Colorado PROFILES, The Colorado Clinical and Translational Sciences Institute (CCTSI)
Keywords
Last Name
Institution
Menu

Contact Us
If you have any questions or feedback please contact us.

Theodore W Randolph

TitleProfessor
InstitutionUniversity of Colorado Boulder
DepartmentChemical & Biological Engin
Phone303/492-4776
    Other Positions
    TitleEndowed or Named Professor
    InstitutionUniversity of Colorado Boulder
    DepartmentCollege Engineering & App Sci

    TitleProfessor
    InstitutionUniversity of Colorado Boulder
    DepartmentChemical & Biological Engin


    Collapse Research 
    Collapse research activities and funding
    R43GM153054     (CALDERON, CHRISTOPHER PETER)May 15, 2024 - Apr 30, 2025
    NIH
    High-Throughput, Label-Free, Unsupervised Image Analysis of CAR-T Cell Data
    Role: Co-Principal Investigator
    R43EB029863     (CALDERON, CHRISTOPHER PETER)Sep 16, 2020 - Sep 15, 2021
    NIH
    A New Tool to Rapidly Diagnose Sepsis using Flow Imaging Microscopy and Machine Learning
    Role: Co-Principal Investigator
    R41GM130513     (CALDERON, CHRISTOPHER PETER)Aug 1, 2018 - Jul 31, 2021
    NIH
    Quantitative Biotherapeutic Particle Characterization via Deep Neural Networks
    Role: Co-Principal Investigator
    R21EB026006     (GOODWIN, ANDREW P)Apr 1, 2018 - Oct 31, 2020
    NIH
    Effect of Container Surface Structure on Cavitation-Induced Protein Particulate Formation
    Role: Co-Principal Investigator
    R01EB006006     (RANDOLPH, THEODORE W)Sep 15, 2006 - Sep 30, 2018
    NIH
    Biotechnology Research Partnerships Renewal: Aggregation of Therapeutic Proteins
    Role: Principal Investigator
    T32GM008732     (RANDOLPH, THEODORE W)Jul 1, 2001 - Jun 30, 2016
    NIH
    Leadership Training in Pharmaceutical Biotechnology
    Role: Principal Investigator

    Collapse Bibliographic 
    Collapse selected publications
    Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.
    List All   |   Timeline
    1. Coleman H, Saylor Perez J, Schwartz DK, Kaar J, Garcea RL, Randolph TW. Effect of mechanical stresses on viral capsid disruption during droplet formation and drying. Colloids Surf B Biointerfaces. 2024 Jan; 233:113661. PMID: 38006709.
      View in: PubMed
    2. Thite NG, Ghazvini S, Wallace N, Feldman N, Calderon CP, Randolph TW. Interfacial Adsorption Controls Particle Formation in Antibody Formulations Subjected to Extensional Flows and Hydrodynamic Shear. J Pharm Sci. 2023 Nov; 112(11):2766-2777. PMID: 37453529.
      View in: PubMed
    3. Witeof AE, Meinerz NM, Walker KD, Funke HH, Garcea RL, Randolph TW. A Single Dose, Thermostable, Trivalent Human Papillomavirus Vaccine Formulated Using Atomic Layer Deposition. J Pharm Sci. 2023 08; 112(8):2223-2229. PMID: 36780987.
      View in: PubMed
    4. Greenblott DN, Zhang J, Calderon CP, Randolph TW. Machine learning approaches to root cause analysis, characterization, and monitoring of subvisible particles in monoclonal antibody formulations. Biotechnol Bioeng. 2022 12; 119(12):3596-3611. PMID: 36124935.
      View in: PubMed
    5. Thite NG, Ghazvini S, Wallace N, Feldman N, Calderon CP, Randolph TW. Machine Learning Analysis Provides Insight into Mechanisms of Protein Particle Formation Inside Containers During Mechanical Agitation. J Pharm Sci. 2022 10; 111(10):2730-2744. PMID: 35835184.
      View in: PubMed
    6. Preston KB, Wong TAS, Lieberman MM, To A, Lai CY, Granados A, Thomasson H, Misamore J, Yalley-Ogunro J, Cabus M, Andersen H, Donini O, Lehrer AT, Randolph TW. Lyophilized Filovirus Glycoprotein Vaccines: Peroxides in a Vaccine Formulation with Polysorbate 80-Containing Adjuvant are Associated with Reduced Neutralizing Antibody Titers in Both Mice and Non-Human Primates. J Pharm Sci. 2022 12; 111(12):3424-3434. PMID: 35609629.
      View in: PubMed
    7. Calderon CP, Ripple DC, Srinivasan C, Ma Y, Carrier MJ, Randolph TW, O'Connor TF. Testing Precision Limits of Neural Network-Based Quality Control Metrics in High-Throughput Digital Microscopy. Pharm Res. 2022 Feb; 39(2):263-279. PMID: 35080706.
      View in: PubMed
    8. Witeof AE, McClary WD, Rea LT, Yang Q, Davis MM, Funke HH, Catalano CE, Randolph TW. Atomic-Layer Deposition Processes Applied to Phage ? and a Phage-like Particle Platform Yield Thermostable, Single-Shot Vaccines. J Pharm Sci. 2022 05; 111(5):1354-1362. PMID: 35081408.
      View in: PubMed
    9. Benkstein KD, Balakrishnan G, Bhirde A, Chalus P, Das TK, Do N, Duewer DL, Filonov N, Cheong FC, Garidel P, Gill NS, Grabarek AD, Grier DG, Hadley J, Hollingsworth AD, Howard WW, Jarzebski M, Jiskoot W, Kar SR, Kestens V, Khasa H, Kim YJ, Koulov A, Matter A, Philips LA, Probst C, Ramaye Y, Randolph TW, Ripple DC, Romeijn S, Saggu M, Schleinzer F, Snell JR, Tatarkiewicz JK, Wright HA, Yang DT. An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion. J Pharm Sci. 2022 03; 111(3):699-709. PMID: 34808214.
      View in: PubMed
    10. Dong M, Meinerz NM, Walker KD, Garcea RL, Randolph TW. Thermostability of a trivalent, capsomere-based vaccine for human papillomavirus infection. Eur J Pharm Biopharm. 2021 Nov; 168:131-138. PMID: 34438020.
      View in: PubMed
    11. Preston KB, Wong TAS, To A, Tashiro TE, Lieberman MM, Granados A, Feliciano K, Harrison J, Yalley-Ogunro J, Elyard HA, Donini O, Lehrer AT, Randolph TW. Single-vial filovirus glycoprotein vaccines: Biophysical characteristics and immunogenicity after co-lyophilization with adjuvant. Vaccine. 2021 09 15; 39(39):5650-5657. PMID: 34400019.
      View in: PubMed
    12. Movafaghi S, Daniels AL, Kelly MD, Witeof AE, Calderon CP, Randolph TW, Goodwin AP. Hydrogel Coatings on Container Surfaces Reduce Protein Aggregation Caused by Mechanical Stress and Cavitation. ACS Appl Bio Mater. 2021 09 20; 4(9):6946-6953. PMID: 35006994.
      View in: PubMed
    13. Wu H, Movafaghi S, Francino Urd?niz IM, Rowe TM, Goodwin A, Randolph TW. Insulin Fibril Formation Caused by Mechanical Shock and Cavitation. J Phys Chem B. 2021 07 29; 125(29):8021-8027. PMID: 34260251.
      View in: PubMed
    14. Witeof AE, Daniels AL, Rea LT, Movafaghi S, Kurtz K, Davis M, Eveland RW, Calderon CP, Randolph TW. Machine Learning and Accelerated Stress Approaches to Differentiate Potential Causes of Aggregation in Polyclonal Antibody Formulations During Shipping. J Pharm Sci. 2021 07; 110(7):2743-2752. PMID: 33647275.
      View in: PubMed
    15. Preston KB, Randolph TW. Stability of lyophilized and spray dried vaccine formulations. Adv Drug Deliv Rev. 2021 04; 171:50-61. PMID: 33484735.
      View in: PubMed
    16. Preston KB, Monticello CR, Wong TAS, To A, Donini O, Lehrer AT, Randolph TW. Preservation of Quaternary Structure in Thermostable, Lyophilized Filovirus Glycoprotein Vaccines: A Search for Stability-Indicating Assays. J Pharm Sci. 2020 12; 109(12):3716-3727. PMID: 32931778.
      View in: PubMed
    17. Daniels AL, Calderon CP, Randolph TW. Machine learning and statistical analyses for extracting and characterizing "fingerprints" of antibody aggregation at container interfaces from flow microscopy images. Biotechnol Bioeng. 2020 11; 117(11):3322-3335. PMID: 32667683.
