Search Results - "Seibert, Kevin"

Surface-mediated spontaneous emulsification of the acylated peptide, semaglutide by Li, Qi, Tangry, Vasudev, Allen, David P, Seibert, Kevin D, Qian, Ken K, Wagner, Norman J

“…Acylated peptides composed of glucagon-like peptide-1 receptor agonists modified with a fatty acid side chain are an important class of therapeutics for type 2…”
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Quality by design of solid‐phase peptide/protein coupling reaction via mechanistic reaction kinetics modeling approach by Wang, Jingyao, Agrawal, Paridhi, Berglund, Mark R., Groh, Jennifer McClary, Kopach, Michael E., Seibert, Kevin D., Viswanath, Shekhar K.

“…Abstract The peptide coupling reaction is one of the most critical steps in the solid phase synthesis of therapeutic peptides/proteins. Improper reaction…”
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Definition of Design Spaces Using Mechanistic Models and Geometric Projections of Probability Maps by García-Muñoz, Salvador, Luciani, Carla V, Vaidyaraman, Shankar, Seibert, Kevin D

“…Following a model-centric strategy in the development of a manufacturing process for a new medicine empowers the simultaneous study of a large number of…”
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Modeling-Aided Scale-Up of High-Shear Rotor–Stator Wet Milling for Pharmaceutical Applications by Luciani, Carla V, Conder, Edward W, Seibert, Kevin D

“…This work describes a modeling-aided approach to scale-up high-shear rotor–stator wet milling processes for pharmaceutical applications. A population balance…”
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Kilogram-Scale GMP Manufacture of Tirzepatide Using a Hybrid SPPS/LPPS Approach with Continuous Manufacturing by Frederick, Michael O, Boyse, Raymond A, Braden, Timothy M, Calvin, Joel R, Campbell, Bradley M, Changi, Shujauddin M, Coffin, Stephanie R, Condon, Carmel, Gowran, Olivia, McClary Groh, Jennifer, Groskreutz, Stephen R, Harms, Zachary D, Humenik, Ashley A, Kallman, Neil J, Klitzing, Nicholas D, Kopach, Michael E, Kretsinger, Juliana K, Lambertus, Gordon R, Lampert, Jeffrey T, Maguire, Laura M, Moynihan, Humphrey A, Mullane, Nessa S, Murphy, John D, O’Mahony, Marie E, Richey, Rachel N, Seibert, Kevin D, Spencer, Richard D, Strege, Mark A, Tandogan, Nil, Torres Torres, Frank L, Tsukanov, Sergey V, Xia, Han

“…The large-scale manufacture of complex synthetic peptides is challenging due to many factors such as manufacturing risk (including failed product…”
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Mechanistic Study of Diketopiperazine Formation during Solid-Phase Peptide Synthesis of Tirzepatide by Wang, Jingyao, Berglund, Mark R., Braden, Timothy, Embry, Matthew C., Johnson, Martin D., Groskreutz, Stephen R., Sayyed, Fareed Bhasha, Tsukanov, Sergey Vladimirovich, White, Timothy D., Jalan, Ankur, Seibert, Kevin D., Kopach, Michael E.

“…This study focused on investigating diketopiperazine (DKP) and the formation of associated double-amino-acid deletion impurities during linear solid-phase…”
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Synthesis, Optimization, and Large-Scale Preparation of the Low-Dose Central Nervous System-Penetrant BACE1 Inhibitor LY3202626 via a [3 + 2] Nitrone Cycloaddition by Garcia-Losada, Pablo, DeBaillie, Amy C, Eugenio de Diego, Jose, Green, Steven J, Hansen, Marvin M, Jaramillo, Carlos, Johnson, Matt, Kaoudi, Talbi, Li, Jiuyuan, Lindsay-Scott, Peter J, Mateos, Carlos, Mergott, Dustin J, Rincon, Juan Antonio, Rothhaar, Roger R, Seibert, Kevin D, Watson, Brian M, Winneroski, Leonard L, Gangula, Srinivas, Jing, Dajiang, Sun, Hao, Zhang, Lei, Frederick, Michael O

“…Herein we report a summary of the synthetic development of LY3202626 from the initial discovery route to a final route that was scaled to make 150 kg. Key…”
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The Enabling Technologies Consortium (ETC): Fostering Precompetitive Collaborations on New Enabling Technologies for Pharmaceutical Research and Development by Welch, Christopher J, Faul, Margaret M, Tummala, Srinivas, Papageorgiou, Charles D, Hicks, Frederick, Hawkins, Joel M, Thomson, Nicholas, Cote, Aaron, Bordawekar, Shailendra, Wittenberger, Steven J, Laffan, David, Purdie, Mark, Boulas, Pierre, Irdam, Erwin, Horspool, Keith, Yang, Bing-Shiou, Tom, Jean, Fernandez, Paul, Ferretti, Antonio, May, Scott, Seibert, Kevin, Wells, Kenneth, McKeown, Rahn

