Theodore W. Randolph - Publications

Affiliations: 
1993- Chemical Engineering University of Colorado, Boulder, Boulder, CO, United States 
Area:
Pharmaceutical Chemistry, Physical Chemistry
Website:
https://www.colorado.edu/chbe/theodore-w-randolph

205 high-probability publications. We are testing a new system for linking publications to authors. You can help! If you notice any inaccuracies, please sign in and mark papers as correct or incorrect matches. If you identify any major omissions or other inaccuracies in the publication list, please let us know.

Year Citation  Score
2020 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. Journal of Pharmaceutical Sciences. PMID 32931778 DOI: 10.1016/J.Xphs.2020.09.011  0.344
2020 Daniels AL, Calderon CP, Randolph TW. Machine Learning & Statistical Analyses for Extracting and Characterizing "Fingerprints" of Antibody Aggregation at Container Interfaces from Flow Microscopy Images. Biotechnology and Bioengineering. PMID 32667683 DOI: 10.1002/Bit.27501  0.319
2020 Movafaghi S, Wu H, Urdániz IMF, Bull DS, Kelly MD, Randolph TW, Goodwin AP. The Effect of Container Surface Passivation on Aggregation of Intravenous Immunoglobulin Induced by Mechanical Shock. Biotechnology Journal. e2000096. PMID 32437086 DOI: 10.1002/Biot.202000096  0.395
2020 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. Journal of Pharmaceutical Sciences. PMID 32004539 DOI: 10.1016/J.Xphs.2020.01.023  0.39
2020 Her C, Tanenbaum L, Bandi S, Randolph T, Thirumangalathu R, Mallela K, Carpenter J, Elias Y. Effects of tubing type, operating parameters and surfactants on particle formation during peristaltic filling pump processing of a monoclonal antibody formulation. Journal of Pharmaceutical Sciences. PMID 31954724 DOI: 10.1016/J.Xphs.2020.01.009  0.353
2019 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 following application of mechanical shock. Journal of Pharmaceutical Sciences. PMID 31758950 DOI: 10.1016/J.Xphs.2019.11.015  0.712
2019 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. Journal of Pharmaceutical Sciences. PMID 31229435 DOI: 10.1016/J.Xphs.2019.06.015  0.413
2019 Snell JR, Kumar NSK, Suryanarayanan R, Randolph TW. Nanobubbles in Reconstituted Lyophilized Formulations: Interaction with Proteins and Mechanism of Formation. Journal of Pharmaceutical Sciences. PMID 31095959 DOI: 10.1016/J.Xphs.2019.05.005  0.396
2019 Wu H, Randolph TW. Rapid Quantification of Protein Particles in High-Concentration Antibody Formulations. Journal of Pharmaceutical Sciences. 108: 1110-1116. PMID 30773198 DOI: 10.1016/J.Xphs.2018.10.021  0.379
2019 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. Journal of Pharmaceutical Sciences. PMID 30735687 DOI: 10.1016/J.Xphs.2019.01.029  0.301
2018 Sorret LL, Monticello CR, DeWinter MA, Schwartz DK, Randolph TW. Steric repulsion forces contributed by PEGylation of interleukin-1 receptor antagonist (rhIL-1ra) reduce gelation and aggregation at the silicone oil-water interface. Journal of Pharmaceutical Sciences. PMID 30395835 DOI: 10.1016/J.Xphs.2018.10.045  0.31
2018 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. Journal of Pharmaceutical Sciences. PMID 29709487 DOI: 10.1016/J.Xphs.2018.04.019  0.352
2018 Nejadnik MR, Randolph TW, Volkin DB, Schöneich C, Carpenter JF, Crommelin DJA, Jiskoot W. Post-production handling and administration of protein pharmaceuticals and potential instability issues. Journal of Pharmaceutical Sciences. PMID 29665382 DOI: 10.1016/J.Xphs.2018.04.005  0.321
2018 Pardeshi NN, Zhou C, Randolph TW, Carpenter JF. Protein nanoparticles promote microparticle formation in intravenous immunoglobulin solutions during freeze-thawing and agitation stresses. Journal of Pharmaceutical Sciences. PMID 29601840 DOI: 10.1016/J.Xphs.2018.03.016  0.334
2018 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 Science : a Publication of the Protein Society. PMID 29388282 DOI: 10.1002/Pro.3382  0.387
2017 Calderon CP, Daniels AL, Randolph TW. Deep Convolutional Neural Network Analysis of Flow Imaging Microscopy Data to Classify Subvisible Particles in Protein Formulations. Journal of Pharmaceutical Sciences. PMID 29269269 DOI: 10.1016/J.Xphs.2017.12.008  0.311
2017 Maddux NR, Daniels AL, Randolph TW. Micro-flow imaging analyses reflect mechanisms of aggregate formation: Comparing protein particle data sets using the Kullback-Leibler divergence. Journal of Pharmaceutical Sciences. PMID 28159641 DOI: 10.1016/J.Xphs.2017.01.030  0.339
2017 Latshaw DC, Randolph TW, Hall CK. Aggregation of amphipathic peptides at an aqueous–organic interface using coarse-grained simulations Molecular Simulation. 43: 1448-1458. DOI: 10.1080/08927022.2017.1319058  0.317
2016 Sorret LL, DeWinter MA, Schwartz DK, Randolph TW. Challenges in Predicting Protein-Protein Interactions from Measurements of Molecular Diffusivity. Biophysical Journal. 111: 1831-1842. PMID 27806265 DOI: 10.1016/J.Bpj.2016.09.018  0.362
2016 Snell JR, Zhou C, Carpenter JF, Randolph TW. Particle Formation and Aggregation of a Therapeutic Protein in Nanobubble Suspensions. Journal of Pharmaceutical Sciences. PMID 27488901 DOI: 10.1016/J.Xphs.2016.06.020  0.374
2016 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. Journal of Pharmaceutical Sciences. PMID 27422087 DOI: 10.1016/J.Xphs.2016.06.010  0.362
2016 Zhou C, Qi W, Lewis EN, Randolph TW, Carpenter JF. Reduced Subvisible Particle Formation in Lyophilized Intravenous Immunoglobulin Formulations Containing Polysorbate 20. Journal of Pharmaceutical Sciences. PMID 27290624 DOI: 10.1016/J.Xphs.2016.05.013  0.412
