Publications that Reference Pfanstiehl Products

Product Type

Year

Munjal, Bhushan, Sajal M. Patel, and Raj Suryanarayanan. "Role of arginine salts in preventing freezing-induced increase in subvisible particles in protein formulations." International journal of pharmaceutics 619 (2022): 121694
Ren, Steven. "Effects of arginine in therapeutic protein formulations: a decade review and perspectives." Antibody Therapeutics 6.4 (2023): 265-276.
Thacker, Seth G., et al. "Detection of innate immune response modulating impurities (IIRMI) in therapeutic peptides and proteins: Impact of excipients." Frontiers in Immunology 13 (2022): 970499.
Becerra, Sandra C., et al. "Reversibility of replicative senescence in Saccharomyces cerevisiae: effect of homologous recombination and cell cycle checkpoints." DNA repair 11.1 (2012): 35-45.
Berry, Gerard T., et al. "The rate of de novo galactose synthesis in patients with galactose-1-phosphate uridyltransferase deficiency." Molecular genetics and metabolism 81.1 (2004): 22-30
Cote, G. L., and S. M. Holt. "Prebiotic oligosaccharides via alternansucrase acceptor reactions." (2007)
Everson, G. T., et al. "The spectrum of hepatic functional impairment in compensated chronic hepatitis C: results from the Hepatitis C Anti‐viral Long‐term Treatment against Cirrhosis Trial 1." Alimentary pharmacology & therapeutics 27.9 (2008): 798-809
Everson, Gregory T., et al. "Functional elements associated with hepatic regeneration in living donors after right hepatic lobectomy." Liver transplantation 19.3 (2013): 292-304
Lee, Karen, et al. "A biochemical and pharmacological comparison of enzyme replacement therapies for the glycolipid storage disorder Fabry disease." Glycobiology 13.4 (2003): 305-313
Lee, Sang Jun, Dale EA Lewis, and Sankar Adhya. "Induction of the galactose enzymes in Escherichia coli is independent of the C-1-hydroxyl optical configuration of the inducer D-galactose." Journal of bacteriology 190.24 (2008): 7932-7938.
Masuko, Tatsuya, et al. "Carbohydrate analysis by a phenol–sulfuric acid method in microplate format." Analytical biochemistry 339.1 (2005): 69-72
Munoz-Alegre, Marta. Development of a novel system to induce double-strand breaks in mammalian cells. University of London, University College London (United Kingdom), 2007.
Pan, R-L., et al. "Cimifoetisides VI and VII Two new cyclolanostanol triterpene glycosides from the aerial parts of Cimicifuga foetida." Journal of Asian natural products research 9.2 (2007): 97-102.
Sahni, Neha, et al. "Preformulation characterization, stabilization, and formulation design for the acrylodan-labeled glucose-binding protein SM4-AC." Journal of Pharmaceutical Sciences 106.5 (2017): 1197-1210
Sgambat, Kristen, Mindy Banks, and Asha Moudgil. "Effect of galactose on glomerular permeability and proteinuria in steroid-resistant nephrotic syndrome." Pediatric Nephrology 28 (2013): 2131-2135.
Trachtman, Howard, et al. "Efficacy of galactose and adalimumab in patients with resistant focal segmental glomerulosclerosis: report of the font clinical trial group." BMC nephrology 16 (2015): 1-13
Trachtman, Howard, et al. "Novel therapies for resistant focal segmental glomerulosclerosis (FONT) phase II clinical trial: study design." BMC nephrology 12 (2011): 1-8
Yager, Claire, Suzanne Wehrli, and Stanton Segal. "Urinary galactitol and galactonate quantified by isotope-dilution gas chromatography-mass spectrometry." Clinica chimica acta 366.1-2 (2006): 216-224.
Zhou, Qun, et al. "Effect of genetic background on glycosylation heterogeneity in human antithrombin produced in the mammary gland of transgenic goats." Journal of biotechnology 117.1 (2005): 57-72
Grapentin, Christoph, et al. "Protein-polydimethylsiloxane particles in liquid vial monoclonal antibody formulations containing poloxamer 188." Journal of pharmaceutical sciences 109.8 (2020): 2393-2404
Seiler, Vanessa K., et al. "In-situ investigation of solid phase evolution during lyophilization of mannitol-based antibody formulations using an XRPD climate chamber." European Journal of Pharmaceutical Sciences 184 (2023): 106407
Zhang, Xiaozhang, et al. "Multiple approaches to reduce reconstitution time of lyophilized drug products with high protein concentration." Antibody Therapeutics (2023): tbad031.