      View in: PubMed
    18. Movafaghi S, Wu H, Francino Urd?niz IM, Bull DS, Kelly MD, Randolph TW, Goodwin AP. The Effect of Container Surface Passivation on Aggregation of Intravenous Immunoglobulin Induced by Mechanical Shock. Biotechnol J. 2020 Sep; 15(9):e2000096. PMID: 32437086.
      View in: PubMed
    19. Garcea RL, Meinerz NM, Dong M, Funke H, Ghazvini S, Randolph TW. Single-administration, thermostable human papillomavirus vaccines prepared with atomic layer deposition technology. NPJ Vaccines. 2020; 5(1):45. PMID: 32528733.
      View in: PubMed
    20. Wu H, Randolph TW. Aggregation and Particle Formation During Pumping of an Antibody Formulation Are Controlled by Electrostatic Interactions Between Pump Surfaces and Protein Molecules. J Pharm Sci. 2020 04; 109(4):1473-1482. PMID: 32004539.
      View in: PubMed
    21. Her C, Tanenbaum LM, Bandi S, Randolph TW, Thirumangalathu R, Mallela KMG, Carpenter JF, Elias Y. Effects of Tubing Type, Operating Parameters, and Surfactants on Particle Formation During Peristaltic Filling Pump Processing of a mAb Formulation. J Pharm Sci. 2020 04; 109(4):1439-1448. PMID: 31954724.
      View in: PubMed
    22. Wu H, Chisholm CF, Puryear M, Movafaghi S, Smith SD, Pokhilchuk Y, Lengsfeld CS, Randolph TW. Container Surfaces Control Initiation of Cavitation and Resulting Particle Formation in Protein Formulations After Application of Mechanical Shock. J Pharm Sci. 2020 03; 109(3):1270-1280. PMID: 31758950.
      View in: PubMed
    23. Chisholm CF, Behnke W, Pokhilchuk Y, Frazer-Abel AA, Randolph TW. Subvisible Particles in IVIg Formulations Activate Complement in Human Serum. J Pharm Sci. 2020 01; 109(1):558-565. PMID: 31672401.
      View in: PubMed
    24. Snell JR, Monticello CR, Her C, Ross EL, Frazer-Abel AA, Carpenter JF, Randolph TW. DEHP Nanodroplets Leached From Polyvinyl Chloride IV Bags Promote Aggregation of IVIG and Activate Complement in Human Serum. J Pharm Sci. 2020 01; 109(1):429-442. PMID: 31229435.
      View in: PubMed
    25. Snell JR, Kumar NSK, Suryanarayanan R, Randolph TW. Nanobubbles in Reconstituted Lyophilized Formulations: Interaction With Proteins and Mechanism of Formation. J Pharm Sci. 2020 01; 109(1):284-292. PMID: 31095959.
      View in: PubMed
    26. Gandhi AV, Randolph TW, Carpenter JF. Conjugation of Emtansine Onto Trastuzumab Promotes Aggregation of the Antibody-Drug Conjugate by Reducing Repulsive Electrostatic Interactions and Increasing Hydrophobic Interactions. J Pharm Sci. 2019 06; 108(6):1973-1983. PMID: 30735687.
      View in: PubMed
    27. Chisholm CF, Kang TJ, Dong M, Lewis K, Namekar M, Lehrer AT, Randolph TW. Thermostable Ebola virus vaccine formulations lyophilized in the presence of aluminum hydroxide. Eur J Pharm Biopharm. 2019 Mar; 136:213-220. PMID: 30703544.
      View in: PubMed
    28. Sorret LL, Monticello CR, DeWinter MA, Schwartz DK, Randolph TW. Steric Repulsion Forces Contributed by PEGylation of Interleukin-1 Receptor Antagonist Reduce Gelation and Aggregation at the Silicone Oil-Water Interface. J Pharm Sci. 2019 Jan; 108(1):162-172. PMID: 30395835.
      View in: PubMed
    29. Wu H, Randolph TW. Rapid Quantification of Protein Particles in High-Concentration Antibody Formulations. J Pharm Sci. 2019 03; 108(3):1110-1116. PMID: 30773198.
      View in: PubMed
    30. Qi W, Orgel S, Francon A, Randolph TW, Carpenter JF. Urea Improves Stability of Inactivated Polio Vaccine Serotype 3 During Lyophilization and Storage in Dried Formulations. J Pharm Sci. 2018 08; 107(8):2070-2078. PMID: 29709487.
      View in: PubMed
    31. Nejadnik MR, Randolph TW, Volkin DB, Sch?neich C, Carpenter JF, Crommelin DJA, Jiskoot W. Postproduction Handling and Administration of Protein Pharmaceuticals and Potential Instability Issues. J Pharm Sci. 2018 08; 107(8):2013-2019. PMID: 29665382.
      View in: PubMed
    32. Pardeshi NN, Zhou C, Randolph TW, Carpenter JF. Protein Nanoparticles Promote Microparticle Formation in Intravenous Immunoglobulin Solutions During Freeze-Thawing and Agitation Stresses. J Pharm Sci. 2018 07; 107(7):1852-1857. PMID: 29601840.
      View in: PubMed
    33. Sorret LL, DeWinter MA, Schwartz DK, Randolph TW. Protein-protein interactions controlling interfacial aggregation of rhIL-1ra are not described by simple colloid models. Protein Sci. 2018 07; 27(7):1191-1204. PMID: 29388282.
      View in: PubMed
    34. Daniels AL, Randolph TW. Flow Microscopy Imaging Is Sensitive to Characteristics of Subvisible Particles in Peginesatide Formulations Associated With Severe Adverse Reactions. J Pharm Sci. 2018 05; 107(5):1313-1321. PMID: 29409840.
      View in: PubMed
    35. Calderon CP, Daniels AL, Randolph TW. Deep Convolutional Neural Network Analysis of Flow Imaging Microscopy Data to Classify Subvisible Particles in Protein Formulations. J Pharm Sci. 2018 04; 107(4):999-1008. PMID: 29269269.
      View in: PubMed
    36. Randolph TW. Response to Comment to the Editor. Biophys J. 2017 08 08; 113(3):755-756. PMID: 28793229.
      View in: PubMed
    37. Chisholm CF, Soucie KR, Song JS, Strauch P, Torres RM, Carpenter JF, Ragheb JA, Randolph TW. Immunogenicity of Structurally Perturbed Hen Egg Lysozyme Adsorbed to Silicone Oil Microdroplets in Wild-Type and Transgenic Mouse Models. J Pharm Sci. 2017 06; 106(6):1519-1527. PMID: 28216023.
      View in: PubMed
    38. Maddux NR, Daniels AL, Randolph TW. Microflow Imaging Analyses Reflect Mechanisms of Aggregate Formation: Comparing Protein Particle Data Sets Using the Kullback-Leibler Divergence. J Pharm Sci. 2017 05; 106(5):1239-1248. PMID: 28159641.
      View in: PubMed
    39. Sorret LL, DeWinter MA, Schwartz DK, Randolph TW. Challenges in Predicting Protein-Protein Interactions from Measurements of Molecular Diffusivity. Biophys J. 2016 Nov 01; 111(9):1831-1842. PMID: 27806265.
      View in: PubMed
    40. Snell JR, Zhou C, Carpenter JF, Randolph TW. Particle Formation and Aggregation of a Therapeutic Protein in Nanobubble Suspensions. J Pharm Sci. 2016 10; 105(10):3057-3063. PMID: 27488901.
      View in: PubMed
    41. Mehta SB, Carpenter JF, Randolph TW. Colloidal Instability Fosters Agglomeration of Subvisible Particles Created by Rupture of Gels of a Monoclonal Antibody Formed at Silicone Oil-Water Interfaces. J Pharm Sci. 2016 08; 105(8):2338-48. PMID: 27422087.
      View in: PubMed
    42. Zhou C, Qi W, Lewis EN, Randolph TW, Carpenter JF. Reduced Subvisible Particle Formation in Lyophilized Intravenous Immunoglobulin Formulations Containing Polysorbate 20. J Pharm Sci. 2016 08; 105(8):2302-9. PMID: 27290624.
      View in: PubMed
    43. Zhou C, Cleland D, Snell J, Qi W, Randolph TW, Carpenter JF. Formation of Stable Nanobubbles on Reconstituting Lyophilized Formulations Containing Trehalose. J Pharm Sci. 2016 07; 105(7):2249-53. PMID: 27287517.
