Search Results - "Rogstad, Sarah"

Multi-Attribute Method for Quality Control of Therapeutic Proteins by Rogstad, Sarah, Yan, Haoheng, Wang, Xiaoshi, Powers, David, Brorson, Kurt, Damdinsuren, Bazarragchaa, Lee, Sau

“…Recent advances in high resolution mass spectrometry (MS) instrumentation and semi-automated software have led to a push toward the use of MS-based methods for…”
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Improved Precision of Proteomic Measurements in Immunoprecipitation Based Purifications Using Relative Quantitation by Rogstad, Sarah M, Sorkina, Tatiana, Sorkin, Alexander, Wu, Christine C

“…Mass spectrometry coupled immunoprecipitation (MS-IP) studies are useful in identifying and quantitating potential binding partners of a target protein…”
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Comparison of Traditional 2-AB Fluorescence LC-MS/MS and Automated LC-MS for the Comparative Glycan Analysis of Monoclonal Antibodies by Schiel, John E, Rogstad, Sarah M, Boyne, 2nd, Michael T

“…Monoclonal antibody therapeutics are a heterogeneous mixture of glycoforms. Multiple methods exist for defining the glycan composition and relative abundance…”
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The ELISA Detectability and Potency of Pegfilgrastim Decrease in Physiological Conditions: Key Roles for Aggregation and Individual Variability by Xie, Tao, Fang, Hui, Ouyang, Weiming, Angart, Phillip, Chiang, Meng-Jung, Bhirde, Ashwinkumar A., Sheikh, Faruk, Lynch, Patrick, Shah, Ankit B., Patil, Sharadrao M., Chen, Kang, Shen, Meiyu, Agarabi, Cyrus, Donnelly, Raymond P., Brorson, Kurt, Schrieber, Sarah J., Howard, Kristina E., Rogstad, Sarah M., Frucht, David M.

“…PEGylated recombinant human granulocyte colony stimulating factor (pegfilgrastim) is used clinically to accelerate immune reconstitution following chemotherapy…”
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An etanercept O-glycovariant with enhanced potency by Biel, Thomas G., Faison, Talia, Matthews, Alicia M., Zou, Guozhang, Ortega-Rodriguez, Uriel, Pegues, Melissa A., Azer, Nicole, Gomez, Fabiola, Johnson, Sarah, Rogstad, Sarah, Chen, Kang, Xie, Hang, Agarabi, Cyrus, Rao, V. Ashutosh, Ju, Tongzhong

“…Most therapeutic proteins are glycosylated with N-glycans and/or O-glycans. N-glycans on therapeutic proteins have been extensively studied for their control…”
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The Use of Mass Spectrometry in Therapeutic Protein Biologics License Applications: A Retrospective Review Revisited by Mans, Jamie, Oyugi, Mercy, Asmelash, Bethel, Sommers, Cynthia, Rogstad, Sarah

“…Biologic license applications (BLAs) for 93 therapeutic proteins approved between 2016 and 2020 were analyzed for use of mass spectrometry (MS) as a follow up…”
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Method validation and new peak detection for the liquid chromatography-mass spectrometry multi-attribute method by Oyugi, Mercy, Wang, Xiaoshi, Yang, Xiangkun, Wu, Di, Rogstad, Sarah

“…The multi-attribute method (MAM) is a liquid chromatography-mass spectrometry (LC-MS) peptide mapping technique that has been proposed as a replacement for…”
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A Retrospective Evaluation of the Use of Mass Spectrometry in FDA Biologics License Applications by Rogstad, Sarah, Faustino, Anneliese, Ruth, Ashley, Keire, David, Boyne, Michael, Park, Jun

“…The characterization sections of biologics license applications (BLAs) approved by the United States Food and Drug Administration (FDA) between 2000 and 2015…”
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The role of mass spectrometry in the characterization of biologic protein products by Rathore, Deepali, Faustino, Anneliese, Schiel, John, Pang, Eric, Boyne, Michael, Rogstad, Sarah

“…Mass spectrometry (MS) is widely used in the characterization of biomolecules including peptide and protein therapeutics. These biotechnology products have…”
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Assessment of monoclonal antibody glycosylation: a comparative study using HRMS, NMR, and HILIC-FLD by Shipman, Joshua, Karfunkle, Michael, Zhu, Hongbin, Zhuo, You, Chen, Kang, Patabandige, Milani, Wu, Di, Oyugi, Mercy, Kerr, Richard, Yang, Kui, Rogstad, Sarah

“…Monoclonal antibodies (mAbs) represent the largest class of therapeutic protein drug products. mAb glycosylation produces a heterogeneous, analytically…”
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An ICP-MS platform for metal content assessment of cell culture media and evaluation of spikes in metal concentration on the quality of an IgG3:κ monoclonal antibody during production by Mohammad, Adil, Agarabi, Cyrus, Rogstad, Sarah, DiCioccio, Elizabeth, Brorson, Kurt, Ashraf, Muhammad, Faustino, Patrick J., Madhavarao, Chikkathur N.