Zhang, Yilue, and Christian Schöneich. "Visible Light Induces Site-Specific Oxidative Heavy Chain Fragmentation of a Monoclonal Antibody (IgG1) Mediated by an Iron (III)-Containing Histidine Buffer." Molecular Pharmaceutics 20.1 (2022): 650-662
Zhang, Yilue, Maribel Espinoza Ballesteros, and Christian Schöneich. "Photo-induced site-specific oxidative fragmentation of IgG1 mediated by iron (III)-containing histidine buffer: Mechanistic studies and excipient effects." European Journal of Pharmaceutics and Biopharmaceutics 190 (2023): 121-130
Hall, Barry G., Andreas Pikis, and John Thompson. "Evolution and biochemistry of family 4 glycosidases: implications for assigning enzyme function in sequence annotations." Molecular biology and evolution 26.11 (2009): 2487-2497.
Krogstrup, Peter, et al. "Micropropagation of socotran fig, Dorstenia gigas schweinf. Ex Balf. F.—A threatened species, endemic to the island of Socotra, Yemen." In vitro cellular & developmental biology-plant 41 (2005): 81-86.
Nesarikar, Vishwas V., and Munir N. Nassar. "Effect of cations and anions on glass transition temperatures in excipient solutions." Pharmaceutical development and technology 12.3 (2007): 259-264
Pikis, Andreas, et al. "Genetic requirements for growth of Escherichia coli K12 on methyl-α-D-glucopyranoside and the five α-D-glucosyl-D-fructose isomers of sucrose." Journal of biological chemistry 281.26 (2006): 17900-17908.
Thompson, John et al. “The sim operon facilitates the transport and metabolism of sucrose isomers in Lactobacillus casei ATCC 334.” Journal of bacteriology vol. 190,9 (2008): 3362-73. doi:10.1128/JB.02008-07
Thompson, John, and Andreas Pikis. "Metabolism of sugars by genetically diverse species of oral Leptotrichia." Molecular oral microbiology 27.1 (2012): 34-44
Thompson, John, et al. "The sim operon facilitates the transport and metabolism of sucrose isomers in Lactobacillus casei ATCC 334." Journal of bacteriology 190.9 (2008): 3362-3373
Thompson, John, Sonja Hess, and Andreas Pikis. "Genes malh and pagl of Clostridium acetobutylicum ATCC 824 encode NAD+-and Mn2+-dependent phospho-α-glucosidase (s)." Journal of Biological Chemistry 279.2 (2004): 1553-1561.
Bai, Ling, et al. "Investigation of Excipients Impact on Polysorbate 80 Degradation in Biopharmaceutical Formulation Buffers." Journal of Pharmaceutical and Biomedical Analysis (2023): 115496
Bartholomeusz, Daniel A., Rupert H. Davies, and Joseph D. Andrade. "Optical enhanced luminescent measurements and sequential reagent mixing on a centrifugal microfluidic device for multi-analyte point-of-care applications." Advanced Biomedical and Clinical Diagnostic Systems IV. Vol. 6080. SPIE, 2006.
Burger, Jessica L., et al. "Stabilizing formulations for inhalable powders of live-attenuated measles virus vaccine." Journal of aerosol medicine and pulmonary drug delivery 21.1 (2008): 25-34.
Burger, Jessica Lynne. Stabilization of live attenuated measles virus vaccine in glassy matrices. Diss. University of Colorado at Boulder, 2009
Davies, Rupert Hugo. Luminescent assays for the assessment of metabolism and renal function: Towards a multianalyte biosensor. The University of Utah, 2005
Jameel, Feroz, et al. "Development of freeze-dried biosynthetic Factor VIII: I. A case study in the optimization of formulation." Pharmaceutical Development and Technology 14.6 (2009): 687-697
Ji, Junyan A., et al. "Methionine, tryptophan, and histidine oxidation in a model protein, PTH: mechanisms and stabilization." Journal of pharmaceutical sciences 98.12 (2009): 4485-4500.