      View in: PubMed
    44. Jiskoot W, Kijanka G, Randolph TW, Carpenter JF, Koulov AV, Mahler HC, Joubert MK, Jawa V, Narhi LO. Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges. J Pharm Sci. 2016 05; 105(5):1567-1575. PMID: 27044944.
      View in: PubMed
    45. Chisholm CF, Baker AE, Soucie KR, Torres RM, Carpenter JF, Randolph TW. Silicone Oil Microdroplets Can Induce Antibody Responses Against Recombinant Murine Growth Hormone in Mice. J Pharm Sci. 2016 05; 105(5):1623-1632. PMID: 27020987.
      View in: PubMed
    46. Gerhardt A, Mcumber AC, Nguyen BH, Lewus R, Schwartz DK, Carpenter JF, Randolph TW. Surfactant Effects on Particle Generation in Antibody Formulations in Pre-filled Syringes. J Pharm Sci. 2015 Dec; 104(12):4056-4064. PMID: 26413998.
      View in: PubMed
    47. Christie M, Peritt D, Torres RM, Randolph TW, Carpenter JF. The Role of Protein Excipient in Driving Antibody Responses to Erythropoietin. J Pharm Sci. 2015 Dec; 104(12):4041-4055. PMID: 26375484.
      View in: PubMed
    48. Chisholm CF, Nguyen BH, Soucie KR, Torres RM, Carpenter JF, Randolph TW. In Vivo Analysis of the Potency of Silicone Oil Microdroplets as Immunological Adjuvants in Protein Formulations. J Pharm Sci. 2015 Nov; 104(11):3681-3690. PMID: 26190624.
      View in: PubMed
    49. McUmber AC, Randolph TW, Schwartz DK. Electrostatic Interactions Influence Protein Adsorption (but Not Desorption) at the Silica-Aqueous Interface. J Phys Chem Lett. 2015 Jul 02; 6(13):2583-7. PMID: 26266737.
      View in: PubMed
    50. McUmber AC, Larson NR, Randolph TW, Schwartz DK. Molecular trajectories provide signatures of protein clustering and crowding at the oil/water interface. Langmuir. 2015 Jun 02; 31(21):5882-90. PMID: 25950404.
      View in: PubMed
    51. Hassett KJ, Meinerz NM, Semmelmann F, Cousins MC, Garcea RL, Randolph TW. Development of a highly thermostable, adjuvanted human papillomavirus vaccine. Eur J Pharm Biopharm. 2015 Aug; 94:220-8. PMID: 25998700.
      View in: PubMed
    52. Gerhardt A, Nguyen BH, Lewus R, Carpenter JF, Randolph TW. Effect of the siliconization method on particle generation in a monoclonal antibody formulation in pre-filled syringes. J Pharm Sci. 2015 May; 104(5):1601-9. PMID: 25740412.
      View in: PubMed
    53. Shomali M, Tanriverdi S, Freitag AJ, Engert J, Winter G, Siedler M, Kaymakcalan Z, Carpenter JF, Randolph TW. Dose levels in particulate-containing formulations impact anti-drug antibody responses to murine monoclonal antibody in mice. J Pharm Sci. 2015 May; 104(5):1610-21. PMID: 25737325.
      View in: PubMed
    54. Mehta SB, Lewus R, Bee JS, Randolph TW, Carpenter JF. Gelation of a monoclonal antibody at the silicone oil-water interface and subsequent rupture of the interfacial gel results in aggregation and particle formation. J Pharm Sci. 2015 Apr; 104(4):1282-90. PMID: 25639229.
      View in: PubMed
    55. Hassett KJ, Vance DJ, Jain NK, Sahni N, Rabia LA, Cousins MC, Joshi S, Volkin DB, Middaugh CR, Mantis NJ, Carpenter JF, Randolph TW. Glassy-state stabilization of a dominant negative inhibitor anthrax vaccine containing aluminum hydroxide and glycopyranoside lipid A adjuvants. J Pharm Sci. 2015 Feb; 104(2):627-39. PMID: 25581103.
      View in: PubMed
    56. Randolph TW, Schiltz E, Sederstrom D, Steinmann D, Mozziconacci O, Sch?neich C, Freund E, Ricci MS, Carpenter JF, Lengsfeld CS. Do not drop: mechanical shock in vials causes cavitation, protein aggregation, and particle formation. J Pharm Sci. 2015 Feb; 104(2):602-11. PMID: 25418950.
      View in: PubMed
    57. Holm LS, Mcumber A, Rasmussen JE, Obiols-Rabasa M, Thulstrup PW, Kasimova MR, Randolph TW, van de Weert M. The effect of protein PEGylation on physical stability in liquid formulation. J Pharm Sci. 2014 Oct; 103(10):3043-54. PMID: 25139193.
      View in: PubMed
    58. Freitag AJ, Shomali M, Michalakis S, Biel M, Siedler M, Kaymakcalan Z, Carpenter JF, Randolph TW, Winter G, Engert J. Investigation of the immunogenicity of different types of aggregates of a murine monoclonal antibody in mice. Pharm Res. 2015 Feb; 32(2):430-44. PMID: 25123991.
      View in: PubMed
    59. Teska BM, Alarc?n J, Pettis RJ, Randolph TW, Carpenter JF. Effects of phenol and meta-cresol depletion on insulin analog stability at physiological temperature. J Pharm Sci. 2014 Aug; 103(8):2255-67. PMID: 24909933.
      View in: PubMed
    60. Devineni D, Gonschorek C, Cicerone MT, Xu Y, Carpenter JF, Randolph TW. Storage stability of keratinocyte growth factor-2 in lyophilized formulations: Effects of formulation physical properties and protein fraction at the solid-air interface. Eur J Pharm Biopharm. 2014 Oct; 88(2):332-41. PMID: 24859390.
      View in: PubMed
    61. Liu L, Braun LJ, Wang W, Randolph TW, Carpenter JF. Freezing-induced perturbation of tertiary structure of a monoclonal antibody. J Pharm Sci. 2014 Jul; 103(7):1979-1986. PMID: 24832730.
      View in: PubMed
    62. Mehta SB, Bee JS, Randolph TW, Carpenter JF. Partial unfolding of a monoclonal antibody: role of a single domain in driving protein aggregation. Biochemistry. 2014 May 27; 53(20):3367-77. PMID: 24804773.
      View in: PubMed
    63. Fradkin AH, Mozziconacci O, Sch?neich C, Carpenter JF, Randolph TW. UV photodegradation of murine growth hormone: chemical analysis and immunogenicity consequences. Eur J Pharm Biopharm. 2014 Jul; 87(2):395-402. PMID: 24758742.
      View in: PubMed
    64. Gerhardt A, Mcgraw NR, Schwartz DK, Bee JS, Carpenter JF, Randolph TW. Protein aggregation and particle formation in prefilled glass syringes. J Pharm Sci. 2014 Jun; 103(6):1601-12. PMID: 24729310.
      View in: PubMed
    65. Xu Y, Grobelny P, Von Allmen A, Knudson K, Pikal M, Carpenter JF, Randolph TW. Protein quantity on the air-solid interface determines degradation rates of human growth hormone in lyophilized samples. J Pharm Sci. 2014 May; 103(5):1356-66. PMID: 24623139.
      View in: PubMed
    66. Barnard JG, Kahn D, Cetlin D, Randolph TW, Carpenter JF. Investigations into the fouling mechanism of parvovirus filters during filtration of freeze-thawed mAb drug substance solutions. J Pharm Sci. 2014 Mar; 103(3):890-9. PMID: 24549732.
      View in: PubMed
    67. Basu P, Blake-Haskins AW, O'Berry KB, Randolph TW, Carpenter JF. Albinterferon a2b adsorption to silicone oil-water interfaces: effects on protein conformation, aggregation, and subvisible particle formation. J Pharm Sci. 2014 Feb; 103(2):427-36. PMID: 24382812.
      View in: PubMed
    68. Qi W, Zeng Y, Orgel S, Francon A, Kim JH, Randolph TW, Carpenter JF, Middaugh CR. Preformulation study of highly purified inactivated polio vaccine, serotype 3. J Pharm Sci. 2014 Jan; 103(1):140-51. PMID: 24282078.
      View in: PubMed
    69. Christie M, Torres RM, Kedl RM, Randolph TW, Carpenter JF. Recombinant murine growth hormone particles are more immunogenic with intravenous than subcutaneous administration. J Pharm Sci. 2014 Jan; 103(1):128-39. PMID: 25133276.
