Peer-Reviewed Scientific Publications
47. McColl, E., Croyle M.A., Zamboni, W., Honer, W., Heise, M., Piquette-Miller, M., and Goralski, K. COVID-19 Vaccines and the Virus: Impact on Drug Metabolism and Pharmacokinetics (2023) Drug Metabolism and Disposition Jan. 51(1):130-141. doi: 10.1124/dmd.122.000934. Epub 2022 Oct 23.
46. Doan, T.N.K., Le M.D., Bajrovic, I., Celentano, L., Krause, C., Grooms Balyan, H., Svancarek, A., Wasala, L., Mote, A., Tretiakova, A., Samulski, R.J. and Croyle M.A. Thermostability and In Vivo Performance of AAV9 in a Film Matrix (2022) Communications Medicine 2(1):148.
45. Bajrovic I., Le, M.D., Davis, M.M., Croyle, M.A. Evaluation of Intermolecular Interactions Required for Thermostability of a Recombinant Adenovirus Within a Film Matrix (2022) Journal of Controlled Release 341:118-131.
44. Jonsson-Schmunk, K., Ghose, R. and Croyle. M.A. Immunization and Drug Metabolizing Enzymes: Focus on Hepatic Cytochrome P450 3A. (2021) Expert Review of Vaccines 20(5):623-634.
43. Bajrovic, I., Schafer, S.C., Romanovicz, D.K. and Croyle. M.A. Novel Technology for Storage and Distribution of Live Vaccines and Other Biological Medicines at Ambient Temperature. (2020) Science Advances 6(10):eaau4819. doi: 10.1126/sciadv.aau4819
** Featured in Scientific American and the subject of the BBC’s Science In Action podcast. In June 2020, was in top 5% of research papers tracked by Altmetrics in journal with regard to citation incidence.
42. Jonsson-Schmunk. K., Wonganan P., Choi JH., Callahan SM., Croyle, M.A. Integrin Receptors Play a Key Role in the Regulation of Hepatic Cytochrome P450 3A. (2016) Drug Metabolism and Disposition May;44(5):758-70. doi: 10.1124/dmd.115.068874. Epub 2016 Feb 11.
!! Figures from this manuscript were selected for use as cover art for the May 2016 issue of the journal.
41. Choi, J.H., Schafer, S.C., Freiberg, A.N., Croyle, M.A. Bolstering Components of the Immune Response Compromised by Prior Exposure to Adenovirus: Guided Formulation Development for a Nasal Ebola Vaccine. (2015) Molecular Pharmaceutics 12 (8):2697–2711.
!! Editor’s Choice Award from the American Chemical Society in recognition of the excellent science outlined in the paper and the novelty in which it addresses a current, very serious global issue.
40. Choi, J.H., Jonsson-Schmunk. K., Qiu, X., Shedlock, D.J., Strong, J., Xu, J.X., Michie, K.L., Audet, J., Fernando, L., Myers, M.J., Weiner, D., Bajrovic, I., Tran, L.Q., Wong, G., Bello, A., Kobinger, G.P., Schafer, S.C., Croyle, M.A. A Single Dose Respiratory Recombinant Adenovirus-Based Vaccine Provides Long-Term Protection for Non-Human Primates from Lethal Ebola Infection. (2015) Molecular Pharmaceutics 12 (8):2712–2731.
!! Editor’s Choice Award from the American Chemical Society in recognition of the excellent science outlined in the paper and the novelty in which it addresses a current very serious global issue.
39. Wonganan, P., Jonsson-Schmunk, K., Callahan, S.M., Choi, J.H. and Croyle, M.A. Evaluation of the HC-04 Cell Line as an In Vitro Model for Mechanistic Assessment of Changes in Hepatic Cytochrome P450 3A During Adenovirus Infection. (2014) Drug Metabolism and Disposition 42(7):1191-1201.
38. Choi, J.H., Schafer, S.C., Zhang, L., Juelich, T.J., Freiberg, A.N., and Croyle, M.A. Modeling Pre-Existing Immunity to Adenovirus in Rodents: Immunological Requirements for Successful Development of a Recombinant Adenovirus Serotype 5-Based Ebola Vaccine. (2013) Molecular Pharmaceutics 10(9):3342-3355.