2016 Zhou C, Cleland D, Snell J, Qi W, Randolph TW, Carpenter JF. Formation of Stable Nanobubbles on Reconstituting Lyophilized Formulations Containing Trehalose. Journal of Pharmaceutical Sciences. PMID 27287517 DOI: 10.1016/J.Xphs.2016.04.035  0.362
2016 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. Journal of Pharmaceutical Sciences. PMID 27044944 DOI: 10.1016/J.Xphs.2016.02.031  0.329
2016 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. Journal of Pharmaceutical Sciences. PMID 27020987 DOI: 10.1016/J.Xphs.2016.02.019  0.304
2015 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. Journal of Pharmaceutical Sciences. PMID 26413998 DOI: 10.1002/Jps.24654  0.411
2015 Christie M, Peritt D, Torres RM, Randolph TW, Carpenter JF. The Role of Protein Excipient in Driving Antibody Responses to Erythropoietin. Journal of Pharmaceutical Sciences. PMID 26375484 DOI: 10.1002/Jps.24639  0.363
2015 McUmber AC, Randolph TW, Schwartz DK. Electrostatic Interactions Influence Protein Adsorption (but Not Desorption) at the Silica-Aqueous Interface. The Journal of Physical Chemistry Letters. 6: 2583-7. PMID 26266737 DOI: 10.1021/Acs.Jpclett.5B00933  0.304
2015 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. Journal of Pharmaceutical Sciences. 104: 3681-90. PMID 26190624 DOI: 10.1002/Jps.24573  0.303
2015 Hassett KJ, Meinerz NM, Semmelmann F, Cousins MC, Garcea RL, Randolph TW. Development of a highly thermostable, adjuvanted human papillomavirus vaccine. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft FüR Pharmazeutische Verfahrenstechnik E.V. 94: 220-8. PMID 25998700 DOI: 10.1016/J.Ejpb.2015.05.009  0.761
2015 McUmber AC, Larson NR, Randolph TW, Schwartz DK. Molecular trajectories provide signatures of protein clustering and crowding at the oil/water interface. Langmuir : the Acs Journal of Surfaces and Colloids. 31: 5882-90. PMID 25950404 DOI: 10.1021/Acs.Langmuir.5B00984  0.344
2015 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. Journal of Pharmaceutical Sciences. 104: 1601-9. PMID 25740412 DOI: 10.1002/Jps.24387  0.307
2015 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. Journal of Pharmaceutical Sciences. 104: 1610-21. PMID 25737325 DOI: 10.1002/Jps.24413  0.697
2015 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. Journal of Pharmaceutical Sciences. 104: 1282-90. PMID 25639229 DOI: 10.1002/Jps.24358  0.739
2015 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. Journal of Pharmaceutical Sciences. 104: 627-39. PMID 25581103 DOI: 10.1002/Jps.24295  0.77
2015 Randolph TW, Schiltz E, Sederstrom D, Steinmann D, Mozziconacci O, Schöneich C, Freund E, Ricci MS, Carpenter JF, Lengsfeld CS. Do not drop: mechanical shock in vials causes cavitation, protein aggregation, and particle formation. Journal of Pharmaceutical Sciences. 104: 602-11. PMID 25418950 DOI: 10.1002/Jps.24259  0.725
2015 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. Pharmaceutical Research. 32: 430-44. PMID 25123991 DOI: 10.1007/S11095-014-1472-6  0.715
2014 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. Journal of Pharmaceutical Sciences. 103: 3043-54. PMID 25139193 DOI: 10.1002/Jps.24094  0.439
2014 Christie M, Torres RM, Kedl RM, Randolph TW, Carpenter JF. Recombinant murine growth hormone particles are more immunogenic with intravenous than subcutaneous administration. Journal of Pharmaceutical Sciences. 103: 128-39. PMID 25133276 DOI: 10.1002/Jps.23794  0.363
2014 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. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft FüR Pharmazeutische Verfahrenstechnik E.V. 88: 332-41. PMID 24859390 DOI: 10.1016/J.Ejpb.2014.05.012  0.614
2014 Liu L, Braun LJ, Wang W, Randolph TW, Carpenter JF. Freezing-induced perturbation of tertiary structure of a monoclonal antibody. Journal of Pharmaceutical Sciences. 103: 1979-86. PMID 24832730 DOI: 10.1002/Jps.24013  0.435
2014 Mehta SB, Bee JS, Randolph TW, Carpenter JF. Partial unfolding of a monoclonal antibody: role of a single domain in driving protein aggregation. Biochemistry. 53: 3367-77. PMID 24804773 DOI: 10.1021/Bi5002163  0.731
2014 Fradkin AH, Mozziconacci O, Schöneich C, Carpenter JF, Randolph TW. UV photodegradation of murine growth hormone: chemical analysis and immunogenicity consequences. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft FüR Pharmazeutische Verfahrenstechnik E.V. 87: 395-402. PMID 24758742 DOI: 10.1016/J.Ejpb.2014.04.005  0.783
2014 Gerhardt A, Mcgraw NR, Schwartz DK, Bee JS, Carpenter JF, Randolph TW. Protein aggregation and particle formation in prefilled glass syringes. Journal of Pharmaceutical Sciences. 103: 1601-12. PMID 24729310 DOI: 10.1002/Jps.23973  0.728
2014 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. Journal of Pharmaceutical Sciences. 103: 1356-66. PMID 24623139 DOI: 10.1002/Jps.23926  0.6
2014 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 Journal of Pharmaceutical Sciences. 103: 890-899. PMID 24549732 DOI: 10.1002/Jps.23881  0.33
2014 Basu P, Blake-Haskins AW, O'Berry KB, Randolph TW, Carpenter JF. Albinterferon α2b adsorption to silicone oil-water interfaces: effects on protein conformation, aggregation, and subvisible particle formation. Journal of Pharmaceutical Sciences. 103: 427-36. PMID 24382812 DOI: 10.1002/Jps.23821  0.35
2014 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. Journal of Pharmaceutical Sciences. 103: 140-51. PMID 24282078 DOI: 10.1002/Jps.23801  0.329
