Search Results - "Cao, Shawn"

Characterization of Subvisible Particles in Biotherapeutic Prefilled Syringes: The Role of Polysorbate and Protein on the Formation of Silicone Oil and Protein Subvisible Particles After Drop Shock by Jiao, Nancy, Barnett, Gregory V, Christian, Twinkle R, Narhi, Linda O, Joh, Nathan H, Joubert, Marisa K, Cao, Shawn

“…Subvisible particles (SbVPs) are a critical quality attribute for biotherapeutics. Particle content in prefilled syringes (PFSs) of a biotherapeutic can…”
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Analytical and Functional Similarity of the Biosimilar Candidate ABP 654 to Ustekinumab Reference Product by Cantin, Greg, Liu, Qian, Shah, Bhavana, Kuhns, Scott, Wikström, Mats, Cao, Shawn, Liu, Jennifer

“…Background and Objective ABP 654 is a proposed biosimilar to ustekinumab reference product (RP), a human immunoglobulin isotype class G subclass 1 kappa…”
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A critical review of analytical methods for subvisible and visible particles by Narhi, Linda O, Jiang, Yijia, Cao, Shawn, Benedek, Kalman, Shnek, Deborah

“…The subvisible and visible particles present in a solution are often classified based on size, and are quantified by the actual number of particles present…”
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Separation and characterization of protein aggregates and particles by field flow fractionation by Cao, Shawn, Pollastrini, Joey, Jiang, Yijia

“…Field flow fractionation (FFF) is a technique that holds great promise for the analysis and characterization of protein aggregates and particles, due to its…”
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Analytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product by Seo, Neungseon, Guan, Xiaoyan, Wang, Tian, Chung, Hyo S. Helen, Wikström, Mats, Padaki, Rupa, Kalenian, Kevin, Kuhns, Scott, Matthies, Kelli, Crouse-Zeineddini, Jill, Wong, Helen Y., Ng, Michael, Foltz, Ian N., Cao, Shawn, Liu, Jennifer

“…Introduction ABP 938 is being developed as a biosimilar candidate to aflibercept reference product (RP), a biologic used for certain angiogenic eye disorders…”
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Ion‐specific modulation of protein interactions: Anion‐induced, reversible oligomerization of a fusion protein by Gokarn, Yatin R., Fesinmeyer, R. Matthew, Saluja, Atul, Cao, Shawn, Dankberg, Jane, Goetze, Andrew, Jr, Richard L. Remmele, Narhi, Linda O., Brems, David N.

“…Ions can significantly modulate the solution interactions of proteins. We aim to demonstrate that the salt‐dependent reversible heptamerization of a fusion…”
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Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab by Liu, Jennifer, Eris, Tamer, Li, Cynthia, Cao, Shawn, Kuhns, Scott

“…Background ABP 501 is being developed as a biosimilar to adalimumab. Comprehensive comparative analytical characterization studies have been conducted and…”
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Characterizing Reversible Protein Association at Moderately High Concentration Via Composition-Gradient Static Light Scattering by Some, Daniel, Pollastrini, Joseph, Cao, Shawn

“…Analysis of weakly self-associating macromolecules at concentrations beyond a few g/L is challenging on account of the confounding effect of thermodynamic…”
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In Situ Quantification of Polysorbate in Pharmaceutical Samples of Therapeutic Proteins by Hydrodynamic Profiling by NMR Spectroscopy by Poppe, Leszek, Knutson, Nicholas, Cao, Shawn, Wikström, Mats

“…Polysorbates are nonionic surfactants often used at variable levels in various formulations of protein therapeutics. Their quantification in pharmaceutical…”
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Industry Perspective on the use and Characterization of Polysorbates for Biopharmaceutical Products Part 1: Survey Report on Current State and Common Practices for Handling and Control of Polysorbates by Wuchner, Klaus, Yi, Linda, Chery, Cyrille, Nikels, Felix, Junge, Friederike, Crotts, George, Rinaldi, Gianluca, Starkey, Jason A, Bechtold-Peters, Karoline, Shuman, Melissa, Leiss, Michael, Jahn, Michael, Garidel, Patrick, de Ruiter, Rien, Richer, Sarah M, Cao, Shawn, Peuker, Sebastian, Huille, Sylvain, Wang, Tingting, Le Brun, Virginie

“…Polysorbates (PS) are widely used as a stabilizer in biopharmaceutical products. Industry practices on various aspects of PS are presented in this part 1…”
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Analytical and functional similarity of Amgen biosimilar ABP 215 to bevacizumab by Seo, Neungseon, Polozova, Alla, Zhang, Mingxuan, Yates, Zachary, Cao, Shawn, Li, Huimin, Kuhns, Scott, Maher, Gwendolyn, McBride, Helen J, Liu, Jennifer