37. Leggiero, E., Astone, D., Cerullo, V., Mazzaccara, C., Labruna, G., Sacchetti, L., Salvatore, F., Croyle, M.A. and Pastore, L. A PEGylated Helper-Dependent Adenoviral Vector Expressing Human Apo-A1 Reduces Atherosclerosis in LDLR Deficient Mice. (2013) Gene Therapy 20(12):1124-1130.
36. Shedlock, D.J., Aviles, J., Talbott, K.T., Wong, G., Wu, S.J., Villarreal, D.O., Myles, D.J.F., Croyle, M.A., Yan, J., Kobinger, G.P., and Weiner, D.B. Induction of Broad Cytotoxic T Cells by Protective DNA Vaccination Against Marburg and Ebola. (2013) Molecular Therapy 21(7):1432-1444
35. Choi, J.H., Dekker, J.D., Schafer, S.C., John, J., Whitfil, C.E., Petty, C.S., Haddad, E.E. and Croyle, M.A. Optimized adenovirus-antibody complexes stimulate strong cellular and humoral immune responses against an encoded antigen in naive mice and those with preexisting immunity. (2012) Clinical and Vaccine Immunology 19(1), 84-95.
34. Choi, J.H., Schafer, S.C., Zhang, L., Kobinger, G.P., Juelich, T.J., Freiberg, A.N., and Croyle, M.A. A Single Sublingual Dose of an Adenovirus-based Vaccine Protects Against Lethal Ebola Challenge in Mice and Guinea Pigs. (2012) Molecular Pharmaceutics 9(1), 156-167.
33. Wonganan P, Clemens CC, Brasky K, Pastore L, and Croyle M.A. Species Differences in the Pharmacology and Toxicology of PEGylated Helper-Dependent Adenovirus. (2011) Molecular Pharmaceutics 8(1):78-92. doi:10.1021/mp100216h.
32. Renteria, S.S., Clemens, C.C., Wonganan, P.W., and Croyle, M.A. Effects of Concentration and Formulation on Adenovirus Stability and Infectious Titer During Actuation from Two Intranasal Delivery Devices. (2010) Vaccine Feb 25;28(9):2137-48. doi: 10.1016/j.vaccine.2009.12.025. Epub 2009 Dec 29
31. Wonganan, P., Zamboni, W.C., Strychor, S., Dekker, J.D. and Croyle, M.A. Drug-Virus Interaction: Effect of Administration of Recombinant Adenoviruses on the Pharmacokinetics of Docetaxel in a Rat Model. (2009) Cancer Gene Therapy 16(5):405-14.
30. Richardson, J.S., Yao, M.K., Tran, K.N., Croyle, M.A., Strong, J.E., Feldmann, H., and Kobinger, G.P. Enhanced protection against Ebola virus mediated by an improved adenovirus-based vaccine. (2009) PLoS ONE. 4(4):e5308.
29. Croyle, M., Patel, A., Tran, K., Gray, M., Zhang, Y., Strong, J., Feldmann, H., and Kobinger, G.P. Nasal Delivery of an Adenovirus-Based Vaccine Bypasses Pre-Existing Immunity to the Vaccine Carrier and Improves The Immune Response In Mice. (2008) PLoS One. 3(10):e3548.
28. Callahan, S.M., Wonganan, P., and Croyle, M.A. Molecular and Macromolecular Alterations of Recombinant Adenoviral Vectors Do Not Resolve Changes in Hepatic Drug Metabolism During Infection. (2008) Virology Journal Sept. 30 5:111.
27. Boquet, M.P., Wonganan, P., Dekker, J.D., and Croyle, M.A. Influence of Method of Systemic Administration of Adenovirus on Virus-Mediated Toxicity: Focus on Mortality, Virus Distribution, and Drug Metabolism. (2008) Journal of Pharmacological and Toxicological Methods 58(3):222-32.
26. Callahan, S.M., Wonganan, P., Obenauer-Kutner, L.J., Sutjipto, S., Dekker, J.D., and Croyle, M.A. Controlled Inactivation of Recombinant Viruses with Vitamin B2 (2008) Journal of Virological Methods 148(1-2):132-145.
25. Patel, A., Zhang, Y., Croyle, M., Gray, M., Strong, J., Feldmann, H., Wilson, J.M. and Kobinger, G.P. Mucosal Delivery of Adenovirus-Based Vaccine Protects Against Ebola Virus Infection. (2007) Journal of Infectious Diseases 196(Suppl. 2):S413-S420.