Kumru, Ozan S., et al. "Physical characterization and stabilization of a lentiviral vector against adsorption and freeze-thaw." Journal of Pharmaceutical Sciences 107.11 (2018): 2764-2774
Kumru, Ozan S., et al. "Stabilization and formulation of a recombinant Human Cytomegalovirus vector for use as a candidate HIV-1 vaccine." Vaccine 37.44 (2019): 6696-6706.
Lu, Xiaofeng, and Michael J. Pikal. "Freeze‐drying of mannitol–trehalose–sodium chloride‐based formulations: The impact of annealing on dry layer resistance to mass transfer and cake structure." Pharmaceutical development and technology 9.1 (2004): 85-95
Meyer, Jeffrey D., Rajiv Nayar, and Mark Cornell Manning. "Impact of bulking agents on the stability of a lyophilized monoclonal antibody." European journal of pharmaceutical sciences 38.1 (2009): 29-38
Moorthy, Balakrishnan S., et al. "Solid-state hydrogen–deuterium exchange mass spectrometry: correlation of deuterium uptake and long-term stability of lyophilized monoclonal antibody formulations." Molecular pharmaceutics 15.1 (2018): 1-11
Pena-Rodríguez, Eloy, et al. "The physicochemical, biopharmaceutical, and in vitro efficacy properties of freeze-dried dexamethasone-loaded lipomers." Pharmaceutics 13.8 (2021): 1322
Roy, Shouvik. Mechanistic studies of physico-chemical stability of model therapeutic proteins using pharmaceutically relevant factors. University of Colorado Health Sciences Center, 2006
Thacker, Seth G., et al. "Detection of innate immune response modulating impurities (IIRMI) in therapeutic peptides and proteins: Impact of excipients." Frontiers in Immunology 13 (2022): 970499.
TOPRANI, VISHAL M. TOWARDS A BETTER UNDERSTANDING OF VACCINE STABILITY AS APPLIED TO PHARMACEUTICAL DEVELOPMENT OF VARIOUS RECOMBINANT PROTEIN VACCINE CANDIDATES. Diss. University of Kansas, 2018
Toprani, Vishal M., et al. "Development of a candidate stabilizing formulation for bulk storage of a double mutant heat labile toxin (dmLT) protein based adjuvant." Vaccine 35.41 (2017): 5471-5480
Villa, Joseph Anthony. Generation and characterization of fine and stable powders suitable for pulmonary drug delivery using carbon dioxide-assisted nebulization with a Bubble Dryer (CAN-BD). University of Colorado at Boulder, 2004
Wan, Ying, et al. "Formulation development and improved stability of a combination measles and rubella live-viral vaccine dried for use in the NanopatchTM microneedle delivery system." Human Vaccines & Immunotherapeutics 17.8 (2021): 2501-2516.
Yang, Xiaoyun. Towards the development of an immunochip for therapeutic monitoring of antiepileptic drugs. The University of Utah, 2006
Yoon, Kyu, and Vivek Narsimhan. "Comparison of vial heat transfer coefficients during the primary and secondary drying stages of freeze-drying." International Journal of Pharmaceutics 635 (2023): 122746
Yoon, Kyu, and Vivek Narsimhan. "Understanding heat transfer during the secondary drying stage of freeze drying: current practice and knowledge gaps." Journal of Pharmaceutical Sciences 111.2 (2022): 368-381
Zhang, Yilue, Maribel Espinoza Ballesteros, and Christian Schöneich. "Photo-induced site-specific oxidative fragmentation of IgG1 mediated by iron (III)-containing histidine buffer: Mechanistic studies and excipient effects." European Journal of Pharmaceutics and Biopharmaceutics 190 (2023): 121-130
Zillies, Jan C., et al. "Formulation development of freeze-dried oligonucleotide-loaded gelatin nanoparticles." European Journal of Pharmaceutics and Biopharmaceutics 70.2 (2008): 514-521
Zillies, Jan. Gelatin nanoparticles for targeted oligonucleotide delivery to Kupffer cells-analytics, formulation development, practical application. Diss. lmu, 2007
Garate, Marco, et al. "Biochemical characterization and functional studies of Acanthamoeba mannose-binding protein." Infection and Immunity 73.9 (2005): 5775-5781
Lee, Karen, et al. "A biochemical and pharmacological comparison of enzyme replacement therapies for the glycolipid storage disorder Fabry disease." Glycobiology 13.4 (2003): 305-313
Masuko, Tatsuya, et al. "Carbohydrate analysis by a phenol–sulfuric acid method in microplate format." Analytical biochemistry 339.1 (2005): 69-72
Zhou, Qun, et al. "Effect of genetic background on glycosylation heterogeneity in human antithrombin produced in the mammary gland of transgenic goats." Journal of biotechnology 117.1 (2005): 57-72
Abdul‐Fattah, Ahmad M., et al. "Drying-induced variations in physico-chemical properties of amorphous pharmaceuticals and their impact on stability (I): Stability of a monoclonal antibody." Journal of Pharmaceutical Sciences 96.8 (2007): 1983-2008.