“…ABP 215 is a biosimilar product to bevacizumab. Bevacizumab acts by binding to vascular endothelial growth factor A, inhibiting endothelial cell proliferation…”
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Industry Perspective on the Use and Characterization of Polysorbates for Biopharmaceutical Products Part 2: Survey Report on Control Strategy Preparing for the Future by Wuchner, Klaus, Yi, Linda, Chery, Cyrille, Nikels, Felix, Junge, Friederike, Crotts, George, Rinaldi, Gianluca, Starkey, Jason A, Bechtold-Peters, Karoline, Shuman, Melissa, Leiss, Michael, Jahn, Michael, Garidel, Patrick, de Ruiter, Rien, Richer, Sarah M, Cao, Shawn, Peuker, Sebastian, Huille, Sylvain, Wang, Tingting, Brun, Virginie Le

“…Polysorbate (PS) 20 and 80 are the main surfactants used to stabilize biopharmaceutical products. Industry practices on various aspects of PS based on a…”
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Analytical and functional similarity of biosimilar ABP 798 with rituximab reference product by Seo, Neungseon, Huang, Zhe, Kuhns, Scott, Sweet, Heather, Cao, Shawn, Wikström, Mats, Liu, Jennifer

“…ABP 798 is a biosimilar candidate to rituximab reference product (RP). This comprehensive analytical similarity assessment was designed to assess the…”
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Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference Product by Hutterer, Katariina M., Ip, Anna, Kuhns, Scott, Cao, Shawn, Wikström, Mats, Liu, Jennifer

“…Background ABP 959 is one of the first proposed biosimilars to eculizumab reference product (RP), a recombinant IgG2/4 Ƙ monoclonal antibody (mAb) that binds…”
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Silicone Oil Particles in Prefilled Syringes With Human Monoclonal Antibody, Representative of Real-World Drug Products, Did Not Increase Immunogenicity in In Vivo and In Vitro Model Systems by Joh, Nathan H, Thomas, Lisa, Christian, Twinkle R, Verlinsky, Alla, Jiao, Nancy, Allotta, Nilo, Jawa, Vibha, Cao, Shawn, Narhi, Linda O, Joubert, Marisa K

“…Silicone oil is a lubricant for prefilled syringes (PFS), a common primary container for biotherapeutics. Silicone oil particles (SiOP) shed from PFS are a…”
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Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products by Saggu, Miguel, Bou-Assaf, George M, Bucher, Reinhard, Budyak, Ivan L, Buecheler, Jakob, Cao, Shawn, Groenning, Minna, Khan, Emon, Kwok, Stanley C, Minocha, Shalini, Pisupati, Karthik, Radhakrishnan, Vinay, Videbæk, Nicoline, Yang, Dennis T, Zhang, Bin, Narhi, Linda O

“…Silicone oil is a commonly used lubricant in pre-filled syringes (PFSs) and can migrate over time into solution in the form of silicone oil particles (SiOPs)…”
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A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products by Hubert, Mario, Yang, Dennis T, Kwok, Stanley C, Rios, Anacelia, Das, Tapan K, Patel, Ankit, Wuchner, Klaus, Antochshuk, Valentyn, Junge, Friederike, Bou-Assaf, George M, Cao, Shawn, Saggu, Miguel, Montrond, Luis, Afonina, Nataliya, Kolhe, Parag, Loladze, Vakhtang, Narhi, Linda

“…One of the major product quality challenges for injectable biologics is controlling the amount of protein aggregates and particles present in the final drug…”
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Subvisible (2–100 μm) particle analysis during biotherapeutic drug product development: Part 2, experience with the application of subvisible particle analysis by Corvari, Vincent, Narhi, Linda O., Spitznagel, Thomas M., Afonina, Nataliya, Cao, Shawn, Cash, Patricia, Cecchini, Irene, DeFelippis, Michael R., Garidel, Patrick, Herre, Andrea, Koulov, Atanas V., Lubiniecki, Tony, Mahler, Hanns-Christian, Mangiagalli, Paolo, Nesta, Douglas, Perez-Ramirez, Bernardo, Polozova, Alla, Rossi, Mara, Schmidt, Roland, Simler, Robert, Singh, Satish, Weiskopf, Andrew, Wuchner, Klaus

“…Measurement and characterization of subvisible particles (including proteinaceous and non-proteinaceous particulate matter) is an important aspect of the…”
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Classification of glass particles in parenteral product vials by visual, microscopic, and spectroscopic methods by Li, Gary Guiyang, Cao, Shawn, Jiao, Nancy, Wen, Zai-Qing

“…Glass vials have been used as primary containers for parenteral drugs including biopharmaceuticals. Different types of glass-related particles, although in low…”
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Monitoring ceramic hydroxyapatite media degradation using dynamic image analysis and uniaxial confined bulk compression by Kaltenbrunner, Oliver, Cao, Shawn, Freydell, Esteban, Keener, Nick, Zhu, Li, Jiao, Nancy, Williamson, Brian, Snyder, Mark A., Cummings, Larry J.

“…Ceramic hydroxyapatite (CHT) is a multimodal chromatographic medium widely used in the pharmaceutical industry for the purification of biomolecules. CHT is a…”
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