      View in: PubMed
    70. Shomali M, Freitag A, Engert J, Siedler M, Kaymakcalan Z, Winter G, Carpenter JF, Randolph TW. Antibody responses in mice to particles formed from adsorption of a murine monoclonal antibody onto glass microparticles. J Pharm Sci. 2014 Jan; 103(1):78-89. PMID: 24227137.
      View in: PubMed
    71. Liu L, Qi W, Schwartz DK, Randolph TW, Carpenter JF. The effects of excipients on protein aggregation during agitation: an interfacial shear rheology study. J Pharm Sci. 2013 Aug; 102(8):2460-70. PMID: 23712900.
      View in: PubMed
    72. Izutsu K, Yomota C, Okuda H, Kawanishi T, Randolph TW, Carpenter JF. Impact of heat treatment on miscibility of proteins and disaccharides in frozen solutions. Eur J Pharm Biopharm. 2013 Oct; 85(2):177-83. PMID: 23692695.
      View in: PubMed
    73. Hassett KJ, Cousins MC, Rabia LA, Chadwick CM, O'Hara JM, Nandi P, Brey RN, Mantis NJ, Carpenter JF, Randolph TW. Stabilization of a recombinant ricin toxin A subunit vaccine through lyophilization. Eur J Pharm Biopharm. 2013 Oct; 85(2):279-86. PMID: 23583494.
      View in: PubMed
    74. Payton NM, Wempe MF, Betker JL, Randolph TW, Anchordoquy TJ. Lyophilization of a triply unsaturated phospholipid: effects of trace metal contaminants. Eur J Pharm Biopharm. 2013 Oct; 85(2):306-13. PMID: 23567484.
      View in: PubMed
    75. Basu P, Krishnan S, Thirumangalathu R, Randolph TW, Carpenter JF. IgG1 aggregation and particle formation induced by silicone-water interfaces on siliconized borosilicate glass beads: a model for siliconized primary containers. J Pharm Sci. 2013 Mar; 102(3):852-65. PMID: 23280943.
      View in: PubMed
    76. Gerhardt A, Bonam K, Bee JS, Carpenter JF, Randolph TW. Ionic strength affects tertiary structure and aggregation propensity of a monoclonal antibody adsorbed to silicone oil-water interfaces. J Pharm Sci. 2013 Feb; 102(2):429-40. PMID: 23212809.
      View in: PubMed
    77. Chou DK, Krishnamurthy R, Manning MC, Randolph TW, Carpenter JF. Effects of solution conditions on methionine oxidation in albinterferon alfa-2b and the role of oxidation in its conformation and aggregation. J Pharm Sci. 2013 Feb; 102(2):660-73. PMID: 23203978.
      View in: PubMed
    78. Britt KA, Schwartz DK, Wurth C, Mahler HC, Carpenter JF, Randolph TW. Excipient effects on humanized monoclonal antibody interactions with silicone oil emulsions. J Pharm Sci. 2012 Dec; 101(12):4419-32. PMID: 22987313.
      View in: PubMed
    79. Chou DK, Krishnamurthy R, Manning MC, Randolph TW, Carpenter JF. Physical stability of albinterferon-a(2b) in aqueous solution: effects of conformational stability and colloidal stability on aggregation. J Pharm Sci. 2012 Aug; 101(8):2702-19. PMID: 22674119.
      View in: PubMed
    80. Liu L, Randolph TW, Carpenter JF. Particles shed from syringe filters and their effects on agitation-induced protein aggregation. J Pharm Sci. 2012 Aug; 101(8):2952-9. PMID: 22674153.
      View in: PubMed
    81. Cordes AA, Carpenter JF, Randolph TW. Accelerated stability studies of abatacept formulations: comparison of freeze-thawing- and agitation-induced stresses. J Pharm Sci. 2012 Jul; 101(7):2307-15. PMID: 22488299.
      View in: PubMed
    82. Cordes AA, Carpenter JF, Randolph TW. Selective domain stabilization as a strategy to reduce human serum albumin-human granulocyte colony stimulating factor aggregation rate. J Pharm Sci. 2012 Jun; 101(6):2009-16. PMID: 22422106.
      View in: PubMed
    83. Cordes AA, Platt CW, Carpenter JF, Randolph TW. Selective domain stabilization as a strategy to reduce fusion protein aggregation. J Pharm Sci. 2012 Apr; 101(4):1400-9. PMID: 22234888.
      View in: PubMed
    84. Randolph TW. The two faces of His-tag: immune response versus ease of protein purification. Biotechnol J. 2012 Jan; 7(1):18-9. PMID: 22213648.
      View in: PubMed
    85. Jiskoot W, Randolph TW, Volkin DB, Middaugh CR, Sch?neich C, Winter G, Friess W, Crommelin DJ, Carpenter JF. Protein instability and immunogenicity: roadblocks to clinical application of injectable protein delivery systems for sustained release. J Pharm Sci. 2012 Mar; 101(3):946-54. PMID: 22170395.
      View in: PubMed
    86. Van Beers MM, Gilli F, Schellekens H, Randolph TW, Jiskoot W. Immunogenicity of recombinant human interferon beta interacting with particles of glass, metal, and polystyrene. J Pharm Sci. 2012 Jan; 101(1):187-99. PMID: 21918983.
      View in: PubMed
    87. Fradkin AH, Carpenter JF, Randolph TW. Glass particles as an adjuvant: a model for adverse immunogenicity of therapeutic proteins. J Pharm Sci. 2011 Nov; 100(11):4953-64. PMID: 21721003.
      View in: PubMed
    88. Alford JR, Fowler AC, Wuttke DS, Kerwin BA, Latypov RF, Carpenter JF, Randolph TW. Effect of benzyl alcohol on recombinant human interleukin-1 receptor antagonist structure and hydrogen-deuterium exchange. J Pharm Sci. 2011 Oct; 100(10):4215-24. PMID: 21557223.
      View in: PubMed
    89. Ludwig DB, Webb JN, Fern?ndez C, Carpenter JF, Randolph TW. Quaternary conformational stability: the effect of reversible self-association on the fibrillation of two insulin analogs. Biotechnol Bioeng. 2011 Oct; 108(10):2359-70. PMID: 21520027.
      View in: PubMed
    90. Bee JS, Randolph TW, Carpenter JF, Bishop SM, Dimitrova MN. Effects of surfaces and leachables on the stability of biopharmaceuticals. J Pharm Sci. 2011 Oct; 100(10):4158-70. PMID: 21523787.
      View in: PubMed
    91. Ludwig DB, Trotter JT, Gabrielson JP, Carpenter JF, Randolph TW. Flow cytometry: a promising technique for the study of silicone oil-induced particulate formation in protein formulations. Anal Biochem. 2011 Mar 15; 410(2):191-9. PMID: 21146492.
      View in: PubMed
    92. Crisman RL, Randolph TW. Crystallization of recombinant human growth hormone at elevated pressures: pressure effects on PEG-induced volume exclusion interactions. Biotechnol Bioeng. 2010 Nov 01; 107(4):663-72. PMID: 20589675.
      View in: PubMed
    93. Bai S, Manning MC, Randolph TW, Carpenter JF. Aggregation of recombinant human botulinum protein antigen serotype C in varying solution conditions: implications of conformational stability for aggregation kinetics. J Pharm Sci. 2011 Mar; 100(3):836-48. PMID: 20862672.
      View in: PubMed
    94. Barnard JG, Singh S, Randolph TW, Carpenter JF. Subvisible particle counting provides a sensitive method of detecting and quantifying aggregation of monoclonal antibody caused by freeze-thawing: insights into the roles of particles in the protein aggregation pathway. J Pharm Sci. 2011 Feb; 100(2):492-503. PMID: 20803602.
      View in: PubMed
    95. Salinas BA, Sathish HA, Shah AU, Carpenter JF, Randolph TW. Buffer-dependent fragmentation of a humanized full-length monoclonal antibody. J Pharm Sci. 2010 Jul; 99(7):2962-74. PMID: 20091831.
      View in: PubMed
    96. Hoehne M, Samuel F, Dong A, Wurth C, Mahler HC, Carpenter JF, Randolph TW. Adsorption of monoclonal antibodies to glass microparticles. J Pharm Sci. 2011 Jan; 100(1):123-32. PMID: 20575075.
      View in: PubMed
    97. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G. Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: essential need to use orthogonal methods to assure the quality of therapeutic protein products. J Pharm Sci. 2010 May; 99(5):2200-8. PMID: 19918982.
      View in: PubMed
    98. Fradkin AH, Boand CS, Eisenberg SP, Rosendahl MS, Randolph TW. Recombinant murine growth hormone from E. coli inclusion bodies: expression, high-pressure solubilization and refolding, and characterization of activity and structure. Biotechnol Prog. 2010 May-Jun; 26(3):743-9. PMID: 20196161.