Abdul-Fattah, Ahmad M., et al. "Drying-induced variations in physico-chemical properties of amorphous pharmaceuticals and their impact on stability II: stability of a vaccine." Pharmaceutical Research 24 (2007): 715-727.
Adeel, Syeda Shazia, et al. "Stability of lyophilized measles vaccine: Stabilizers and Temperature parameters." Proceedings of the Pakistan Academy of Sciences. (2020)
Allmendinger, Andrea, et al. "Controlling ice nucleation during lyophilization: Process Optimization of vacuum-induced surface freezing." Processes 8.10 (2020): 1263
Allmendinger, Andrea, et al. "High-throughput viscosity measurement using capillary electrophoresis instrumentation and its application to protein formulation." Journal of pharmaceutical and biomedical analysis 99 (2014): 51-58
Allmendinger, Andrea, et al. "Sterile filtration of highly concentrated protein formulations: impact of protein concentration, formulation composition, and filter material." Journal of pharmaceutical sciences 104.10 (2015): 3319-3329
Ameri, Mahmoud, et al. "Human growth hormone delivery with a microneedle transdermal system: Preclinical formulation, stability, delivery and PK of therapeutically relevant doses." Pharmaceutics 6.2 (2014): 220-234.
Ameri, Mahmoud, Peter E. Daddona, and Yuh-Fun Maa. "Demonstrated solid-state stability of parathyroid hormone PTH (1–34) coated on a novel transdermal microprojection delivery system." Pharmaceutical research 26 (2009): 2454-2463.
Ameri, Mahmoud, Shelley C. Fan, and Yuh-Fun Maa. "Parathyroid hormone PTH (1-34) formulation that enables uniform coating on a novel transdermal microprojection delivery system." Pharmaceutical research 27 (2010): 303-313.
Ameri, Mahmoud, Xiaomei Wang, and Yuh‐Fun Maa. "Effect of irradiation on parathyroid hormone PTH (1–34) coated on a novel transdermal microprojection delivery system to produce a sterile product—adhesive compatibility." Journal of pharmaceutical sciences 99.4 (2010): 2123-2134.
Ameri, Mahmoud, Yi Ao, and Hayley Lewis. "Formulation approach that enables the coating of a stable influenza vaccine on a transdermal microneedle patch." AAPS PharmSciTech 22.5 (2021): 175.
Anaya, Juan. "Effects of Osmolytes on Amyloid-beta Protein Surface Activity and Membrane Interactions." (2013).
Anchordoquy, Thomas J., Taylor K. Armstrong, and Marion dC Molina. "Low molecular weight dextrans stabilize nonviral vectors during lyophilization at low osmolalities: concentrating suspensions by rehydration to reduced volumes." Journal of pharmaceutical sciences 94.6 (2005): 1226-1236.