24. Le, H.T., Boquet, M.P., Clark, E.A., Callahan, S.M. and Croyle, M.A. Renal Pathophysiology after Systemic Administration of Recombinant Adenovirus: Changes in Renal Cytochromes P450 Based upon Vector Dose. (2006) Human Gene Therapy 17(11):1095-1111.
23. Callahan, S.M., Boquet, M.P., Ming, X., Brunner, L.J., and Croyle, M.A. Impact of Transgene Expression on Drug Metabolism Following Systemic Adenoviral Vector Administration. (2006) Journal of Gene Medicine 8(5):566-576.
22. Le, H.T., Yu, Q.C., Wilson, J.M. and Croyle, M.A. Utility of PEGylated Recombinant Adeno-Associated Viruses for Gene Transfer. (2005) Journal of Controlled Release 108(1):161-177.
21. Croyle, M.A., Le, H., Linse, K., Ming, X., Toietta, G., Beaudet, A., and Pastore, L. PEGylated Helper-Dependent Adenoviral Vectors: Highly Efficient Vectors with an Enhanced Safety Profile. (2005) Gene Therapy 12(7):579-588.
20. Callahan, S.M., Ming, X., Lu, S.K., Brunner, L.J., and Croyle, M.A. Consideration for Use of Recombinant Adenoviral Vectors: Dose Effect on Hepatic Cytochromes P450. (2005) Journal of Pharmacology and Experimental Therapeutics 312(2):492-501.
19. Croyle, M.A. Callahan, S.M., Auricchio, A., Schumer, G., Wilson, J.M., Linse, K., Brunner, L.J., and Kobinger, G.P. PEGylation of a Vesicular Stomatitis Virus G Pseudotyped Lentiviral Vector Prevents Inactivation in Serum. (2004) Journal of Virology 78(2):912-921.
18. Quick, K.S. Gerding, K., and Croyle, M.A. Role of Container/Closure System and Formulation on Agitation-Induced Aggregation Phenomena in Recombinant Adenoviral Products. (2003) BioProcessing 2(5):35-41.
17. Cheng, X., Ming, X., and Croyle, M.A. PEGylated Adenoviruses Enhance Gene Delivery to the Intestinal Epithelium by the Oral Route. (2003) Pharmaceutical Research 20(9):1444-1451.
16. Lehmberg, E., Shabram, P., Schluep, T., Wen, S.F., Sugarman, B., Croyle, M., Koehl, M., Bonfils, E., Malarme, D., Sharpe, G., Nesbit, H., Borellini, F., Kamen, A., Hutchins, B. and Vellekamp, G. Adenovirus Reference Material - Determination of Particle Concentrations obtained by orthogonal, physical - chemical methods. (2003) BioProcessing 2(3):50-56.
15. Adadevoh, K., Croyle, M.A., Malarme, D., Bonfils, E., and Bowe, M.A. A Short Term Field Use and Shipping Stability Study of a Wild Type Ad5 Adenoviral Reference Material. (2002) BioProcessing 1(3):62-69.
14. Croyle, M. A., Chirmule, N., Zhang, Y., and Wilson, James M. PEGylation of E-1 Deleted Adenovirus Vectors Allows Significant Gene Expression upon Re-administration to Liver. (2002) Human Gene Therapy 13(15):1887-1900.
13. Croyle, M.A., Cheng, X., and Wilson, J.M. Development of Formulations that Enhance the Physical Stability of Viral Vectors for Human Gene Therapy. (2001) Gene Therapy 8(17):1281-1291.
12. Croyle, M.A., Cheng, X., Sandhu, A., and Wilson, J.M. Development of Novel Formulations that Enhance Adenoviral-Mediated Gene Expression to the Lung In Vitro and In Vivo. (2001) Molecular Therapy 4(1):22-28.
11. Zhang, Y., Chirmule, N., Gao, G.P., Qian, R., Croyle, M., Joshi, B., Tazelaar, J., and Wilson, J.M. Acute Cytokine Response to Systemic Adenoviral Vectors is Mediated by Dendritic Cells and Macrophages. (2001) Molecular Therapy 3(5):697-707.