      View in: PubMed
    99. Ludwig DB, Carpenter JF, Hamel JB, Randolph TW. Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions. J Pharm Sci. 2010 Apr; 99(4):1721-33. PMID: 19894257.
      View in: PubMed
    100. Serno T, Carpenter JF, Randolph TW, Winter G. Inhibition of agitation-induced aggregation of an IgG-antibody by hydroxypropyl-beta-cyclodextrin. J Pharm Sci. 2010 Mar; 99(3):1193-206. PMID: 19774651.
      View in: PubMed
    101. Bee JS, Davis M, Freund E, Carpenter JF, Randolph TW. Aggregation of a monoclonal antibody induced by adsorption to stainless steel. Biotechnol Bioeng. 2010 Jan 01; 105(1):121-9. PMID: 19725039.
      View in: PubMed
    102. Salinas BA, Sathish HA, Bishop SM, Harn N, Carpenter JF, Randolph TW. Understanding and modulating opalescence and viscosity in a monoclonal antibody formulation. J Pharm Sci. 2010 Jan; 99(1):82-93. PMID: 19475558.
      View in: PubMed
    103. Fast JL, Cordes AA, Carpenter JF, Randolph TW. Physical instability of a therapeutic Fc fusion protein: domain contributions to conformational and colloidal stability. Biochemistry. 2009 Dec 15; 48(49):11724-36. PMID: 19899812.
      View in: PubMed
    104. Katayama DS, Carpenter JF, Menard KP, Manning MC, Randolph TW. Mixing properties of lyophilized protein systems: a spectroscopic and calorimetric study. J Pharm Sci. 2009 Sep; 98(9):2954-69. PMID: 18623211.
      View in: PubMed
    105. Fradkin AH, Carpenter JF, Randolph TW. Immunogenicity of aggregates of recombinant human growth hormone in mouse models. J Pharm Sci. 2009 Sep; 98(9):3247-64. PMID: 19569057.
      View in: PubMed
    106. Bee JS, Nelson SA, Freund E, Carpenter JF, Randolph TW. Precipitation of a monoclonal antibody by soluble tungsten. J Pharm Sci. 2009 Sep; 98(9):3290-301. PMID: 19230018.
      View in: PubMed
    107. Estey T, Vessely C, Randolph TW, Henderson I, Braun LJ, Nayar R, Carpenter JF. Evaluation of chemical degradation of a trivalent recombinant protein vaccine against botulinum neurotoxin by LysC peptide mapping and MALDI-TOF mass spectrometry. J Pharm Sci. 2009 Sep; 98(9):2994-3012. PMID: 18781606.
      View in: PubMed
    108. Bee JS, Chiu D, Sawicki S, Stevenson JL, Chatterjee K, Freund E, Carpenter JF, Randolph TW. Monoclonal antibody interactions with micro- and nanoparticles: adsorption, aggregation, and accelerated stress studies. J Pharm Sci. 2009 Sep; 98(9):3218-38. PMID: 19492408.
      View in: PubMed
    109. Vessely C, Estey T, Randolph TW, Henderson I, Cooper J, Nayar R, Braun LJ, Carpenter JF. Stability of a trivalent recombinant protein vaccine formulation against botulinum neurotoxin during storage in aqueous solution. J Pharm Sci. 2009 Sep; 98(9):2970-93. PMID: 18680175.
      View in: PubMed
    110. Thirumangalathu R, Krishnan S, Ricci MS, Brems DN, Randolph TW, Carpenter JF. Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution. J Pharm Sci. 2009 Sep; 98(9):3167-81. PMID: 19360857.
      View in: PubMed
    111. Bee JS, Stevenson JL, Mehta B, Svitel J, Pollastrini J, Platz R, Freund E, Carpenter JF, Randolph TW. Response of a concentrated monoclonal antibody formulation to high shear. Biotechnol Bioeng. 2009 Aug 01; 103(5):936-43. PMID: 19370772.
      View in: PubMed
    112. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G, Fan YX, Kirshner S, Verthelyi D, Kozlowski S, Clouse KA, Swann PG, Rosenberg A, Cherney B. Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality. J Pharm Sci. 2009 Apr; 98(4):1201-5. PMID: 18704929.
      View in: PubMed
    113. Crisman RL, Randolph TW. Refolding of proteins from inclusion bodies is favored by a diminished hydrophobic effect at elevated pressures. Biotechnol Bioeng. 2009 Feb 01; 102(2):483-92. PMID: 18781701.
      View in: PubMed
    114. Tyagi AK, Randolph TW, Dong A, Maloney KM, Hitscherich C, Carpenter JF. IgG particle formation during filling pump operation: a case study of heterogeneous nucleation on stainless steel nanoparticles. J Pharm Sci. 2009 Jan; 98(1):94-104. PMID: 18454482.
      View in: PubMed
    115. Gabrielson JP, Arthur KK, Kendrick BS, Randolph TW, Stoner MR. Common excipients impair detection of protein aggregates during sedimentation velocity analytical ultracentrifugation. J Pharm Sci. 2009 Jan; 98(1):50-62. PMID: 18425806.
      View in: PubMed
    116. Clausi AL, Morin A, Carpenter JF, Randolph TW. Influence of protein conformation and adjuvant aggregation on the effectiveness of aluminum hydroxide adjuvant in a model alkaline phosphatase vaccine. J Pharm Sci. 2009 Jan; 98(1):114-21. PMID: 18506831.
      View in: PubMed
    117. Clausi A, Cummiskey J, Merkley S, Carpenter JF, Braun LJ, Randolph TW. Influence of particle size and antigen binding on effectiveness of aluminum salt adjuvants in a model lysozyme vaccine. J Pharm Sci. 2008 Dec; 97(12):5252-62. PMID: 18398901.
      View in: PubMed
    118. Roy S, Henderson I, Nayar R, Randolph TW, Carpenter JF. Effect of pH on stability of recombinant botulinum serotype A vaccine in aqueous solution and during storage of freeze-dried formulations. J Pharm Sci. 2008 Dec; 97(12):5132-46. PMID: 18399536.
      View in: PubMed
    119. Alford JR, Kendrick BS, Carpenter JF, Randolph TW. High concentration formulations of recombinant human interleukin-1 receptor antagonist: II. Aggregation kinetics. J Pharm Sci. 2008 Aug; 97(8):3005-21. PMID: 17924426.
      View in: PubMed
    120. Alford JR, Kwok SC, Roberts JN, Wuttke DS, Kendrick BS, Carpenter JF, Randolph TW. High concentration formulations of recombinant human interleukin-1 receptor antagonist: I. Physical characterization. J Pharm Sci. 2008 Aug; 97(8):3035-50. PMID: 17973297.
      View in: PubMed
    121. Clausi AL, Merkley SA, Carpenter JF, Randolph TW. Inhibition of aggregation of aluminum hydroxide adjuvant during freezing and drying. J Pharm Sci. 2008 Jun; 97(6):2049-61. PMID: 17879291.
      View in: PubMed
    122. Kueltzo LA, Wang W, Randolph TW, Carpenter JF. Effects of solution conditions, processing parameters, and container materials on aggregation of a monoclonal antibody during freeze-thawing. J Pharm Sci. 2008 May; 97(5):1801-12. PMID: 17823949.
      View in: PubMed
    123. Alford JR, Kendrick BS, Carpenter JF, Randolph TW. Measurement of the second osmotic virial coefficient for protein solutions exhibiting monomer-dimer equilibrium. Anal Biochem. 2008 Jun 15; 377(2):128-33. PMID: 18395000.
      View in: PubMed
    124. Katayama DS, Carpenter JF, Manning MC, Randolph TW, Setlow P, Menard KP. Characterization of amorphous solids with weak glass transitions using high ramp rate differential scanning calorimetry. J Pharm Sci. 2008 Feb; 97(2):1013-24. PMID: 17724657.
      View in: PubMed
    125. Seefeldt MB, Crouch C, Kendrick B, Randolph TW. Specific volume and adiabatic compressibility measurements of native and aggregated recombinant human interleukin-1 receptor antagonist: density differences enable pressure-modulated refolding. Biotechnol Bioeng. 2007 Oct 01; 98(2):476-85. PMID: 17335058.
      View in: PubMed
    126. Vessely C, Estey T, Randolph TW, Henderson I, Nayar R, Carpenter JF. Effects of solution conditions and surface chemistry on the adsorption of three recombinant botulinum neurotoxin antigens to aluminum salt adjuvants. J Pharm Sci. 2007 Sep; 96(9):2375-89. PMID: 17518359.