Armstrong, Taylor K., and Thomas J. Anchordoquy. "Immobilization of nonviral vectors during the freezing step of lyophilization." Journal of pharmaceutical sciences 93.11 (2004): 2698-2709
Bai, Ling, et al. "Investigation of Excipients Impact on Polysorbate 80 Degradation in Biopharmaceutical Formulation Buffers." Journal of Pharmaceutical and Biomedical Analysis (2023): 115496
Bakaltcheva, Irina, et al. "Freeze-dried whole plasma: evaluating sucrose, trehalose, sorbitol, mannitol and glycine as stabilizers." Thrombosis research 120.1 (2007): 105-116
Basu, Pinaki, et al. "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 102.3 (2013): 852-865
Basu, Pinaki. Particles in therapeutic protein formulations–relevance to air-water and silicone oil-water interfaces. University of Colorado Denver, Anschutz Medical Campus, 2014
Bee, Jared S., et al. "Impact of time out of intended storage and freeze-thaw rates on the stability of adeno-associated virus 8 and 9." Journal of Pharmaceutical Sciences 111.5 (2022): 1346-1353
Bee, Jared S., et al. "Mechanistic studies and formulation mitigations of adeno-associated virus capsid rupture during freezing and thawing: mechanisms of freeze/thaw induced AAV rupture." Journal of Pharmaceutical Sciences 111.7 (2022): 1868-1878
Bensaid, Fethi, et al. "Mechanistic understanding of metal-catalyzed oxidation of polysorbate 80 and monoclonal antibody in biotherapeutic formulations." International Journal of Pharmaceutics 615 (2022): 121496
Betker, Jamie, et al. "Application of a ultra performance liquid chromatography method in the determination of DNA quality and stability." Journal of pharmaceutical sciences 101.3 (2012): 987-997
Bonhoeffer, Bastian, Arno Kwade, and Michael Juhnke. "Alternative manufacturing concepts for solid oral dosage forms from drug nanosuspensions using fluid dispensing and forced drying technology." Journal of pharmaceutical sciences 107.3 (2018): 909-921
Boucher, Virginie, et al. "MtPM25 is an atypical hydrophobic late embryogenesis‐abundant protein that dissociates cold and desiccation‐aggregated proteins." Plant, cell & environment 33.3 (2010): 418-430.
Burger, Jessica L., et al. "Stabilizing formulations for inhalable powders of live-attenuated measles virus vaccine." Journal of aerosol medicine and pulmonary drug delivery 21.1 (2008): 25-34.
Burger, Jessica Lynne. Stabilization of live attenuated measles virus vaccine in glassy matrices. Diss. University of Colorado at Boulder, 2009
Cape, Stephen P., et al. "Preparation of active proteins, vaccines and pharmaceuticals as fine powders using supercritical or near-critical fluids." Pharmaceutical Research 25 (2008): 1967-1990.
Carpenter, J., et al. "Measurement of T g in lyophilized protein and protein excipient mixtures by dynamic mechanical analysis." Journal of thermal analysis and calorimetry 95 (2009): 881-884
Chi, Eva Y., et al. "Roles of conformational stability and colloidal stability in the aggregation of recombinant human granulocyte colony‐stimulating factor." Protein Science 12.5 (2003): 903-913.
Chou, Danny K., et al. "Physical stability of albinterferon-α2b in aqueous solution: effects of conformational stability and colloidal stability on aggregation." Journal of pharmaceutical sciences 101.8 (2012): 2702-2719.
Chou, Danny Kochen. Mechanistic insights into physical and chemical stability of albumin fusion proteins in aqueous solution. University of Colorado Health Sciences Center, 2008
Cioni, Patrizia, Emilia Bramanti, and Giovanni B. Strambini. "Effects of sucrose on the internal dynamics of azurin." Biophysical journal 88.6 (2005): 4213-4222
Clavaud, Matthieu, et al. "Near-infrared spectroscopy to determine residual moisture in freeze-dried products: model generation by statistical design of experiments." Journal of Pharmaceutical Sciences 109.1 (2020): 719-729
Covi, Joseph A., and Steven C. Hand. "Energizing an invertebrate embryo: bafilomycin-dependent respiration and the metabolic cost of proton pumping by the V-ATPase." Physiological and Biochemical Zoology 80.4 (2007): 422-432.
Covi, Joseph A., W. Dale Treleaven, and Steven C. Hand. "V-ATPase inhibition prevents recovery from anoxia in Artemia franciscana embryos: quiescence signaling through dissipation of proton gradients." Journal of Experimental Biology 208.14 (2005): 2799-2808.
Covi, Joseph Antonio. V-ATPase expression and function in the brine shrimp, Artemia franciscana: role of proton gradients in anoxia-induced quiescence. Louisiana State University and Agricultural & Mechanical College, 2005.
Dahmana, Naoual, et al. "Reversible protein complexes as a promising avenue for the development of high concentration formulations of biologics." International Journal of Pharmaceutics 648 (2023): 123616.
