, Bonnyman AD, Rodriguez-Aponte SA, Whittaker CA, Bok M, Vega C, Mukhopadhyay TK, Joshi SB, Volkin DB, Parreño V, Love KR, Love JC “Molecular engineering improves antigen quality and enables integrated manufacturing of a trivalent subunit vaccine candidate for rotavirus” Microb Cell Fact. 1;20(1):94  (2021)
• Dalvie NC, Rodriguez-Aponte SA, Hartwell BL, Tostanoski LH, Biedermann AM, Crowell LE, Kaur K, Kumru O, Carter L, Yu J, Chang A, McMahan K, Courant T, Lebas C, Lemnios AA, Rodrigues KA, Silva M, Johnston RS, Naranjo CA, Tracey MK, Brady JR, Whittaker CA, Yun D, Kar S, Porto M, Lok M, Andersen H, Lewis MG, Love KR, Camp DL, Silverman JM, Kleanthous H, Joshi SB, Volkin DB, Dubois PM, Collin N, King NP, Barouch DH, Irvine DJ, Love JC “ Engineered SARS-CoV-2 receptor binding domain improves immunogenicity in mice and elicits protective immunity in hamsters” Natl Acad Sci U S A. 2021 Sep 21;118(38):e2106845118. doi: 10.1073/pnas.2106845118. (2021)
• Hong MS, Kaur K, Sawant N, Joshi SB, Volkin DB, Braatz RD “Crystallization of a nonreplicating rotavirus vaccine candidate” Biotechnol Bioeng 13(1):1-14 (2021)
• Dalvie NC, Tostanoski LH, Rodriguez-Aponte SA, Kaur K, Bajoria S, Kumru OS, Martinot AJ, Chandrashekar A, McMahan K, Mercado NB, Yu J, Chang A, Giffin VM, Nampanya F, Patel S, Bowman L, Naranjo CA, Yun D, Flinchbaugh Z, Pessaint L, Brown R, Velasco J, Teow E, Cook A, Andersen H, Lewis MG, Camp DL, Silverman JM, Kleanthous H, Joshi SB, Volkin DB, Biswas S, Love JC, Barouch DH. “A modular protein subunit vaccine candidate produced in yeast confers protection against SARS-CoV-2 in non-human primates” bioRxiv (2021)
• 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)
• 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 17(7):2298-2310 (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)
• 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)
• 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)
• 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)