2014 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. Journal of Pharmaceutical Sciences. 103: 78-89. PMID 24227137 DOI: 10.1002/Jps.23772  0.689
2013 Liu L, Qi W, Schwartz DK, Randolph TW, Carpenter JF. The effects of excipients on protein aggregation during agitation: an interfacial shear rheology study. Journal of Pharmaceutical Sciences. 102: 2460-70. PMID 23712900 DOI: 10.1002/Jps.23622  0.444
2013 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. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft FüR Pharmazeutische Verfahrenstechnik E.V. 85: 177-83. PMID 23692695 DOI: 10.1016/J.Ejpb.2013.05.004  0.324
2013 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. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fã¼R Pharmazeutische Verfahrenstechnik E.V. 85: 279-86. PMID 23583494 DOI: 10.1016/J.Ejpb.2013.03.029  0.778
2013 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. Journal of Pharmaceutical Sciences. 102: 852-65. PMID 23280943 DOI: 10.1002/Jps.23434  0.366
2013 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. Journal of Pharmaceutical Sciences. 102: 429-40. PMID 23212809 DOI: 10.1002/Jps.23408  0.712
2013 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. Journal of Pharmaceutical Sciences. 102: 660-73. PMID 23203978 DOI: 10.1002/Jps.23401  0.364
2013 Xu Y, Carpenter JF, Cicerone MT, Randolph TW. Contributions of local mobility and degree of retention of native secondary structure to the stability of recombinant human growth hormone (rhGH) in glassy lyophilized formulations Soft Matter. 9: 7855-7865. DOI: 10.1039/C3Sm51251G  0.611
2012 Britt KA, Schwartz DK, Wurth C, Mahler HC, Carpenter JF, Randolph TW. Excipient effects on humanized monoclonal antibody interactions with silicone oil emulsions. Journal of Pharmaceutical Sciences. 101: 4419-32. PMID 22987313 DOI: 10.1002/Jps.23318  0.315
2012 Liu L, Randolph TW, Carpenter JF. Particles shed from syringe filters and their effects on agitation-induced protein aggregation. Journal of Pharmaceutical Sciences. 101: 2952-9. PMID 22674153 DOI: 10.1002/Jps.23225  0.334
2012 Chou DK, Krishnamurthy R, Manning MC, Randolph TW, Carpenter JF. Physical stability of albinterferon-α(2b) in aqueous solution: effects of conformational stability and colloidal stability on aggregation. Journal of Pharmaceutical Sciences. 101: 2702-19. PMID 22674119 DOI: 10.1002/Jps.23215  0.387
2012 Cordes AA, Carpenter JF, Randolph TW. Accelerated stability studies of abatacept formulations: Comparison of freeze-thawing- and agitation-induced stresses Journal of Pharmaceutical Sciences. 101: 2307-2315. PMID 22488299 DOI: 10.1002/Jps.23150  0.808
2012 Cordes AA, Carpenter JF, Randolph TW. Selective domain stabilization as a strategy to reduce human serum albumin-human granulocyte colony stimulating factor aggregation rate Journal of Pharmaceutical Sciences. 101: 2009-2016. PMID 22422106 DOI: 10.1002/Jps.23118  0.804
2012 Cordes AA, Platt CW, Carpenter JF, Randolph TW. Selective domain stabilization as a strategy to reduce fusion protein aggregation Journal of Pharmaceutical Sciences. 101: 1400-1409. PMID 22234888 DOI: 10.1002/Jps.23049  0.811
2012 Jiskoot W, Randolph TW, Volkin DB, Middaugh CR, Schöneich 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. Journal of Pharmaceutical Sciences. 101: 946-54. PMID 22170395 DOI: 10.1002/Jps.23018  0.331
2012 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. Journal of Pharmaceutical Sciences. 101: 187-99. PMID 21918983 DOI: 10.1002/Jps.22744  0.345
2012 Bee JS, Schwartz DK, Trabelsi S, Freund E, Stevenson JL, Carpenter JF, Randolph TW. Production of particles of therapeutic proteins at the air-water interface during compression/dilation cycles Soft Matter. 8: 10329-10335. DOI: 10.1039/C2Sm26184G  0.732
2011 Fradkin AH, Carpenter JF, Randolph TW. Glass particles as an adjuvant: a model for adverse immunogenicity of therapeutic proteins. Journal of Pharmaceutical Sciences. 100: 4953-64. PMID 21721003 DOI: 10.1002/Jps.22683  0.806
2011 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. Journal of Pharmaceutical Sciences. 100: 4215-24. PMID 21557223 DOI: 10.1002/Jps.22601  0.645
2011 Bee JS, Randolph TW, Carpenter JF, Bishop SM, Dimitrova MN. Effects of surfaces and leachables on the stability of biopharmaceuticals. Journal of Pharmaceutical Sciences. 100: 4158-70. PMID 21523787 DOI: 10.1002/Jps.22597  0.744
2011 Ludwig DB, Webb JN, Fernández C, Carpenter JF, Randolph TW. Quaternary conformational stability: the effect of reversible self-association on the fibrillation of two insulin analogs. Biotechnology and Bioengineering. 108: 2359-70. PMID 21520027 DOI: 10.1002/Bit.23188  0.709
2011 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. Analytical Biochemistry. 410: 191-9. PMID 21146492 DOI: 10.1016/J.Ab.2010.12.008  0.782
2011 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. Journal of Pharmaceutical Sciences. 100: 836-48. PMID 20862672 DOI: 10.1002/Jps.22345  0.399
2011 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. Journal of Pharmaceutical Sciences. 100: 492-503. PMID 20803602 DOI: 10.1002/Jps.22305  0.402
2011 Hoehne M, Samuel F, Dong A, Wurth C, Mahler HC, Carpenter JF, Randolph TW. Adsorption of monoclonal antibodies to glass microparticles. Journal of Pharmaceutical Sciences. 100: 123-32. PMID 20575075 DOI: 10.1002/Jps.22275  0.329