Davies, Rupert Hugo. Luminescent assays for the assessment of metabolism and renal function: Towards a multianalyte biosensor. The University of Utah, 2005
dC Molina, Marion, et al. "The stability of lyophilized lipid/DNA complexes during prolonged storage." Journal of pharmaceutical sciences 93.9 (2004): 2259-2273.
Devineni, Dilip, et al. "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 88.2 (2014): 332-341.
Doshi, Nidhi, et al. "Evaluation of super refined™ polysorbate 20 with respect to polysorbate degradation, particle formation and protein stability." Journal of Pharmaceutical Sciences 109.10 (2020): 2986-2995
Doshi, Nidhi, Joelle Martin, and Anthony Tomlinson. "Improving prediction of free fatty acid particle formation in biopharmaceutical drug products: incorporating ester distribution during polysorbate 20 degradation." Molecular Pharmaceutics 17.11 (2020): 4354-4363
Doshi, Nidhi, Karen Rutherford, and Asil Najjar. "Dissolution of polysorbate 20 degradation related free fatty acid particles in intravenous bag solutions." Journal of Pharmaceutical Sciences 110.2 (2021): 687-692
Eads, Brian D., and Steven C. Hand. "Mitochondrial mRNA stability and polyadenylation during anoxia-induced quiescence in the brine shrimp Artemia franciscana." Journal of experimental biology 206.20 (2003): 3681-3692
Estey, Tia Brie. Protein instability associated with PLGA delivery systems and UV-induced protein oxidation. University of Colorado Health Sciences Center, 2006
Fish, Raphael, Jasper Lin, and Nidhi Doshi. "Impact of silicone oil on free fatty acid particle formation due to Polysorbate 20 degradation." Pharmaceutical Research 37 (2020): 1-15.
Garzon-Rodriguez, William, et al. "Optimizing storage stability of lyophilized recombinant human interleukin-11 with disaccharide/hydroxyethyl starch mixtures." Journal of pharmaceutical sciences 93.3 (2004): 684-696
Gefroh, Eva, et al. "Multipronged approach to managing beta‐glucan contaminants in the downstream process: control of raw materials and filtration with charge‐modified nylon 6, 6 membrane filters." Biotechnology Progress 29.3 (2013): 672-680.
Gill, Herman, et al. "The production, quality control, and characterization of ZED8, a CD8-specific 89 Zr-labeled immuno-PET clinical imaging agent." The AAPS Journal 22 (2020): 1-12.
Glover, Zephania Kwong, et al. "Physicochemical and biological impact of metal-catalyzed oxidation of IgG1 monoclonal antibodies and antibody-drug conjugates via reactive oxygen species." Mabs. Vol. 14. No. 1. Taylor & Francis, 2022.
Goins, Beth, Ande Bao, and William T. Phillips. "Techniques for loading technetium-99m and rhenium-186/188 radionuclides into preformed liposomes for diagnostic imaging and radionuclide therapy." Liposomes: Methods and Protocols (2017): 155-178
Gray, Gary M. "MECHANISM OF a-LIMIT DEXTRIN HYDROLYSIS BY INTESTINAL SUCRASE-ISOMALTASEl." Mechanisms of Saccharide Polymerization and Depolymerization (2012): 125
Grohganz, Holger, et al. "Classification of lyophilised mixtures using multivariate analysis of NIR spectra." European journal of pharmaceutics and biopharmaceutics 74.2 (2010): 406-412
Grohganz, Holger, et al. "Role of excipients in the quantification of water in lyophilised mixtures using NIR spectroscopy." Journal of pharmaceutical and biomedical analysis 49.4 (2009): 901-907
Haeuser, Christina, et al. "Be aggressive! Amorphous excipients enabling single-step freeze-drying of monoclonal antibody formulations." Pharmaceutics 11.11 (2019): 616.
Haeuser, Christina, et al. "Excipients for room temperature stable freeze-dried monoclonal antibody formulations." Journal of pharmaceutical sciences 109.1 (2020): 807-817.
Haeuser, Christina, et al. "Excipients for room temperature stable freeze-dried monoclonal antibody formulations." Journal of pharmaceutical sciences 109.1 (2020): 807-817.