      View in: PubMed
    127. Downey CD, Crisman RL, Randolph TW, Pardi A. Influence of hydrostatic pressure and cosolutes on RNA tertiary structure. J Am Chem Soc. 2007 Aug 01; 129(30):9290-1. PMID: 17616193.
      View in: PubMed
    128. Thirumangalathu R, Krishnan S, Bondarenko P, Speed-Ricci M, Randolph TW, Carpenter JF, Brems DN. Oxidation of methionine residues in recombinant human interleukin-1 receptor antagonist: implications of conformational stability on protein oxidation kinetics. Biochemistry. 2007 May 29; 46(21):6213-24. PMID: 17480058.
      View in: PubMed
    129. Gabrielson JP, Brader ML, Pekar AH, Mathis KB, Winter G, Carpenter JF, Randolph TW. Quantitation of aggregate levels in a recombinant humanized monoclonal antibody formulation by size-exclusion chromatography, asymmetrical flow field flow fractionation, and sedimentation velocity. J Pharm Sci. 2007 Feb; 96(2):268-79. PMID: 17080424.
      View in: PubMed
    130. Gabrielson JP, Randolph TW, Kendrick BS, Stoner MR. Sedimentation velocity analytical ultracentrifugation and SEDFIT/c(s): limits of quantitation for a monoclonal antibody system. Anal Biochem. 2007 Feb 01; 361(1):24-30. PMID: 17181992.
      View in: PubMed
    131. Ng KY, Zhou H, Zhang YL, Hybertson B, Randolph T, Christians U. Quantification of isoniazid and acetylisoniazid in rat plasma and alveolar macrophages by liquid chromatography-tandem mass spectrometry with on-line extraction. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Mar 01; 847(2):188-98. PMID: 17070115.
      View in: PubMed
    132. Thirumangalathu R, Krishnan S, Brems DN, Randolph TW, Carpenter JF. Effects of pH, temperature, and sucrose on benzyl alcohol-induced aggregation of recombinant human granulocyte colony stimulating factor. J Pharm Sci. 2006 Jul; 95(7):1480-97. PMID: 16729274.
      View in: PubMed
    133. Randolph TW, Yasui Y. Multiscale processing of mass spectrometry data. Biometrics. 2006 Jun; 62(2):589-97. PMID: 16918924.
      View in: PubMed
    134. Roy S, Katayama D, Dong A, Kerwin BA, Randolph TW, Carpenter JF. Temperature dependence of benzyl alcohol- and 8-anilinonaphthalene-1-sulfonate-induced aggregation of recombinant human interleukin-1 receptor antagonist. Biochemistry. 2006 Mar 28; 45(12):3898-911. PMID: 16548517.
      View in: PubMed
    135. Kim YS, Randolph TW, Seefeldt MB, Carpenter JF. High-pressure studies on protein aggregates and amyloid fibrils. Methods Enzymol. 2006; 413:237-53. PMID: 17046400.
      View in: PubMed
    136. Stoner MR, Dale DA, Gualfetti PJ, Becker T, Randolph TW. Surfactant-induced unfolding of cellulase: kinetic studies. Biotechnol Prog. 2006 Jan-Feb; 22(1):225-32. PMID: 16454514.
      View in: PubMed
    137. Lee SH, Carpenter JF, Chang BS, Randolph TW, Kim YS. Effects of solutes on solubilization and refolding of proteins from inclusion bodies with high hydrostatic pressure. Protein Sci. 2006 Feb; 15(2):304-13. PMID: 16385003.
      View in: PubMed
    138. Jarmer DJ, Lengsfeld CS, Anseth KS, Randolph TW. Supercritical fluid crystallization of griseofulvin: crystal habit modification with a selective growth inhibitor. J Pharm Sci. 2005 Dec; 94(12):2688-702. PMID: 16258994.
      View in: PubMed
    139. Chi EY, Kendrick BS, Carpenter JF, Randolph TW. Population balance modeling of aggregation kinetics of recombinant human interleukin-1 receptor antagonist. J Pharm Sci. 2005 Dec; 94(12):2735-48. PMID: 16258998.
      View in: PubMed
    140. Stoner MR, Dale DA, Gualfetti PJ, Becker T, Randolph TW. Ca2+-surfactant interactions affect enzyme stability in detergent solutions. Biotechnol Prog. 2005 Nov-Dec; 21(6):1716-23. PMID: 16321056.
      View in: PubMed
    141. Zhou H, Zhang Y, Biggs DL, Manning MC, Randolph TW, Christians U, Hybertson BM, Ng KY. Microparticle-based lung delivery of INH decreases INH metabolism and targets alveolar macrophages. J Control Release. 2005 Oct 03; 107(2):288-99. PMID: 16009444.
      View in: PubMed
    142. Seefeldt MB, Kim YS, Tolley KP, Seely J, Carpenter JF, Randolph TW. High-pressure studies of aggregation of recombinant human interleukin-1 receptor antagonist: thermodynamics, kinetics, and application to accelerated formulation studies. Protein Sci. 2005 Sep; 14(9):2258-66. PMID: 16081653.
      View in: PubMed
    143. Chou DK, Krishnamurthy R, Randolph TW, Carpenter JF, Manning MC. Effects of Tween 20 and Tween 80 on the stability of Albutropin during agitation. J Pharm Sci. 2005 Jun; 94(6):1368-81. PMID: 15858848.
      View in: PubMed
    144. Chi EY, Weickmann J, Carpenter JF, Manning MC, Randolph TW. Heterogeneous nucleation-controlled particulate formation of recombinant human platelet-activating factor acetylhydrolase in pharmaceutical formulation. J Pharm Sci. 2005 Feb; 94(2):256-74. PMID: 15570600.
      View in: PubMed
    145. Roy S, Jung R, Kerwin BA, Randolph TW, Carpenter JF. Effects of benzyl alcohol on aggregation of recombinant human interleukin-1-receptor antagonist in reconstituted lyophilized formulations. J Pharm Sci. 2005 Feb; 94(2):382-96. PMID: 15614819.
      View in: PubMed
    146. Zhang Y, Roy S, Jones LS, Krishnan S, Kerwin BA, Chang BS, Manning MC, Randolph TW, Carpenter JF. Mechanism for benzyl alcohol-induced aggregation of recombinant human interleukin-1 receptor antagonist in aqueous solution. J Pharm Sci. 2004 Dec; 93(12):3076-89. PMID: 15514986.
      View in: PubMed
    147. Patel MM, Zeles MG, Manning MC, Randolph TW, Anchordoquy TJ. Degradation kinetics of high molecular weight poly(L-lactide) microspheres and release mechanism of lipid:DNA complexes. J Pharm Sci. 2004 Oct; 93(10):2573-84. PMID: 15349967.
      View in: PubMed
    148. Seefeldt MB, Ouyang J, Froland WA, Carpenter JF, Randolph TW. High-pressure refolding of bikunin: efficacy and thermodynamics. Protein Sci. 2004 Oct; 13(10):2639-50. PMID: 15388859.
      View in: PubMed
    149. Stoner MR, Fischer N, Nixon L, Buckel S, Benke M, Austin F, Randolph TW, Kendrick BS. Protein-solute interactions affect the outcome of ultrafiltration/diafiltration operations. J Pharm Sci. 2004 Sep; 93(9):2332-42. PMID: 15295793.
      View in: PubMed
    150. Jarmer DJ, Lengsfeld CS, Randolph TW. Nucleation and growth rates of poly(L-lactic acid) microparticles during precipitation with a compressed-fluid antisolvent. Langmuir. 2004 Aug 17; 20(17):7254-64. PMID: 15301513.
      View in: PubMed
    151. Garzon-Rodriguez W, Koval RL, Chongprasert S, Krishnan S, Randolph TW, Warne NW, Carpenter JF. Optimizing storage stability of lyophilized recombinant human interleukin-11 with disaccharide/hydroxyethyl starch mixtures. J Pharm Sci. 2004 Mar; 93(3):684-96. PMID: 14762907.
      View in: PubMed
    152. Biggs DL, Lengsfeld CS, Hybertson BM, Ng KY, Manning MC, Randolph TW. In vitro and in vivo evaluation of the effects of PLA microparticle crystallinity on cellular response. J Control Release. 2003 Sep 19; 92(1-2):147-61. PMID: 14499193.
      View in: PubMed
    153. Chi EY, Krishnan S, Randolph TW, Carpenter JF. Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation. Pharm Res. 2003 Sep; 20(9):1325-36. PMID: 14567625.