2010 Crisman RL, Randolph TW. Crystallization of recombinant human growth hormone at elevated pressures: pressure effects on PEG-induced volume exclusion interactions. Biotechnology and Bioengineering. 107: 663-72. PMID 20589675 DOI: 10.1002/Bit.22832  0.783
2010 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. Biotechnology Progress. 26: 743-9. PMID 20196161 DOI: 10.1002/Btpr.393  0.792
2010 Salinas BA, Sathish HA, Shah AU, Carpenter JF, Randolph TW. Buffer-dependent fragmentation of a humanized full-length monoclonal antibody. Journal of Pharmaceutical Sciences. 99: 2962-74. PMID 20091831 DOI: 10.1002/Jps.22056  0.782
2010 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. Journal of Pharmaceutical Sciences. 99: 2200-8. PMID 19918982 DOI: 10.1002/Jps.21989  0.362
2010 Ludwig DB, Carpenter JF, Hamel JB, Randolph TW. Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions. Journal of Pharmaceutical Sciences. 99: 1721-33. PMID 19894257 DOI: 10.1002/Jps.21982  0.571
2010 Serno T, Carpenter JF, Randolph TW, Winter G. Inhibition of agitation-induced aggregation of an IgG-antibody by hydroxypropyl-beta-cyclodextrin. Journal of Pharmaceutical Sciences. 99: 1193-206. PMID 19774651 DOI: 10.1002/Jps.21931  0.431
2010 Bee JS, Davis M, Freund E, Carpenter JF, Randolph TW. Aggregation of a monoclonal antibody induced by adsorption to stainless steel. Biotechnology and Bioengineering. 105: 121-9. PMID 19725039 DOI: 10.1002/Bit.22525  0.724
2010 Salinas BA, Sathish HA, Bishop SM, Harn N, Carpenter JF, Randolph TW. Understanding and modulating opalescence and viscosity in a monoclonal antibody formulation. Journal of Pharmaceutical Sciences. 99: 82-93. PMID 19475558 DOI: 10.1002/Jps.21797  0.791
2009 Fast JL, Cordes AA, Carpenter JF, Randolph TW. Physical instability of a therapeutic Fc fusion protein: domain contributions to conformational and colloidal stability. Biochemistry. 48: 11724-36. PMID 19899812 DOI: 10.1021/Bi900853V  0.807
2009 Fradkin AH, Carpenter JF, Randolph TW. Immunogenicity of aggregates of recombinant human growth hormone in mouse models. Journal of Pharmaceutical Sciences. 98: 3247-64. PMID 19569057 DOI: 10.1002/Jps.21834  0.812
2009 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. Journal of Pharmaceutical Sciences. 98: 3218-38. PMID 19492408 DOI: 10.1002/Jps.21768  0.72
2009 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. Biotechnology and Bioengineering. 103: 936-43. PMID 19370772 DOI: 10.1002/Bit.22336  0.726
2009 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. Journal of Pharmaceutical Sciences. 98: 3167-81. PMID 19360857 DOI: 10.1002/Jps.21719  0.349
2009 Olsen SN, Andersen KB, Randolph TW, Carpenter JF, Westh P. Role of electrostatic repulsion on colloidal stability of Bacillus halmapalus alpha-amylase Biochimica Et Biophysica Acta - Proteins and Proteomics. 1794: 1058-1065. PMID 19281873 DOI: 10.1016/J.Bbapap.2009.02.010  0.42
2009 Bee JS, Nelson SA, Freund E, Carpenter JF, Randolph TW. Precipitation of a monoclonal antibody by soluble tungsten. Journal of Pharmaceutical Sciences. 98: 3290-301. PMID 19230018 DOI: 10.1002/Jps.21707  0.724
2009 Crisman RL, Randolph TW. Refolding of proteins from inclusion bodies is favored by a diminished hydrophobic effect at elevated pressures. Biotechnology and Bioengineering. 102: 483-92. PMID 18781701 DOI: 10.1002/Bit.22082  0.802
2009 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. Journal of Pharmaceutical Sciences. 98: 2994-3012. PMID 18781606 DOI: 10.1002/Jps.21543  0.359
2009 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. Journal of Pharmaceutical Sciences. 98: 1201-5. PMID 18704929 DOI: 10.1002/Jps.21530  0.443
2009 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. Journal of Pharmaceutical Sciences. 98: 2970-93. PMID 18680175 DOI: 10.1002/Jps.21498  0.389
2009 Katayama DS, Carpenter JF, Menard KP, Manning MC, Randolph TW. Mixing properties of lyophilized protein systems: a spectroscopic and calorimetric study. Journal of Pharmaceutical Sciences. 98: 2954-69. PMID 18623211 DOI: 10.1002/Jps.21467  0.376
2009 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. Journal of Pharmaceutical Sciences. 98: 114-21. PMID 18506831 DOI: 10.1002/Jps.21433  0.788
2009 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. Journal of Pharmaceutical Sciences. 98: 94-104. PMID 18454482 DOI: 10.1002/Jps.21419  0.366
2009 Gabrielson JP, Arthur KK, Kendrick BS, Randolph TW, Stoner MR. Common excipients impair detection of protein aggregates during sedimentation velocity analytical ultracentrifugation. Journal of Pharmaceutical Sciences. 98: 50-62. PMID 18425806 DOI: 10.1002/Jps.21403  0.796
2008 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. Journal of Pharmaceutical Sciences. 97: 5132-46. PMID 18399536 DOI: 10.1002/Jps.21409  0.326
2008 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. Journal of Pharmaceutical Sciences. 97: 5252-62. PMID 18398901 DOI: 10.1002/Jps.21390  0.778
2008 Alford JR, Kendrick BS, Carpenter JF, Randolph TW. Measurement of the second osmotic virial coefficient for protein solutions exhibiting monomer-dimer equilibrium. Analytical Biochemistry. 377: 128-33. PMID 18395000 DOI: 10.1016/J.Ab.2008.03.032  0.697
2008 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. Journal of Pharmaceutical Sciences. 97: 3035-50. PMID 17973297 DOI: 10.1002/Jps.21199  0.686
2008 Alford JR, Kendrick BS, Carpenter JF, Randolph TW. High concentration formulations of recombinant human interleukin-1 receptor antagonist: II. Aggregation kinetics. Journal of Pharmaceutical Sciences. 97: 3005-21. PMID 17924426 DOI: 10.1002/Jps.21205  0.722