“…•An ICP-MS methodology to determine bulk, minor and trace metal content (0.05 ppb–500 ppb) of mammalian cell culture media.•An advanced autodilution platform…”
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Stability of the Human Plasma Proteome to Pre-analytical Variability as Assessed by an Aptamer-Based Approach by Daniels, Jaclyn R, Cao, Zhijun, Maisha, Mackean, Schnackenberg, Laura K, Sun, Jinchun, Pence, Lisa, Schmitt, Thomas C, Kamlage, Beate, Rogstad, Sarah, Beger, Richard D, Yu, Li-Rong

“…Variable processing and storage of whole blood and/or plasma are potential confounders in biomarker development and clinical assays. The goal of the study was…”
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New Peak Detection Performance Metrics from the MAM Consortium Interlaboratory Study by Mouchahoir, Trina, Schiel, John E, Rogers, Rich, Heckert, Alan, Place, Benjamin J, Ammerman, Aaron, Li, Xiaoxiao, Robinson, Tom, Schmidt, Brian, Chumsae, Chris M, Li, Xinbi, Manuilov, Anton V, Yan, Bo, Staples, Gregory O, Ren, Da, Veach, Alexander J, Wang, Dongdong, Yared, Wael, Sosic, Zoran, Wang, Yan, Zang, Li, Leone, Anthony M, Liu, Peiran, Ludwig, Richard, Tao, Li, Wu, Wei, Cansizoglu, Ahmet, Hanneman, Andrew, Adams, Greg W, Perdivara, Irina, Walker, Hunter, Wilson, Margo, Brandenburg, Arnd, DeGraan-Weber, Nick, Gotta, Stefano, Shambaugh, Joe, Alvarez, Melissa, Yu, X. Christopher, Cao, Li, Shao, Chun, Mahan, Andrew, Nanda, Hirsh, Nields, Kristen, Nightlinger, Nancy, Barysz, Helena Maria, Jahn, Michael, Niu, Ben, Wang, Jihong, Leo, Gabriella, Sepe, Nunzio, Liu, Yan-Hui, Patel, Bhumit A, Richardson, Douglas, Wang, Yi, Tizabi, Daniela, Borisov, Oleg V, Lu, Yali, Maynard, Ernest L, Gruhler, Albrecht, Haselmann, Kim F, Krogh, Thomas N, Sönksen, Carsten P, Letarte, Simon, Shen, Sean, Boggio, Kristin, Johnson, Keith, Ni, Wenqin, Patel, Himakshi, Ripley, David, Rouse, Jason C, Zhang, Ying, Daniels, Carly, Dawdy, Andrew, Friese, Olga, Powers, Thomas W, Sperry, Justin B, Woods, Josh, Carlson, Eric, Sen, K. Ilker, Skilton, St John, Busch, Michelle, Lund, Anders, Stapels, Martha, Guo, Xu, Heidelberger, Sibylle, Kaluarachchi, Harini, McCarthy, Sean, Kim, John, Zhen, Jing, Zhou, Ying, Rogstad, Sarah, Wang, Xiaoshi, Fang, Jing, Chen, Weibin, Yu, Ying Qing, Hoogerheide, John G, Scott, Rebecca, Yuan, Hua

“…The Multi-Attribute Method (MAM) Consortium was initially formed as a venue to harmonize best practices, share experiences, and generate innovative…”
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An Integrated Analysis of Metabolites, Peptides, and Inflammation Biomarkers for Assessment of Preanalytical Variability of Human Plasma by Cao, Zhijun, Kamlage, Beate, Wagner-Golbs, Antje, Maisha, Mackean, Sun, Jinchun, Schnackenberg, Laura K, Pence, Lisa, Schmitt, Thomas C, Daniels, Jaclyn R, Rogstad, Sarah, Beger, Richard D, Yu, Li-Rong

“…Discrepancies in blood sample collection and processing could have a significant impact on levels of metabolites, peptides, and protein biomarkers of…”
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Modern analytics for synthetically derived complex drug substances: NMR, AFFF–MALS, and MS tests for glatiramer acetate by Rogstad, Sarah, Pang, Eric, Sommers, Cynthia, Hu, Meng, Jiang, Xiaohui, Keire, David A., Boyne, Michael T.