      View in: PubMed
    154. Kim YS, Jones LS, Dong A, Kendrick BS, Chang BS, Manning MC, Randolph TW, Carpenter JF. Effects of sucrose on conformational equilibria and fluctuations within the native-state ensemble of proteins. Protein Sci. 2003 Jun; 12(6):1252-61. PMID: 12761396.
      View in: PubMed
    155. Chi EY, Krishnan S, Kendrick BS, Chang BS, Carpenter JF, Randolph TW. Roles of conformational stability and colloidal stability in the aggregation of recombinant human granulocyte colony-stimulating factor. Protein Sci. 2003 May; 12(5):903-13. PMID: 12717013.
      View in: PubMed
    156. Webb SD, Cleland JL, Carpenter JF, Randolph TW. Effects of annealing lyophilized and spray-lyophilized formulations of recombinant human interferon-gamma. J Pharm Sci. 2003 Apr; 92(4):715-29. PMID: 12661058.
      View in: PubMed
    157. Krishnan S, Chi EY, Wood SJ, Kendrick BS, Li C, Garzon-Rodriguez W, Wypych J, Randolph TW, Narhi LO, Biere AL, Citron M, Carpenter JF. Oxidative dimer formation is the critical rate-limiting step for Parkinson's disease alpha-synuclein fibrillogenesis. Biochemistry. 2003 Jan 28; 42(3):829-37. PMID: 12534296.
      View in: PubMed
    158. Kim YS, Randolph TW, Manning MC, Stevens FJ, Carpenter JF. Congo red populates partially unfolded states of an amyloidogenic protein to enhance aggregation and amyloid fibril formation. J Biol Chem. 2003 Mar 21; 278(12):10842-50. PMID: 12529361.
      View in: PubMed
    159. Stay MS, Xu J, Randolph TW, Barocas VH. Computer simulation of convective and diffusive transport of controlled-release drugs in the vitreous humor. Pharm Res. 2003 Jan; 20(1):96-102. PMID: 12608542.
      View in: PubMed
    160. Lengsfeld CS, Manning MC, Randolph TW. Encapsulating DNA within biodegradable polymeric microparticles. Curr Pharm Biotechnol. 2002 Sep; 3(3):227-35. PMID: 12164479.
      View in: PubMed
    161. Zhou H, Lengsfeld C, Claffey DJ, Ruth JA, Hybertson B, Randolph TW, Ng KY, Manning MC. Hydrophobic ion pairing of isoniazid using a prodrug approach. J Pharm Sci. 2002 Jun; 91(6):1502-11. PMID: 12115849.
      View in: PubMed
    162. Webb SD, Golledge SL, Cleland JL, Carpenter JF, Randolph TW. Surface adsorption of recombinant human interferon-gamma in lyophilized and spray-lyophilized formulations. J Pharm Sci. 2002 Jun; 91(6):1474-87. PMID: 12115847.
      View in: PubMed
    163. Kim YS, Randolph TW, Stevens FJ, Carpenter JF. Kinetics and energetics of assembly, nucleation, and growth of aggregates and fibrils for an amyloidogenic protein. Insights into transition states from pressure, temperature, and co-solute studies. J Biol Chem. 2002 Jul 26; 277(30):27240-6. PMID: 12023282.
      View in: PubMed
    164. Krishnan S, Chi EY, Webb JN, Chang BS, Shan D, Goldenberg M, Manning MC, Randolph TW, Carpenter JF. Aggregation of granulocyte colony stimulating factor under physiological conditions: characterization and thermodynamic inhibition. Biochemistry. 2002 May 21; 41(20):6422-31. PMID: 12009905.
      View in: PubMed
    165. Carpenter JF, Manning MC, Randolph TW. Long-term storage of proteins. Curr Protoc Protein Sci. 2002 May; Chapter 4:Unit 4.6. PMID: 18429236.
      View in: PubMed
    166. Randolph TW, Seefeldt M, Carpenter JF. High hydrostatic pressure as a tool to study protein aggregation and amyloidosis. Biochim Biophys Acta. 2002 Mar 25; 1595(1-2):224-34. PMID: 11983398.
      View in: PubMed
    167. Randolph TW, Jones LS. Surfactant-protein interactions. Pharm Biotechnol. 2002; 13:159-75. PMID: 11987751.
      View in: PubMed
    168. Carpenter JF, Chang BS, Garzon-Rodriguez W, Randolph TW. Rational design of stable lyophilized protein formulations: theory and practice. Pharm Biotechnol. 2002; 13:109-33. PMID: 11987749.
      View in: PubMed
    169. Webb SD, Koval CA, Randolph CM, Randolph TW. Electrochemical determination of dissolution rates of lyophilized pharmaceutical formulations. Anal Chem. 2001 Nov 01; 73(21):5296-301. PMID: 11721932.
      View in: PubMed
    170. Jones LS, Randolph TW, Kohnert U, Papadimitriou A, Winter G, Hagmann ML, Manning MC, Carpenter JF. The effects of Tween 20 and sucrose on the stability of anti-L-selectin during lyophilization and reconstitution. J Pharm Sci. 2001 Oct; 90(10):1466-77. PMID: 11745706.
      View in: PubMed
    171. Searles JA, Carpenter JF, Randolph TW. Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine T(g)' in pharmaceutical lyophilization. J Pharm Sci. 2001 Jul; 90(7):872-87. PMID: 11458336.
      View in: PubMed
    172. Searles JA, Carpenter JF, Randolph TW. The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf. J Pharm Sci. 2001 Jul; 90(7):860-71. PMID: 11458335.
      View in: PubMed
    173. Anchordoquy TJ, Izutsu KI, Randolph TW, Carpenter JF. Maintenance of quaternary structure in the frozen state stabilizes lactate dehydrogenase during freeze-drying. Arch Biochem Biophys. 2001 Jun 01; 390(1):35-41. PMID: 11368512.
      View in: PubMed
    174. Kim YS, Cape SP, Chi E, Raffen R, Wilkins-Stevens P, Stevens FJ, Manning MC, Randolph TW, Solomon A, Carpenter JF. Counteracting effects of renal solutes on amyloid fibril formation by immunoglobulin light chains. J Biol Chem. 2001 Jan 12; 276(2):1626-33. PMID: 11050093.
      View in: PubMed
    175. DePaz RA, Barnett CC, Dale DA, Carpenter JF, Gaertner AL, Randolph TW. The excluding effects of sucrose on a protein chemical degradation pathway: methionine oxidation in subtilisin. Arch Biochem Biophys. 2000 Dec 01; 384(1):123-32. PMID: 11147823.
      View in: PubMed
    176. Yang TH, Cleland JL, Lam X, Meyer JD, Jones LS, Randolph TW, Manning MC, Carpenter JF. Effect of zinc binding and precipitation on structures of recombinant human growth hormone and nerve growth factor. J Pharm Sci. 2000 Nov; 89(11):1480-5. PMID: 11015692.
      View in: PubMed
    177. Dong A, Randolph TW, Carpenter JF. Entrapping intermediates of thermal aggregation in alpha-helical proteins with low concentration of guanidine hydrochloride. J Biol Chem. 2000 Sep 08; 275(36):27689-93. PMID: 10871628.
      View in: PubMed
    178. Webb JN, Carpenter JF, Randolph TW. Stability of subtilisin and lysozyme under high hydrostatic pressure. Biotechnol Prog. 2000 Jul-Aug; 16(4):630-6. PMID: 10933838.
      View in: PubMed
    179. Xu J, Heys JJ, Barocas VH, Randolph TW. Permeability and diffusion in vitreous humor: implications for drug delivery. Pharm Res. 2000 Jun; 17(6):664-9. PMID: 10955838.
      View in: PubMed
    180. Allison SD, Manning MC, Randolph TW, Middleton K, Davis A, Carpenter JF. Optimization of storage stability of lyophilized actin using combinations of disaccharides and dextran. J Pharm Sci. 2000 Feb; 89(2):199-214. PMID: 10688749.
      View in: PubMed
    181. Kim Y, Wall JS, Meyer J, Murphy C, Randolph TW, Manning MC, Solomon A, Carpenter JF. Thermodynamic modulation of light chain amyloid fibril formation. J Biol Chem. 2000 Jan 21; 275(3):1570-4. PMID: 10636846.
      View in: PubMed
    182. St John RJ, Carpenter JF, Randolph TW. High pressure fosters protein refolding from aggregates at high concentrations. Proc Natl Acad Sci U S A. 1999 Nov 09; 96(23):13029-33. PMID: 10557267.