10. Croyle, M.A., Chirmule, N., Zhang, Y., and Wilson, James M. "Stealth" Adenoviruses Blunt Cell Mediated and Humoral Immune Responses Against the Virus and Allow for Significant Gene Expression upon Re-administration for Gene Therapy to the Lung. (2001) Journal of Virology 75(10):4792-4801.
9. Croyle, M.A., Yu, Q.C. and Wilson, J.M. Development of a Rapid Method for the PEGylation of Adenoviruses with Enhanced Transduction and Improved Stability Under Harsh Storage Conditions. (2000) Human Gene Therapy 11:1721-1730.
8. Yu Q.C., Ma X., Croyle M., Qu G., Huang J., Gao G.P., Hughes J., Wilson J.M. Electron microscopic evaluation of vector quality for gene therapy. (2000) Microscopy and Microanalysis 6:858-859.
7. Croyle, M.A., Anderson, D.J., Roessler, B.J., and Amidon, G.L. Development of a Highly Efficient Purification Process for Recombinant Adenoviral Vectors for Oral Gene Delivery. (1998) Pharmaceutical Development and Technology 3(3):365-372.
6. Croyle, M.A., Roessler, B.J., Davidson, B.L., Hilfinger, J.M., and Amidon, G.L. Factors that Influence Stability of Recombinant Adenoviral Preparations for Human Gene Therapy. (1998) Pharmaceutical Development and Technology 3(3):373-383.
5. Croyle, M.A., Roessler, B.J., Hsu, C.P., Sun, R. and Amidon, G.L. Beta Cyclodextrins Enhance Adenoviral-Mediated Gene Delivery to the Intestine. (1998) Pharmaceutical Research 15(9):1348-1355.
4. Croyle, M.A., Stone, M., Amidon, G.L., and Roessler, B.J. In vitro and In vivo Assessment of Adenovirus 41 as a Vector for Gene Delivery to the Intestine. (1998) Gene Therapy, 5(5):645-654.
3. Croyle, M.A., Walter, E., Janich, S., Roessler, B.J., and Amidon, G.L. Role of Integrin Expression in Adenovirus-Mediated Gene Delivery to the Intestinal Epithelium. (1998) Human Gene Therapy 9(4):561-573.
2. Walter, E., Croyle, M.A., Davidson, B.L., Roessler, B.J., Hilfinger, J.M., Amidon, G.L. Adenovirus-mediated Gene Transfer to Intestinal Epithelial Cells as a Potential Approach for Oral Delivery of Peptides and Proteins. (1997) Journal of Controlled Release 46(1-2):75-87.
1. Walter, E., Croyle, M.A., Roessler, B.J., and Amidon, G.L. The Absence of Accessible Vitronectin Receptors in Differentiated Tissue Hinders Adenoviral-Mediated Gene Transfer to the Intestinal Epithelium In Vitro. (1997) Pharmaceutical Research 14(9):1216-1222.
Invited Reviews / Editorials in Peer-Reviewed Journals
8. Croyle, M.A. We Have Arrived at a Time when the Bottom is Starting to Fill Up! (2018) Journal of Pharmaceutical Investigation 48(1): 1-2.
7. Jonsson-Schmunk. K., Schafer, S.C. and Croyle, M.A. Impact of Nanomedicine on Hepatic Cytochrome P450 3A4 Activity: Things to Consider During Pre-Clinical and Clinical Studies. (2017) Journal of Pharmaceutical Investigation 48(1):113-134.
6. Jonsson-Schmunk. K., and Croyle, M.A. A Respiratory Vaccine for Ebola: Close to a Reality? (2015) Future Virology 10(6):659-662.
5. Jonsson-Schmunk. K., Croyle, M.A. A Long-Lasting, Single-Dose Nasal Vaccine for Ebola: A Practical Armament for an Outbreak with Significant Global Impact. (2015) Expert Review of Anti-infective Therapy 13:5, 527-530.
4. Choi, J.H. and Croyle, M.A. Emerging Targets and Novel Approaches to Ebola Virus Prophylaxis and Treatment. (2013) BioDrugs 27(6), 565-583.
** This manuscript was one of the most cited papers for the journal in the second quarter of 2015
3. Richardson, J.S., Dekker, J.D., Croyle, M.A., and Kobinger, G.P. Recent Advances in Ebola Vaccine Development (2010) Human Vaccines 6(6):439-449.