Haeuser, Christina, et al. "Imaging techniques to characterize cake appearance of freeze-dried products." Journal of pharmaceutical sciences 107.11 (2018): 2810-2822.
Haeuser, Christina, et al. "Impact of dextran on thermal properties, product quality attributes, and monoclonal antibody stability in freeze-dried formulations." European Journal of Pharmaceutics and Biopharmaceutics 147 (2020): 45-56.
Hall, Barry G., Andreas Pikis, and John Thompson. "Evolution and biochemistry of family 4 glycosidases: implications for assigning enzyme function in sequence annotations." Molecular biology and evolution 26.11 (2009): 2487-2497.
Hofer, Markus, Gerhard Winter, and Julia Myschik. "Recombinant spider silk particles for controlled delivery of protein drugs." Biomaterials 33.5 (2012): 1554-1562
Hu, Gang, et al. "Physicochemical characterization of biological and synthetic forms of two lipid A-based TLR4 agonists." Heliyon 9.7 (2023).
Huang, Chi-Ting, et al. "Quantitation of protein particles in parenteral solutions using micro-flow imaging." Journal of pharmaceutical sciences 98.9 (2009): 3058-3071.
Jahn, Michael, et al. "Measuring lipolytic activity to support process improvements to manage lipase-mediated polysorbate degradation." Pharmaceutical Research 37 (2020): 1-13.
Jameel, Feroz, et al. "Development of freeze-dried biosynthetic Factor VIII: I. A case study in the optimization of formulation." Pharmaceutical Development and Technology 14.6 (2009): 687-697
Ji, Junyan A., et al. "Methionine, tryptophan, and histidine oxidation in a model protein, PTH: mechanisms and stabilization." Journal of pharmaceutical sciences 98.12 (2009): 4485-4500.
Kardorff, Markus, et al. "Cryoprotection in Human Mesenchymal Stromal/Stem Cells: Synergistic Impact of Urea and Glucose." Journal of Pharmaceutical Sciences 112.6 (2023): 1681-1686
Katayama, Derrick S. Towards a mechanistic understanding of pharmaceutical protein stabilization in solution and the solid state. University of Colorado Health Sciences Center, 2006.
Katayama, Derrick S., et al. "Characterization of amorphous solids with weak glass transitions using high ramp rate differential scanning calorimetry." Journal of pharmaceutical sciences 97.2 (2008): 1013-1024
Kim, Yong‐Sung, et al. "Effects of sucrose on conformational equilibria and fluctuations within the native‐state ensemble of proteins." Protein Science 12.6 (2003): 1252-1261
Kissmann, Julian Michael. The application of empirical phase diagrams to the biophysical characterization and stabilization of viral vaccine candidates. Diss. University of Kansas, 2010.
Kissmann, Julian, et al. "H1N1 influenza virus-like particles: physical degradation pathways and identification of stabilizers." Journal of pharmaceutical sciences 100.2 (2011): 634-645.
Kissmann, Julian, et al. "Stabilization of measles virus for vaccine formulation." Human vaccines 4.5 (2008): 350-359
Kovner, Daniel, et al. "Characterization of Recombinantly-Expressed Hydrolytic Enzymes from Chinese Hamster Ovary Cells: Identification of Host Cell Proteins that Degrade Polysorbate." Journal of Pharmaceutical Sciences 112.5 (2023): 1351-1363.
Krogstrup, Peter, et al. "Micropropagation of socotran fig, Dorstenia gigas schweinf. Ex Balf. F.—A threatened species, endemic to the island of Socotra, Yemen." In vitro cellular & developmental biology-plant 41 (2005): 81-86.
Kullmann, Daniel, et al. "Part II: Matrix based scaffold lyophilization facilitates processing as a prerequisite for an innovative packaging system." European Journal of Pharmaceutics and Biopharmaceutics 184 (2023): 262-273
Kumar, Lokesh, et al. "Optimizing the formulation and lyophilization process for a fragment antigen binding (Fab) protein using solid-state hydrogen–deuterium exchange mass spectrometry (ssHDX-MS)." Molecular Pharmaceutics 16.11 (2019): 4485-4495.
Kumru, Ozan S., et al. "Effects of aluminum-salt, CpG and emulsion adjuvants on the stability and immunogenicity of a virus-like particle displaying the SARS-CoV-2 receptor-binding domain (RBD)." Human Vaccines & Immunotherapeutics 19.2 (2023): 2264594.