2008 Clausi AL, Merkley SA, Carpenter JF, Randolph TW. Inhibition of aggregation of aluminum hydroxide adjuvant during freezing and drying. Journal of Pharmaceutical Sciences. 97: 2049-61. PMID 17879291 DOI: 10.1002/Jps.21143  0.805
2008 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. Journal of Pharmaceutical Sciences. 97: 1801-12. PMID 17823949 DOI: 10.1002/Jps.21110  0.432
2008 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. Journal of Pharmaceutical Sciences. 97: 1013-24. PMID 17724657 DOI: 10.1002/Jps.20991  0.303
2008 Alford JR, Kendrick BS, Carpenter JF, Randolph TW. Corrigendum to "Measurement of the second osmotic virial coefficient for protein solutions exhibiting monomer-dimer equilibrium" [Anal. Biochem. 377 (2008) 128-133] (DOI:10.1016/j.ab.2008.03.032) Analytical Biochemistry. 383: 349. DOI: 10.1016/J.Ab.2008.08.007  0.681
2007 Downey CD, Crisman RL, Randolph TW, Pardi A. Influence of hydrostatic pressure and cosolutes on RNA tertiary structure. Journal of the American Chemical Society. 129: 9290-1. PMID 17616193 DOI: 10.1021/Ja072179K  0.769
2007 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. Journal of Pharmaceutical Sciences. 96: 2375-89. PMID 17518359 DOI: 10.1002/Jps.20880  0.316
2007 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. 46: 6213-24. PMID 17480058 DOI: 10.1021/Bi700321G  0.348
2007 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. Biotechnology and Bioengineering. 98: 476-85. PMID 17335058 DOI: 10.1002/Bit.21398  0.796
2007 Gabrielson JP, Randolph TW, Kendrick BS, Stoner MR. Sedimentation velocity analytical ultracentrifugation and SEDFIT/c(s): limits of quantitation for a monoclonal antibody system. Analytical Biochemistry. 361: 24-30. PMID 17181992 DOI: 10.1016/J.Ab.2006.11.012  0.789
2007 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. Journal of Pharmaceutical Sciences. 96: 268-79. PMID 17080424 DOI: 10.1002/Jps.20760  0.764
2006 Kim YS, Randolph TW, Seefeldt MB, Carpenter JF. High-pressure studies on protein aggregates and amyloid fibrils. Methods in Enzymology. 413: 237-53. PMID 17046400 DOI: 10.1016/S0076-6879(06)13013-X  0.819
2006 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. Journal of Pharmaceutical Sciences. 95: 1480-97. PMID 16729274 DOI: 10.1002/Jps.20619  0.306
2006 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. 45: 3898-911. PMID 16548517 DOI: 10.1021/Bi052132G  0.316
2006 Stoner MR, Dale DA, Gualfetti PJ, Becker T, Randolph TW. Surfactant-induced unfolding of cellulase: kinetic studies. Biotechnology Progress. 22: 225-32. PMID 16454514 DOI: 10.1021/Bp0501468  0.723
2006 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 Science : a Publication of the Protein Society. 15: 304-13. PMID 16385003 DOI: 10.1110/Ps.051813506  0.375
2006 Jarmer DJ, Lengsfeld CS, Randolph TW. Scale-up criteria for an injector with a confined mixing chamber during precipitation with a compressed-fluid antisolvent Journal of Supercritical Fluids. 37: 242-253. DOI: 10.1016/J.Supflu.2005.10.003  0.773
2005 Stoner MR, Dale DA, Gualfetti PJ, Becker T, Randolph TW. Ca2+-surfactant interactions affect enzyme stability in detergent solutions. Biotechnology Progress. 21: 1716-23. PMID 16321056 DOI: 10.1021/Bp050149K  0.666
2005 Chi EY, Kendrick BS, Carpenter JF, Randolph TW. Population balance modeling of aggregation kinetics of recombinant human interleukin-1 receptor antagonist. Journal of Pharmaceutical Sciences. 94: 2735-48. PMID 16258998 DOI: 10.1002/Jps.20488  0.571
2005 Jarmer DJ, Lengsfeld CS, Anseth KS, Randolph TW. Supercritical fluid crystallization of griseofulvin: crystal habit modification with a selective growth inhibitor. Journal of Pharmaceutical Sciences. 94: 2688-702. PMID 16258994 DOI: 10.1002/Jps.20463  0.768
2005 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 Science : a Publication of the Protein Society. 14: 2258-66. PMID 16081653 DOI: 10.1110/Ps.051490205  0.801
2005 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. Journal of Controlled Release : Official Journal of the Controlled Release Society. 107: 288-99. PMID 16009444 DOI: 10.1016/J.Jconrel.2005.06.009  0.718
2005 Chou DK, Krishnamurthy R, Randolph TW, Carpenter JF, Manning MC. Effects of Tween 20 and Tween 80 on the stability of Albutropin during agitation. Journal of Pharmaceutical Sciences. 94: 1368-81. PMID 15858848 DOI: 10.1002/Jps.20365  0.42
2005 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. Journal of Pharmaceutical Sciences. 94: 382-96. PMID 15614819 DOI: 10.1002/Jps.20258  0.37
2005 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. Journal of Pharmaceutical Sciences. 94: 256-74. PMID 15570600 DOI: 10.1002/Jps.20237  0.616
2005 Chi EY, Lee KYC, Randolph TW. Protein aggregation in the pathogenesis of amyloid diseases Aiche Annual Meeting, Conference Proceedings. 3518.  0.544
2005 Hesterberg LK, Seefeldt MB, Carpenter JF, Randolph TW. High-hydrostatic pressure refolding of proteins Genetic Engineering News. 25: 46-47.  0.795
2005 Seefeldt MB, Webb JN, Carpenter JF, Randolph TW, Hesterberg LK. Enhanced refolding of recombinant proteins using high hydrostatic pressure American Biotechnology Laboratory. 23.  0.794
2004 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. Journal of Pharmaceutical Sciences. 93: 3076-89. PMID 15514986 DOI: 10.1002/Jps.20219  0.349
2004 Seefeldt MB, Ouyang J, Froland WA, Carpenter JF, Randolph TW. High-pressure refolding of bikunin: efficacy and thermodynamics. Protein Science : a Publication of the Protein Society. 13: 2639-50. PMID 15388859 DOI: 10.1110/Ps.04891204  0.809