“…The creation of the Enabling Technologies Consortium (ETC) is described. The ETC fosters precompetitive collaborations aimed at the development and evaluation…”
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Case Studies in the Applicability of Drug Substance Design Spaces Developed on the Laboratory Scale to Commercial Manufacturing by Thomson, Nicholas M, Seibert, Kevin D, Tummala, Srinivas, Bordawekar, Shailendra, Kiesman, William F, Irdam, Erwin A, Phenix, Brian, Kumke, Daniel

“…A number of strategies have been employed within the pharmaceutical industry in order to mitigate the risk of applying design space boundaries developed on the…”
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Case Studies in the Development of Drug Substance Control Strategies by Thomson, Nicholas M, Singer, Robert, Seibert, Kevin D, Luciani, Carla V, Srivastava, Sushil, Kiesman, William F, Irdam, Erwin A, Lepore, John V, Schenck, Luke

“…A series of case histories from IQ consortium member companies are presented in order to exemplify many of the different elements of drug substance control…”
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Unit Operations Characterization Using Historical Manufacturing Performance by Mitchell, Jerry D, Abhinava, Kumar, Griffiths, Kristi L, McGarvey, Bernard, Seibert, Kevin D, Sethuraman, Shanthi

“…Collecting unit operation performance data on manufacturing processes has many benefits. Besides assessing the health of assets, the data can also be analyzed…”
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Liquid Phase Peptide Synthesis via One‐Pot Nanostar Sieving (PEPSTAR) by Yeo, Jet, Peeva, Ludmila, Chung, Seoyeon, Gaffney, Piers, Kim, Daeok, Luciani, Carla, Tsukanov, Sergey, Seibert, Kevin, Kopach, Michael, Albericio, Fernando, Livingston, Andrew

“…Herein, a one‐pot liquid phase peptide synthesis featuring iterative addition of amino acids to a “nanostar” support, with organic solvent nanofiltration (OSN)…”
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Effect of Hydrodynamic and Magnetic Stabilization on Fluidized-Bed Adsorption by Seibert, Kevin D., Burns, Mark A.

“…Direct fermentation broth processing using fluidized beds is extremely advantageous due to the low operating pressure drop of the device and the ability of the…”
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Simulation of structural phenomena in mixed-particle fluidized beds by Seibert, Kevin D., Burns, Mark A.

“…A statistical mechanical simulation was developed and used to predict the macroscopic and microscopic behavior of fluidized beds. In particular, the model was…”
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Part 3: Enhanced Approaches to the Development of the Control Strategy and its Implementation in the Manufacturing Process Description by Popkin, Matt E., Omer, Batool Ahmed, Seibert, Kevin D., Luciani, Carla V., Srivastava, Sushil, Hobson, Lindsay, Lepore, John V.

“…A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced Quality by…”
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Liquid Phase Peptide Synthesis via One‐Pot Nanostar Sieving (PEPSTAR) by Yeo, Jet, Peeva, Ludmila, Chung, Seoyeon, Gaffney, Piers, Kim, Daeok, Luciani, Carla, Tsukanov, Sergey, Seibert, Kevin, Kopach, Michael, Albericio, Fernando, Livingston, Andrew

“…Herein, a one‐pot liquid phase peptide synthesis featuring iterative addition of amino acids to a “nanostar” support, with organic solvent nanofiltration (OSN)…”
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The Delivery of Flexibility from the Application of QbD to API Development by Popkin, Matt E., Borman, Phil J., Omer, Batool Ahmed, Seibert, Kevin D., Srivastava, Sushil, Lepore, John V., Hobson, Lindsay, Donaubauer, John, Curran, Timothy, Ide, Nathan, Tymonko, Steven, Looker, Adam, Kallemeyn, Jeffrey M.

“…This paper by IQ consortium member companies will describe how the application of the ICH Q11 vision for enhanced QbD development can lead to flexibility…”
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The Use of Routine Process Capability for the Determination of Process Parameter Criticality in Small-molecule API Synthesis by Seibert, Kevin D., Sethuraman, Shanthi, Mitchell, Jerry D., Griffiths, Kristi L., McGarvey, Bernard

“…During the development of a pharmaceutical chemical process, it is vital to establish a control strategy that will ensure the process performance and fitness…”
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Reduction of Particle Size of Drug Substance for Low‐Dose Drug Products by Burcham, Christopher L, Collins, Paul C, Jarmer, Daniel J, Seibert, Kevin D

“…This chapter contains sections titled: Introduction Reduction of Particle Size of Drug Substance by Milling Technologies Reduction of Particle Size of Drug…”
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The effect of stabilization on fluidized bed adsorption by Seibert, Kevin Dale

“…The focus of this project was to study fluidized beds from a particulate level. Using concepts from statistical mechanics, we have simulated fluidized bed…”
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