“…Glatiramer acetate (GA) is a mixture of synthetic copolymers consisting of four amino acids (glutamic acid, lysine, alanine, and tyrosine) with a labeled…”
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Attribute Analytics Performance Metrics from the MAM Consortium Interlaboratory Study by Mouchahoir, Trina, Schiel, John E., Rogers, Rich, Heckert, Alan, Place, Benjamin J., Ammerman, Aaron, Li, Xiaoxiao, Robinson, Tom, Schmidt, Brian, Chumsae, Chris M., Li, Xinbi, Manuilov, Anton V., Yan, Bo, Staples, Gregory O., Ren, Da, Veach, Alexander J., Wang, Dongdong, Yared, Wael, Sosic, Zoran, Wang, Yan, Zang, Li, Leone, Anthony M., Liu, Peiran, Ludwig, Richard, Tao, Li, Wu, Wei, Cansizoglu, Ahmet, Hanneman, Andrew, Adams, Greg W., Perdivara, Irina, Walker, Hunter, Wilson, Margo, Brandenburg, Arnd, DeGraan-Weber, Nick, Gotta, Stefano, Shambaugh, Joe, Alvarez, Melissa, Yu, X. Christopher, Cao, Li, Shao, Chun, Mahan, Andrew, Nanda, Hirsh, Nields, Kristen, Nightlinger, Nancy, Niu, Ben, Wang, Jihong, Xu, Wei, Leo, Gabriella, Sepe, Nunzio, Liu, Yan-Hui, Patel, Bhumit A., Richardson, Douglas, Wang, Yi, Tizabi, Daniela, Borisov, Oleg V., Lu, Yali, Maynard, Ernest L., Gruhler, Albrecht, Haselmann, Kim F., Krogh, Thomas N., Sönksen, Carsten P., Letarte, Simon, Shen, Sean, Boggio, Kristin, Johnson, Keith, Ni, Wenqin, Patel, Himakshi, Ripley, David, Rouse, Jason C., Zhang, Ying, Daniels, Carly, Dawdy, Andrew, Friese, Olga, Powers, Thomas W., Sperry, Justin B., Woods, Josh, Carlson, Eric, Sen, K. Ilker, Skilton, St John, Busch, Michelle, Lund, Anders, Stapels, Martha, Guo, Xu, Heidelberger, Sibylle, Kaluarachchi, Harini, McCarthy, Sean, Kim, John, Zhen, Jing, Zhou, Ying, Rogstad, Sarah, Wang, Xiaoshi, Fang, Jing, Chen, Weibin, Yu, Ying Qing, Hoogerheide, John G., Scott, Rebecca, Yuan, Hua

“…The multi-attribute method (MAM) was conceived as a single assay to potentially replace multiple single-attribute assays that have long been used in process…”
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Exploring the linkage between cell culture process parameters and downstream processing utilizing a plackett‐burman design for a model monoclonal antibody by Agarabi, Cyrus D., Chavez, Brittany K., Lute, Scott C., Read, Erik K., Rogstad, Sarah, Awotwe‐Otoo, David, Brown, Matthew R., Boyne, Michael T., Brorson, Kurt A.

“…Linkage of upstream cell culture with downstream processing and purification is an aspect of Quality by Design crucial for efficient and consistent production…”
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Circulating biomarkers of neurotoxicity: Proteomics approach reveals fluidic endpoints of central nervous system toxicity in a rodent model of neurotoxicity by Imam, Syed, He, Zhen, Rogstad, Sarah, Burks, Susan, Raymick, James, Robinson, Bonnie, Cuevas, Elvis, Sarkar, Sumit, Law, Charles, Hanig, Joseph, Herr, David, MacMillan, Denise, Smith, Aaron, Liachenko, Serguei, O'Callaghan, James, Somps, Christopher, Pardo, Ingrid, Pierson, Jennifer B., Roberts, Ruth, Gong, Binsheng, Tong, Weida, Aschner, Michael, Kallman, Mary Jeanne, Ferguson, Sherry, Paule, Merle, Slikker, William

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2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity) by Neubert, Hendrik, Olah, Timothy, Lee, Anita, Fraser, Stephanie, Dodge, Robert, Laterza, Omar, Szapacs, Matthew, Alley, Stephen C, Saad, Ola M, Amur, Shashi, Chen, Linzhi, Cherry, Elana, Cho, Seongeun (Julia), Cludts, Isabelle, Donato, Lorella Di, Edmison, Anna, Ferrari, Luca, Garofolo, Fabio, Haidar, Sam, Hopper, Shirley, Hottenstein, Scott, Ishii-Watabe, Akiko, Kassim, Sean, Kurki, Pekka, Lima Santos, Gustavo Mendes, Miscoria, Gilles, Palandra, Joe, Pedras-Vasconcelos, João, Piccoli, Steven, Rogstad, Sarah, Saito, Yoshiro, Savoie, Natasha, Sikorski, Timothy, Spitz, Susan, Staelens, Ludovicus, Verthelyi, Daniela, Vinter, Stephen, Wadhwa, Meenu, Wang, Yow-Ming, Welink, Jan, Weng, Naidong, Whale, Emma, Woolf, Eric, Wu, Jiang, Yan, Haoheng, Yu, Hongbin, Zhou, Shaolian

“…The 2018 12 Workshop on Recent Issues in Bioanalysis took place in Philadelphia, PA, USA on April 9-13, 2018 with an attendance of over 900 representatives…”
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Marketplace Analysis of Conjugated Estrogens: Determining the Consistently Present Steroidal Content with LC-MS by Levy, Michaella J., Boyne, Michael T., Rogstad, Sarah, Skanchy, David J., Jiang, Xiaohui, Geerlof-Vidavsky, Ilan

“…Conjugated estrogens purified from pregnant mares urine has been used as estrogen hormone replacement therapy since 1942. Previously, methods were proposed to…”
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