Kumru, Ozan S., et al. "Physical characterization and stabilization of a lentiviral vector against adsorption and freeze-thaw." Journal of Pharmaceutical Sciences 107.11 (2018): 2764-2774
Kumru, Ozan S., et al. "Stabilization and formulation of a recombinant Human Cytomegalovirus vector for use as a candidate HIV-1 vaccine." Vaccine 37.44 (2019): 6696-6706.
Labrenz, Steven R. "Ester hydrolysis of polysorbate 80 in mAb drug product: evidence in support of the hypothesized risk after the observation of visible particulate in mAb formulations." Journal of pharmaceutical sciences 103.8 (2014): 2268-2277
Labrenz, Steven R. "Ester hydrolysis of polysorbate 80 in mAb drug product: evidence in support of the hypothesized risk after the observation of visible particulate in mAb formulations." Journal of pharmaceutical sciences 103.8 (2014): 2268-2277
Lavoie, R. Ashton, et al. "Enrichment of adeno‐associated virus serotype 5 full capsids by anion exchange chromatography with dual salt elution gradients." Biotechnology and Bioengineering (2023)
Lewis, Lavinia M., et al. "Characterizing the freeze–drying behavior of model protein formulations." Aaps Pharmscitech 11 (2010): 1580-1590
Liu, Lu, et al. "Freezing-induced perturbation of tertiary structure of a monoclonal antibody." Journal of pharmaceutical sciences 103.7 (2014): 1979-1986
Liu, Lu, et al. "The effects of excipients on protein aggregation during agitation: an interfacial shear rheology study." Journal of pharmaceutical sciences 102.8 (2013): 2460-2470.
Liu, Lu. Stress-induced aggregation of therapeutic proteins. Diss. University of Colorado at Denver, Anschutz Medical Campus. Health Sciences Library, 2007
Mamidi, Rao NVS, et al. "Pharmacokinetics, efficacy and toxicity of different pegylated liposomal doxorubicin formulations in preclinical models: is a conventional bioequivalence approach sufficient to ensure therapeutic equivalence of pegylated liposomal doxorubicin products?." Cancer chemotherapy and pharmacology 66 (2010): 1173-1184.
Matter, Anja, et al. "Variance between different light obscuration and flow imaging microscopy instruments and the impact of instrument calibration." Journal of Pharmaceutical Sciences 108.7 (2019): 2397-2405.
Menze, Michael A., and Steven C. Hand. "Caspase activity during cell stasis: avoidance of apoptosis in an invertebrate extremophile, Artemia franciscana." American Journal of Physiology-Regulatory, Integrative and Comparative Physiology 292.5 (2007): R2039-R2047.
Menze, Michael A., et al. "Mitochondrial permeability transition in the crustacean Artemia franciscana: absence of a calcium-regulated pore in the face of profound calcium storage." American Journal of Physiology-Regulatory, Integrative and Comparative Physiology 289.1 (2005): R68-R76.
Meyer, Jeffrey D., Rajiv Nayar, and Mark Cornell Manning. "Impact of bulking agents on the stability of a lyophilized monoclonal antibody." European journal of pharmaceutical sciences 38.1 (2009): 29-38
Meyer, Melody Michelle. The effects of cold temperature on Xylella fastidiosa-infected Vitis vinifera grapevines. University of California, Davis, 2010
Mohamad, Ahmad Mohamad Abdul-Fattah. Solid state stability of amorphous pharmaceuticals: Effects of process variations. University of Connecticut, 2006.
Moorthy, Balakrishnan S., et al. "Solid-state hydrogen–deuterium exchange mass spectrometry: correlation of deuterium uptake and long-term stability of lyophilized monoclonal antibody formulations." Molecular pharmaceutics 15.1 (2018): 1-11
Nakach, Mostafa, et al. "Mixing of Monoclonal Antibody Formulated Drug Substance Solutions in Square Disposable Vessels." Journal of Pharmaceutical Sciences 111.10 (2022): 2799-2813
Nesarikar, Vishwas V., and Munir N. Nassar. "Effect of cations and anions on glass transition temperatures in excipient solutions." Pharmaceutical development and technology 12.3 (2007): 259-264
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