2004 Jarmer DJ, Lengsfeld CS, Randolph TW. Nucleation and growth rates of poly(L-lactic acid) microparticles during precipitation with a compressed-fluid antisolvent. Langmuir : the Acs Journal of Surfaces and Colloids. 20: 7254-64. PMID 15301513 DOI: 10.1021/La049912V  0.779
2004 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. Journal of Pharmaceutical Sciences. 93: 2332-42. PMID 15295793 DOI: 10.1002/Jps.20145  0.723
2004 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. Journal of Pharmaceutical Sciences. 93: 684-96. PMID 14762907 DOI: 10.1002/Jps.10587  0.369
2004 Stoner MR, Dale DA, Gualfetti PJ, Becker T, Manning MC, Carpenter JF, Randolph TW. Protease autolysis in heavy-duty liquid detergent formulations: Effects of thermodynamic stabilizers and protease inhibitors Enzyme and Microbial Technology. 34: 114-125. DOI: 10.1016/J.Enzmictec.2003.09.008  0.704
2003 Chi EY, Krishnan S, Randolph TW, Carpenter JF. Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation. Pharmaceutical Research. 20: 1325-36. PMID 14567625 DOI: 10.1023/A:1025771421906  0.627
2003 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. Journal of Controlled Release : Official Journal of the Controlled Release Society. 92: 147-61. PMID 14499193 DOI: 10.1016/S0168-3659(03)00325-0  0.762
2003 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 Science : a Publication of the Protein Society. 12: 1252-61. PMID 12761396 DOI: 10.1110/Ps.0242603  0.38
2003 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 Science : a Publication of the Protein Society. 12: 903-13. PMID 12717013 DOI: 10.1110/Ps.0235703  0.61
2003 Webb SD, Cleland JL, Carpenter JF, Randolph TW. Effects of annealing lyophilized and spray-lyophilized formulations of recombinant human interferon-gamma. Journal of Pharmaceutical Sciences. 92: 715-29. PMID 12661058 DOI: 10.1002/Jps.10334  0.643
2003 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. 42: 829-37. PMID 12534296 DOI: 10.1021/Bi026528T  0.521
2003 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. The Journal of Biological Chemistry. 278: 10842-50. PMID 12529361 DOI: 10.1074/Jbc.M212540200  0.387
2003 Owens JL, Anseth KS, Randolph TW. Mechanism of microparticle formation in the compressed antisolvent precipitation and photopolymerization (CAPP) process Langmuir. 19: 3926-3934. DOI: 10.1021/La0208272  0.332
2003 Jarmer DJ, Lengsfeld CS, Randolph TW. Manipulation of particle size distribution of poly(L-lactic acid) nanoparticles with a jet-swirl nozzle during precipitation with a compressed antisolvent Journal of Supercritical Fluids. 27: 317-336. DOI: 10.1016/S0896-8446(02)00245-0  0.773
2002 Carpenter JF, Manning MC, Randolph TW. Long-term storage of proteins. Current Protocols in Protein Science / Editorial Board, John E. Coligan ... [Et Al.]. Unit 4.6. PMID 18429236 DOI: 10.1002/0471140864.Ps0406S27  0.346
2002 Lengsfeld CS, Pitera D, Manning M, Randolph TW. Dissolution and partitioning behavior of hydrophobic ion-paired compounds. Pharmaceutical Research. 19: 1572-6. PMID 12425478 DOI: 10.1023/A:1020429321350  0.64
2002 Lengsfeld CS, Manning MC, Randolph TW. Encapsulating DNA within biodegradable polymeric microparticles. Current Pharmaceutical Biotechnology. 3: 227-35. PMID 12164479 DOI: 10.2174/1389201023378300  0.625
2002 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. Journal of Pharmaceutical Sciences. 91: 1502-11. PMID 12115849 DOI: 10.1002/Jps.10116  0.652
2002 Webb SD, Golledge SL, Cleland JL, Carpenter JF, Randolph TW. Surface adsorption of recombinant human interferon-gamma in lyophilized and spray-lyophilized formulations. Journal of Pharmaceutical Sciences. 91: 1474-87. PMID 12115847 DOI: 10.1002/Jps.10135  0.638
2002 St John RJ, Carpenter JF, Randolph TW. High-pressure refolding of disulfide-cross-linked lysozyme aggregates: thermodynamics and optimization. Biotechnology Progress. 18: 565-71. PMID 12052074 DOI: 10.1021/Bp0200200  0.37
2002 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. The Journal of Biological Chemistry. 277: 27240-6. PMID 12023282 DOI: 10.1074/Jbc.M202492200  0.389
2002 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. 41: 6422-31. PMID 12009905 DOI: 10.1021/Bi012006M  0.741
2002 Randolph TW, Seefeldt M, Carpenter JF. High hydrostatic pressure as a tool to study protein aggregation and amyloidosis. Biochimica Et Biophysica Acta. 1595: 224-34. PMID 11983398 DOI: 10.1016/S0167-4838(01)00346-6  0.819
2002 Webb SD, Cleland JL, Carpenter JF, Randolph TW. A new mechanism for decreasing aggregation of recombinant human interferon-gamma by a surfactant: slowed dissolution of lyophilized formulations in a solution containing 0.03% polysorbate 20. Journal of Pharmaceutical Sciences. 91: 543-58. PMID 11835212 DOI: 10.1002/Jps.10033  0.689
2002 Owens JL, Anseth KS, Randolph TW. Compressed antisolvent precipitation and photopolymerization to form highly cross-linked polymer particles Macromolecules. 35: 4289-4296. DOI: 10.1021/Ma011955K  0.32
2002 DePaz RA, Dale DA, Barnett CC, Carpenter JF, Gaertner AL, Randolph TW. Effects of drying methods and additives on the structure, function, and storage stability of subtilisin: Role of protein conformation and molecular mobility Enzyme and Microbial Technology. 31: 765-774. DOI: 10.1016/S0141-0229(02)00173-4  0.8
