Recombinant Protein Vaccines

Kumru OS, Bajoria S, Kaur K, Hickey JM, Van Slyke G, Doering J, Berman K, Richardson C, Lien H, Kleanthous H, Mantis NJ, Joshi SB, Volkin DB. “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)” Hum VaccinImmunother 19(2):2264594 (2023)

Kumru OS, Sanyal M, Friedland N, Hickey J, Joshi R, Weidenbacher P, Do J, Cheng YC, Kim PS, Joshi SB, Volkin DB. "Formulation development and comparability studies with an aluminum-salt adjuvanted SARS-CoV-2 spike ferritin nanoparticle vaccine antigen produced from two different cell lines" Vaccine 41: 6502-6513 (2023)

Bajoria S, Kumru OS, Doering J, Berman K, Slyke GV, Prigodich A, Rodriguez-Aponte SA, Kleanthous H, Love JC, Mantis NJ, Joshi SB and Volkin DB. “Nanoalum Formulations Containing Aluminum Hydroxide and Cpg 1018 TM Adjuvants: The Effect on Stability and Immunogen-Icity of a Recombinant SARS-CoV-2 Rbd Antigen” Vaccines 11(6)1030 (2023)

Kumar P, Wang M, Kumru OS, Hickey JM, Sanmiguel J, Zabaleta N, Vandenberghe LH, Joshi SB, Volkin DB. "Correlating physicochemical and biological

properties to define critical quality attributes of a rAAV vaccine candidate" Molecular Therapy-Methods & Clinical Development 30: 103-121 (2023)

Weidenbacher PA, Sanyal M, Friedland N, Tang S, Arunachalam PS, Hu M, Kumru OS, Morris MK, Fontenot J, Shirreff L, Do J, Cheng YC, Vasudevan G, Feinberg MB, Villinger FJ, Hanson C, Joshi SB, Volkin DB, Pulendran B, Kim PS. “A ferritin-based COVID-19 nanoparticle vaccine that elicits robust, durable, broad-spectrum neutralizing antisera in non-human primates” Nature 14: 2149 (2023)

Rodriguez-Aponte SA, Naranjo CA, Johnston RS, Dalvie NC, Crowell LE, Bajoria S, Kumru OS, Joshi SB, Volkin DB, Love JC. “Minimal purification method enables developability assessment of recombinant proteins”Biotechnol Bioeng 41(5):1108-1118 (2023)

Sharma N, Jerajani K, Wan Y, Kumru OS, Pullagurla SP, Ogun O, Mapari S, Brendle S, Christensen ND, Batwal S, Mahedvi M, Rao H, Dogar V, Chandrasekharan R, Shaligram U, Joshi SB, Volkin DB “Multi-Dose Formulation Development for a Quadrivalent Human Papillomavirus Virus-Like Particle-Based Vaccine: Part II - Real-time and accelerated stability studies” J.Pharm Sci 112(2):458-470 (2023)

Jerajani K, Wan Y, Kumru OS, Pullagurla SP, Kumar P, Sharma N, Ogun O, Mapari S, Brendle S, Christensen ND, Batwal S, Mahedvi M, Rao H, Dogar V, Chandrasekharan R, Shaligram U, Joshi SB, Volkin DB “Multi-Dose Formulation Development for a Quadrivalent Human Papillomavirus Virus-Like Particle-Based Vaccine: Part I - Screening of Preservative Combinations” J.Pharm Sci 112(2):446-457 (2023)

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. 111(11):2983-2997 (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  VOL. 18, NO. 5 Published online June 6 (2022)

Sawant N, Joshi SB, Weis DD, Volkin DB. “Interaction of aluminum-adjuvanted recombinant p[4] protein antigen with preservatives: storage stability and backbone flexibility studies” J. Pharm Sci 111(4):970-981 (2022)

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)

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)

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)

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)

Whitaker N, Hickey JM, Kaur K, Xiong J, Sawant N, Cupo A, Wen-Hsin L, Ozorowski G, Medina-Ramirez M, Ward AB, Sanders RW, More 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)

Lee SM, Wu Y, Hickey JM, Miura K, Whitaker N, Joshi SB, Volkin DB, Richter King C, Plieskatt J.,“The Pfs230 N-terminal fragment, Pfs230D1+: expression and characterization of a potential malaria transmission-blocking vaccine candidate” Malar J. 18(1):356 (2019)

Rodriguez-Aponte SA, Dalvie NC, Wong TY, Johnston RS, Naranjo CA, Bajoria S, Kumru OS, Kaur K, Russ BP, Lee KS, Cyphert HA, Barbier M, Rao HD, Rajurkar MP, Lothe RR, Shaligram US, Batwal S, Chandrasekaran R, Nagar G, Kleanthous H, Biswas S, Bevere JR, Joshi SB, Volkin DB, Damron FH, Love JC “Molecular engineering of a cryptic epitope in Spike RBD improves manufacturability and neutralizing breadth against SARS-CoV-2 variants” Vaccine 41(5) 1108-1118 (2023)

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)

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, Nagar GS, Rao HD, Lothe RR, Chandrasekharan R, Rajurkar MP, Shaligram US, Kleanthous H, Joshi SB, Volkin DB, Biswas S, Love JC, Barouch DH. “SARS-CoV-2 receptor binding domain displayed on HBsAg virus-like particles elicits protective immunity in macaques” Sci. Adv 8(11):eabl6015 Epub (2022)

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) (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)

Hong MS, Kaur K, Sawant N, Joshi SB, Volkin DB, Braatz RD “Crystallization of a nonreplicating rotavirus vaccine candidate” Biotechnol Bioeng 118(4):1750-1756 (2021)

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 doi: 10.1002/btpr.2966 (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)