2. Wonganan, P., and Croyle, M.A. PEGylated Adenoviruses: From Mice to Monkeys. (2010) Viruses 2(2): 468-502 doi:10.3390/v2020468.
1. Croyle, M.A. Long-Term Virus-Induced Alterations of CYP3A-Mediated Drug Metabolism: A Look at the Virology, Immunology and Molecular Biology of a Multi-Faceted Problem. (2009) Expert Opinion on Drug Metabolism and Toxicology 5(10), 1189-211.
Invited Book Chapters
2. Kobinger, G.P., Croyle, M.A., and Feldmann, H.. Filoviruses. In: Vaccines for Biodefense and Emerging and Neglected Diseases, Eds. Barrett, A. D. T. and Stanberry, L. R. (2008) New York: Elsevier pp.323-336.
1. Croyle, M.A. Gene Therapy. In: Crommelin, D. Sindelar, E. and Meibohm B., Eds. Pharmaceutical Biotechnology: Fundamentals and Applications. 3rd Ed. (2007) New York: Informa Healthcare pp:175-210. ISBN-13: 9781420044379 ISBN-10: 1420044370
Patents Granted from Maria Croyle’s Research
Methods and Compositions for Transport, Storage and Delivery of Nucleic Acids and other Molecules
Inventors: Maria A. Croyle and Trang N.K. Doan
2022-09-29 Application 63/411,460 Filed
Methods and Compositions for Transport, Storage and Delivery of Adeno-Associated Viral Vectors and other Molecules
Inventors: Maria A. Croyle and Trang N.K. Doan
2021-05-21 Application PCT/US22/28009 Filed
Dissolvable films and methods of their use
Abstract: Soluble film compositions comprising biologically active polypeptides are provided, which stabilize the polypeptides. Methods for administering, formulating and stabilizing polypeptides are also provided.
Assignee: Board of Regents, The University of Texas System
Inventors: Maria A. Croyle, Stephen Clay Schafer
2018-05-11 Publication of WO2018085495A2
2018-06-21 Publication of WO2018085495A3
2019-09-11 Publication of EP3534974A2
2020-07-01 Publication of EP3534974A4
2022-10-13 Publication of US20220323587A1
Immunogenic compositions and uses thereof
Abstract: Immunogenic compositions comprising viral vectors and surfactants are provided. Methods for administration and preparation of such compositions are also provided.
Assignee: Board of Regents, The University of Texas System
Inventors: Maria A. Croyle, Stephen Clay Schafer
2016-10-13 Publication of US20160296616A1
2018-05-22 Publication of US9974850B2
2018-11-15 Publication of US20180326036A1
2019-05-07 Publication of US10279029B2
2019-10-17 Publication of US20190314480A1
2020-08-25 Publication of US10751409B2
2020-11-12 Publication of US20200353068A1
2022-03-24 Publication of US20220088171A1
Methods for inducing an immune response via buccal and/or sublingual administration of a vaccine
Abstract: Vaccine compositions that may be administered to a subject via the buccal and/or sublingual mucosa are provided. Methods for administration and preparation of such vaccine compositions are also provided.
Assignee: Board of Regents, The University of Texas System
Inventors: Maria A. Croyle, Jun Huk Choi, Stephen C. Schafer
2012-02-09 Publication of WO2012018628A1
2014-05-01 Publication of US20140120139A1
2017-06-13 Publication of US9675550B2
2018-01-04 Publication of US20180000724A1
2020-05-12 Publication of US10646438B2
2022-03-31 Publication of US20220096368A1
Methods for rapid PEG-modification of viral vectors, compositions for enhanced gene transduction, compositions with enhanced physical stability, and uses therefor
Abstract: A rapid method for modifying a viral capsid or envelope protein with a polyethylene glycol (PEG) is described. Also provided are methods of delivering a molecule using the PEG-modified viruses of the invention. Compositions containing the PEG-modified viruses of the invention, are characterized by improved gene expression, reduced neutralizing antibody and CTL production. Also provided are viral compositions having enhanced physical stability, in which the viruses are lyophilized in a formulation having a 1:1 ratio of sucrose and mannitol are provided.
Assignee: The Trustees of the University of Pennsylvania
Inventors: Maria Croyle, James M. Wilson
2002-06-04 Publication of US6399385B1