2002 Randolph TW, Searles JA. Freezing and annealing phenomena in lyophilization: Effect upon primary drying rate, morphology, and heterogeneity American Pharmaceutical Review. 5: 40-46.  0.751
2001 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. Journal of Pharmaceutical Sciences. 90: 1466-77. PMID 11745706 DOI: 10.1002/Jps.1098  0.398
2001 Webb SD, Koval CA, Randolph CM, Randolph TW. Electrochemical determination of dissolution rates of lyophilized pharmaceutical formulations. Analytical Chemistry. 73: 5296-301. PMID 11721932 DOI: 10.1021/Ac0102720  0.608
2001 St John RJ, Carpenter JF, Balny C, Randolph TW. High pressure refolding of recombinant human growth hormone from insoluble aggregates. Structural transformations, kinetic barriers, and energetics. The Journal of Biological Chemistry. 276: 46856-63. PMID 11591710 DOI: 10.1074/Jbc.M107671200  0.412
2001 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. Journal of Pharmaceutical Sciences. 90: 872-87. PMID 11458336 DOI: 10.1002/Jps.1040  0.774
2001 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. Journal of Pharmaceutical Sciences. 90: 860-71. PMID 11458335 DOI: 10.1002/Jps.1039  0.767
2001 Webb JN, Webb SD, Cleland JL, Carpenter JF, Randolph TW. Partial molar volume, surface area, and hydration changes for equilibrium unfolding and formation of aggregation transition state: high-pressure and cosolute studies on recombinant human IFN-gamma. Proceedings of the National Academy of Sciences of the United States of America. 98: 7259-64. PMID 11381145 DOI: 10.1073/Pnas.131194798  0.746
2001 Anchordoquy TJ, Izutsu KI, Randolph TW, Carpenter JF. Maintenance of quaternary structure in the frozen state stabilizes lactate dehydrogenase during freeze-drying. Archives of Biochemistry and Biophysics. 390: 35-41. PMID 11368512 DOI: 10.1006/Abbi.2001.2351  0.352
2001 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. The Journal of Biological Chemistry. 276: 1626-33. PMID 11050093 DOI: 10.1074/Jbc.M007766200  0.583
2000 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. Archives of Biochemistry and Biophysics. 384: 123-32. PMID 11147823 DOI: 10.1006/Abbi.2000.2106  0.787
2000 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. Journal of Pharmaceutical Sciences. 89: 1480-5. PMID 11015692 DOI: 10.1002/1520-6017(200011)89:11<1480::Aid-Jps10>3.0.Co;2-M  0.358
2000 Webb JN, Carpenter JF, Randolph TW. Stability of subtilisin and lysozyme under high hydrostatic pressure. Biotechnology Progress. 16: 630-6. PMID 10933838 DOI: 10.1021/Bp0000499  0.671
2000 Dong A, Randolph TW, Carpenter JF. Entrapping intermediates of thermal aggregation in α-helical proteins with low concentration of guanidine hydrochloride Journal of Biological Chemistry. 275: 27689-27693. PMID 10871628 DOI: 10.1074/Jbc.M005374200  0.354
2000 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 Journal of Pharmaceutical Sciences. 89: 199-214. PMID 10688749 DOI: 10.1002/(Sici)1520-6017(200002)89:2<199::Aid-Jps7>3.0.Co;2-B  0.376
2000 Kim Y, Wall JS, Meyer J, Murphy C, Randolph TW, Manning MC, Solomon A, Carpenter JF. Thermodynamic modulation of light chain amyloid fibril formation. The Journal of Biological Chemistry. 275: 1570-4. PMID 10636846 DOI: 10.1074/Jbc.275.3.1570  0.395
2000 Lengsfeld CS, Delplanque JP, Barocas VH, Randolph TW. Mechanism Governing Microparticle Morphology during Precipitation by a Compressed Antisolvent: Atomization vs Nucleation and Growth Journal of Physical Chemistry B. 104: 2725-2735. DOI: 10.1021/Jp9931511  0.664
2000 Waghmare RY, Webb JN, Randolph TW, Larson MA, Glatz CE. Pressure dependence of subtilisin crystallization kinetics Journal of Crystal Growth. 208: 678-686. DOI: 10.1016/S0022-0248(99)00388-7  0.618
1999 St John RJ, Carpenter JF, Randolph TW. High pressure fosters protein refolding from aggregates at high concentrations. Proceedings of the National Academy of Sciences of the United States of America. 96: 13029-33. PMID 10557267 DOI: 10.1073/Pnas.96.23.13029  0.412
1999 Carpenter JF, Kendrick BS, Chang BS, Manning MC, Randolph TW. Inhibition of stress-induced aggregation of protein therapeutics Methods in Enzymology. 309: 236-255. PMID 10507028 DOI: 10.1016/S0076-6879(99)09018-7  0.417
1999 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 Pharmaceutical Research. 16: 808-812. PMID 10397598 DOI: 10.1023/A:1018809632395  0.308
1999 Allison SD, Chang B, Randolph TW, Carpenter JF. Hydrogen bonding between sugar and protein is responsible for inhibition of dehydration-induced protein unfolding Archives of Biochemistry and Biophysics. 365: 289-298. PMID 10328824 DOI: 10.1006/Abbi.1999.1175  0.353
1999 Heller MC, Carpenter JF, Randolph TW. Protein formulation and lyophilization cycle design: Prevention of damage due to freeze-concentration induced phase separation Biotechnology and Bioengineering. 63: 166-174. PMID 10099593 DOI: 10.1002/(Sici)1097-0290(19990420)63:2<166::Aid-Bit5>3.0.Co;2-H  0.324
1999 Heller MC, Carpenter JF, Randolph TW. Application of a thermodynamic model to the prediction of phase separations in freeze-concentrated formulations for protein lyophilization Archives of Biochemistry and Biophysics. 363: 191-201. PMID 10068440 DOI: 10.1006/Abbi.1998.1078  0.325
1999 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 Journal of Pharmaceutical Sciences. 88: 281-290. PMID 10052984 DOI: 10.1021/Js980399D  0.39
1999 Heller MC, Carpenter JF, Randolph TW. Conformational stability of lyophilized PEGylated proteins in a phase- separating system Journal of Pharmaceutical Sciences. 88: 58-64. PMID 9874703 DOI: 10.1021/Js980257J  0.372