      View in: PubMed
    183. Jones LS, Cipolla D, Liu J, Shire SJ, Randolph TW. Investigation of protein-surfactant interactions by analytical ultracentrifugation and electron paramagnetic resonance: the use of recombinant human tissue factor as an example. Pharm Res. 1999 Jun; 16(6):808-12. PMID: 10397598.
      View in: PubMed
    184. Allison SD, Chang B, Randolph TW, Carpenter JF. Hydrogen bonding between sugar and protein is responsible for inhibition of dehydration-induced protein unfolding. Arch Biochem Biophys. 1999 May 15; 365(2):289-98. PMID: 10328824.
      View in: PubMed
    185. Heller MC, Carpenter JF, Randolph TW. Protein formulation and lyophilization cycle design: prevention of damage due to freeze-concentration induced phase separation. Biotechnol Bioeng. 1999 Apr 20; 63(2):166-74. PMID: 10099593.
      View in: PubMed
    186. Heller MC, Carpenter JF, Randolph TW. Application of a thermodynamic model to the prediction of phase separations in freeze-concentrated formulations for protein lyophilization. Arch Biochem Biophys. 1999 Mar 15; 363(2):191-201. PMID: 10068440.
      View in: PubMed
    187. Kreilgaard L, Frokjaer S, Flink JM, Randolph TW, Carpenter JF. Effects of additives on the stability of Humicola lanuginosa lipase during freeze-drying and storage in the dried solid. J Pharm Sci. 1999 Mar; 88(3):281-90. PMID: 10052984.
      View in: PubMed
    188. Carpenter JF, Kendrick BS, Chang BS, Manning MC, Randolph TW. Inhibition of stress-induced aggregation of protein therapeutics. Methods Enzymol. 1999; 309:236-55. PMID: 10507028.
      View in: PubMed
    189. Heller MC, Carpenter JF, Randolph TW. Conformational stability of lyophilized PEGylated proteins in a phase-separating system. J Pharm Sci. 1999 Jan; 88(1):58-64. PMID: 9874703.
      View in: PubMed
    190. Kreilgaard L, Jones LS, Randolph TW, Frokjaer S, Flink JM, Manning MC, Carpenter JF. Effect of Tween 20 on freeze-thawing- and agitation-induced aggregation of recombinant human factor XIII. J Pharm Sci. 1998 Dec; 87(12):1597-603. PMID: 10189273.
      View in: PubMed
    191. Bam NB, Cleland JL, Yang J, Manning MC, Carpenter JF, Kelley RF, Randolph TW. Tween protects recombinant human growth hormone against agitation-induced damage via hydrophobic interactions. J Pharm Sci. 1998 Dec; 87(12):1554-9. PMID: 10189266.
      View in: PubMed
    192. Kreilgaard L, Frokjaer S, Flink JM, Randolph TW, Carpenter JF. Effects of additives on the stability of recombinant human factor XIII during freeze-drying and storage in the dried solid. Arch Biochem Biophys. 1998 Dec 01; 360(1):121-34. PMID: 9826437.
      View in: PubMed
    193. Kendrick BS, Carpenter JF, Cleland JL, Randolph TW. A transient expansion of the native state precedes aggregation of recombinant human interferon-gamma. Proc Natl Acad Sci U S A. 1998 Nov 24; 95(24):14142-6. PMID: 9826667.
      View in: PubMed
    194. Allison SD, Randolph TW, Manning MC, Middleton K, Davis A, Carpenter JF. Effects of drying methods and additives on structure and function of actin: mechanisms of dehydration-induced damage and its inhibition. Arch Biochem Biophys. 1998 Oct 01; 358(1):171-81. PMID: 9750178.
      View in: PubMed
    195. Kerwin BA, Heller MC, Levin SH, Randolph TW. Effects of Tween 80 and sucrose on acute short-term stability and long-term storage at -20 degrees C of a recombinant hemoglobin. J Pharm Sci. 1998 Sep; 87(9):1062-8. PMID: 9724555.
      View in: PubMed
    196. Meyer JD, Falk RF, Kelly RM, Shively JE, Withrow SJ, Dernell WS, Kroll DJ, Randolph TW, Manning MC. Preparation and in vitro characterization of gentamycin-impregnated biodegradable beads suitable for treatment of osteomyelitis. J Pharm Sci. 1998 Sep; 87(9):1149-54. PMID: 9724569.
      View in: PubMed
    197. Kendrick BS, Cleland JL, Lam X, Nguyen T, Randolph TW, Manning MC, Carpenter JF. Aggregation of recombinant human interferon gamma: kinetics and structural transitions. J Pharm Sci. 1998 Sep; 87(9):1069-76. PMID: 9724556.
      View in: PubMed
    198. Falk RF, Randolph TW. Process variable implications for residual solvent removal and polymer morphology in the formation of gentamycin-loaded poly (L-lactide) microparticles. Pharm Res. 1998 Aug; 15(8):1233-7. PMID: 9706054.
      View in: PubMed
    199. Randolph TW. Phase separation of excipients during lyophilization: effects on protein stability. J Pharm Sci. 1997 Nov; 86(11):1198-203. PMID: 9383725.
      View in: PubMed
    200. Kendrick BS, Chang BS, Arakawa T, Peterson B, Randolph TW, Manning MC, Carpenter JF. Preferential exclusion of sucrose from recombinant interleukin-1 receptor antagonist: role in restricted conformational mobility and compaction of native state. Proc Natl Acad Sci U S A. 1997 Oct 28; 94(22):11917-22. PMID: 9342337.
      View in: PubMed
    201. Heller MC, Carpenter JF, Randolph TW. Manipulation of lyophilization-induced phase separation: implications for pharmaceutical proteins. Biotechnol Prog. 1997 Sep-Oct; 13(5):590-6. PMID: 9336978.
      View in: PubMed
    202. Carpenter JF, Pikal MJ, Chang BS, Randolph TW. Rational design of stable lyophilized protein formulations: some practical advice. Pharm Res. 1997 Aug; 14(8):969-75. PMID: 9279875.
      View in: PubMed
    203. Heller MC, Carpenter JF, Randolph TW. Effects of phase separating systems on lyophilized hemoglobin. J Pharm Sci. 1996 Dec; 85(12):1358-62. PMID: 8961153.
      View in: PubMed
    204. Bam NB, Cleland JL, Randolph TW. Molten globule intermediate of recombinant human growth hormone: stabilization with surfactants. Biotechnol Prog. 1996 Nov-Dec; 12(6):801-9. PMID: 8983207.
      View in: PubMed
    205. Izutsu K, Yoshioka S, Kojima S, Randolph TW, Carpenter JF. Effects of sugars and polymers on crystallization of poly(ethylene glycol) in frozen solutions: phase separation between incompatible polymers. Pharm Res. 1996 Sep; 13(9):1393-400. PMID: 8893281.
      View in: PubMed
    206. Bam NB, Randolph TW, Cleland JL. Stability of protein formulations: investigation of surfactant effects by a novel EPR spectroscopic technique. Pharm Res. 1995 Jan; 12(1):2-11. PMID: 7724484.
      View in: PubMed
    207. Randolph TW, Randolph AD, Mebes M, Yeung S. Sub-micrometer-sized biodegradable particles of poly(L-lactic acid) via the gas antisolvent spray precipitation process. Biotechnol Prog. 1993 Jul-Aug; 9(4):429-35. PMID: 7763910.
      View in: PubMed
    208. Cleland JL, Randolph TW. Mechanism of polyethylene glycol interaction with the molten globule folding intermediate of bovine carbonic anhydrase B. J Biol Chem. 1992 Feb 15; 267(5):3147-53. PMID: 1310682.
      View in: PubMed
    209. Randolph TW, Marison IW, Martens DE, von Stockar U. Calorimetric control of fed-batch fermentations. Biotechnol Bioeng. 1990 Oct 05; 36(7):678-84. PMID: 18597259.
      View in: PubMed
    210. Clark DS, Skerker PS, Randolph TW, Blanch HW, Prausnitz JM. Conformational analyses of enzymes and substrates in processing environments. Ann N Y Acad Sci. 1988; 542:16-29. PMID: 2852476.
      View in: PubMed
    Randolph's Networks
    Click the "See All" links for more information and interactive visualizations!
    Concepts Expand Description
    See all (504) concept(s)
    _
    Co-Authors Expand Description
    See all (14) people
    _
    Similar People Expand Description
    See all (60) people
    _
    Same Department Expand Description
    Search Department

    Copyright © 2025 The Regents of the University of Colorado, a body corporate. All rights reserved. (Harvard PROFILES RNS software version: 2.11.1)