1999 Carpenter JF, Izutsu K, Randolph TW. Freezing- and Drying-Induced Perturbations of Protein Structure and Mechanisms of Protein Protection by Stabilizing Additives Drugs and the Pharmaceutical Sciences. 96: 123-160. DOI: 10.3109/9781439825761-10  0.395
1999 Connon CS, Falk RF, Randolph TW. Role of crystallinity in retention of polymer particle morphology in the presence of compressed carbon dioxide Macromolecules. 32: 1890-1896. DOI: 10.1021/Ma9813035  0.306
1999 Lee CT, Psathas PA, Johnston KP, DeGrazia J, Randolph TW. Water-in-carbon dioxide emulsions: Formation and stability Langmuir. 15: 6781-6791. DOI: 10.1021/La9903548  0.323
1999 Webb JN, Waghmare RY, Carpenter JF, Glatz CE, Randolph TW. Pressure effect on subtilisin crystallization and solubility Journal of Crystal Growth. 205: 563-574. DOI: 10.1016/S0022-0248(99)00305-X  0.626
1998 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. Journal of Pharmaceutical Sciences. 87: 1597-603. PMID 10189273 DOI: 10.1021/Js980126I  0.407
1998 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. Journal of Pharmaceutical Sciences. 87: 1554-9. PMID 10189266 DOI: 10.1021/Js980175V  0.401
1998 Kendrick BS, Carpenter JF, Cleland JL, Randolph TW. A transient expansion of the native state precedes aggregation of recombinant human interferon-γ Proceedings of the National Academy of Sciences of the United States of America. 95: 14142-14146. PMID 9826667 DOI: 10.1073/Pnas.95.24.14142  0.402
1998 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 Archives of Biochemistry and Biophysics. 360: 121-134. PMID 9826437 DOI: 10.1006/Abbi.1998.0948  0.376
1998 Kendrick BS, Cleland JL, Lam X, Nguyen T, Randolph TW, Manning MC, Carpenter JF. Aggregation of recombinant human interferon gamma: Kinetics and structural transitions Journal of Pharmaceutical Sciences. 87: 1069-1076. PMID 9724556 DOI: 10.1021/Js9801384  0.405
1998 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 °C of a recombinant hemoglobin Journal of Pharmaceutical Sciences. 87: 1062-1068. PMID 9724555 DOI: 10.1021/Js980140V  0.387
1997 Randolph TW. Phase separation of excipients during lyophilization: Effects on protein stability Journal of Pharmaceutical Sciences. 86: 1198-1203. PMID 9383725 DOI: 10.1021/Js970135B  0.318
1997 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 Proceedings of the National Academy of Sciences of the United States of America. 94: 11917-11922. PMID 9342337 DOI: 10.1073/Pnas.94.22.11917  0.377
1997 Heller MC, Carpenter JF, Randolph TW. Manipulation of lyophilization-induced phase separation: Implications for pharmaceutical proteins Biotechnology Progress. 13: 590-596. PMID 9336978 DOI: 10.1021/Bp970081B  0.374
1997 Heitz MP, Carlier C, DeGrazia J, Harrison KL, Johnston KP, Randolph TW, Bright FV. Water core within perfluoropolyether-based microemulsions formed in supercritical carbon dioxide Journal of Physical Chemistry B. 101: 6707-6714. DOI: 10.1021/Jp9622243  0.3
1996 Bam NB, Cleland JL, Randolph TW. Molten globule intermediate of recombinant human growth hormone: Stabilization with surfactants Biotechnology Progress. 12: 801-809. PMID 8983207 DOI: 10.1021/Bp960068B  0.388
1996 Heller MC, Carpenter JF, Randolph TW. Effects of phase separating systems on lyophilized hemoglobin Journal of Pharmaceutical Sciences. 85: 1358-1362. PMID 8961153 DOI: 10.1021/Js960019T  0.341
1996 Johnston KP, Harrison KL, Clarke MJ, Howdle SM, Heitz MP, Bright FV, Carlier C, Randolph TW. Water-in-Carbon Dioxide Microemulsions: An Environment for Hydrophiles Including Proteins Science. 271: 624-626. DOI: 10.1126/Science.271.5249.624  0.337
1995 Bam NB, Randolph TW, Cleland JL. Stability of Protein Formulations: Investigation of Surfactant Effects by a Novel EPR Spectroscopic Technique Pharmaceutical Research: An Official Journal of the American Association of Pharmaceutical Scientists. 12: 2-11. PMID 7724484 DOI: 10.1023/A:1016286600229  0.391
1992 Randolph TW, Carlier C. Pressure Control of Reactions in Supercritical Fluids: Thermodynamics and Kinetics Progress in Biotechnology. 8: 93-100. DOI: 10.1016/B978-0-444-89046-7.50020-5  0.319
1990 Randolph TW, Marison IW, Martens DE, Von Stockar U. Calorimetric control of fed-batch fermentations Biotechnology and Bioengineering. 36: 678-684. DOI: 10.1002/Bit.260360705  0.582
1988 Randolph TW, Clark DS, Blanch HW, Prausnitz JM. Enzymatic oxidation of cholesterol aggregates in supercritical carbon dioxide. Science (New York, N.Y.). 239: 387-90. PMID 17836870 DOI: 10.1126/Science.239.4838.387  0.606
1988 Clark DS, Skerker PS, Randolph TW, Blanch HW, Prausnitz JM. Conformational analyses of enzymes and substrates in processing environments. Annals of the New York Academy of Sciences. 542: 16-29. PMID 2852476 DOI: 10.1111/J.1749-6632.1988.Tb25804.X  0.566
1988 Randolph TW, Clark DS, Blanch HW, Prausnitz JM. Cholesterol aggregation and interaction with cholesterol oxidase in supercritical carbon dioxide. Proceedings of the National Academy of Sciences of the United States of America. 85: 2979-83. PMID 2834725 DOI: 10.1073/Pnas.85.9.2979  0.595
1988 Randolph TW, Blanch HW, Prausnitz JM. Enzyme-caytalyzed oxidation of cholesterol in supercritical carbon dioxide Aiche Journal. 34: 1354-1360. DOI: 10.1002/Aic.690340813  0.587
1985 Randolph TW, Blanch HW, Prausnitz JM, Wilke CR. Enzymatic catalysis in a supercritical fluid Biotechnology Letters. 7: 325-328. DOI: 10.1007/Bf01030279  0.579
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