Publications by authors named "David Semin"

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Discoloration source and control of a biotechnological drug product manufactured using a high titer production process.
Jian Liu, Zhongqi Zhang, Alla Polozova, Becky Chan, Nimesh Savjani, David J Semin

J Pharm Sci· October 2025

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Advancing the implementation of innovative analytical technologies in pharmaceutical manufacturing-Some regulatory considerations.
Ting Wang, Nina S Cauchon, J Paul Kirwan, Marisa K Joubert, Marquerita Algorri, David J Semin

J Pharm Sci· February 2025

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Critical Aspects of pH Measurement for Bacteriostatic Water for Injection.
Jinbo Hu, Ali Kyad, Kathleen Burke, Lisa Sakiyama, Carolina Moraes De Souza, David Semin

J Pharm Sci· August 2023

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Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components.
Robin Wagner, Peter Masatani, Dana Grace, Gianpiero Torraca, Stephanie Moore, David Semin

PDA J Pharm Sci Technol· April 2023

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Investigation of a failed DNA assay leads to identification of an unexpected contaminant in a commonly used chromatography buffer.
Scott T Kuhns, David J Semin, Neil P Soice, Andy Kappes, H Edward Wong

Biotechnol Prog· March 2023

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Observation and Mitigation of Lamellar Silica Particles Formed in Pharmaceutical Products Packaged in Glass Vials.
Yasser Nashed-Samuel, Jeremy Gastwirt, Ruchi B Kotia, Stephanie Moore, Peter Masatani, David J Semin

J Pharm Sci· December 2022

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State-of-the-art and emerging trends in analytical approaches to pharmaceutical-product commercialization.
Laura E Blue, Xiaoyan Guan, Marisa K Joubert, Scott T Kuhns, Stephanie Moore, David J Semin

Curr Opin Biotechnol· December 2022

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Characterization of a Novel Particle in a Pharmaceutical Drug Product.
Stephanie Moore, Peter Masatani, Yasser Nashed-Samuel, Gianpiero Torraca, Michael Akers, David Semin

PDA J Pharm Sci Technol· October 2022

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Recommendation of Single Time Point Leachables Testing for Lyophilized Biotechnology Products Stored in Rubber Stoppered Glass Vial Systems.
Alejandra Gallegos, Jian Liu, Michael Ronk, Li Qi, Kim Li, David Semin

J Pharm Sci· June 2022

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Non-targeted characterization of attributes affecting antibody-FcγRIIIa V158 (CD16a) binding via online affinity chromatography-mass spectrometry.
Daniel W Woodall, Thomas M Dillon, Kevin Kalenian, Rupa Padaki, Scott Kuhns, David J Semin

MAbs· March 2022

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Observation and Mitigation of Leachables from Non-Product Contact Materials in Electromechanical Delivery Devices for Biotechnology Products.
Jian Liu, Michael Ronk, Yanxin Luo, Jette Wypych, Zhongqi Zhang, David Semin

J Pharm Sci· December 2021

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Identification of critical chemical modifications and paratope mapping by size exclusion chromatography of stressed antibody-target complexes.
Pavel Bondarenko, Andrew C Nichols, Gang Xiao, Rachel Liuqing Shi, Pik Kay Chan, David J Semin

MAbs· November 2021

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Enabling development, manufacturing, and regulatory approval of biotherapeutics through advances in mass spectrometry.
Izydor Apostol, Pavel V Bondarenko, Da Ren, David J Semin, Chao-Hsiang Wu

Curr Opin Biotechnol· October 2021

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Development and Validation of a HPLC-UV Method for Urea and Related Impurities.
Getachew Woldemariam, Ali Kyad, Stephanie Moore, Jinshu Qiu, David Semin

PDA J Pharm Sci Technol· January 2021

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A Risk-Based Approach to Evaluate and Control Elemental Impurities in Therapeutic Proteins.
Yanxin Luo, Chandra Sekhar, Hans Lee, Kiyoshi Fujimori, Michael Ronk, David Semin

J Pharm Sci· November 2020

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Determination of interactions between antibody biotherapeutics and copper by size exclusion chromatography (SEC) coupled with inductively coupled plasma mass spectrometry (ICP/MS).
Yanxin Luo, Michael Ronk, Marisa K Joubert, David Semin, Yasser Nashed-Samuel

Anal Chim Acta· November 2019

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Analysis of 4-bromo-3-fluorobenzaldehyde and separation of its regioisomers by one-dimensional and two-dimensional gas chromatography.
Bo Shen, David Semin, Jan Fang, Gary Guo

J Chromatogr A· September 2016

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Applicability of total reflection X-ray fluorescence (TXRF) as a screening platform for pharmaceutical inorganic impurity analysis.
Bradley J Shaw, David J Semin, Michael E Rider, Meredith R Beebe

J Pharm Biomed Anal· April 2012

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Direct separation and detection of biogenic amines by ion-pair liquid chromatography with chemiluminescent nitrogen detector.
Jingshun Sun, Hong-Xun Guo, David Semin, Janet Cheetham

J Chromatogr A· July 2011

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Chromatographic studies of unusual on-column degradations of aniline compounds on XBridge Shield RP18 column in high pH aqueous mobile phase.
Fang Wang, Xiao-Keng Liu, Susanna Lai, Jan Fang, David Semin

J Chromatogr A· June 2011

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Determination of residual isobutylene oxide--a genotoxic starting material in a drug substance by static headspace gas chromatography.
Jun Han, David Yeung, Fang Wang, David Semin

J Chromatogr Sci· August 2008

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Purification method development for chiral separation in supercritical fluid chromatography with the solubilities in supercritical fluid chromatographic mobile phases.
Kyung H Gahm, Helming Tan, Jodi Liu, Wesley Barnhart, John Eschelbach, David Semin

J Pharm Biomed Anal· April 2008

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Stability-indicating hydrophilic interaction liquid chromatography method for highly polar and basic compounds.
Min Liu, Emily X Chen, Ruthie Ji, David Semin

J Chromatogr A· April 2008

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Effect of column temperature on enantioseparation of dihydropyrimidinones using alcohol solvated Chiralpak AS and AS-H columns.
Fang Wang, Jun Han, David Yeung, David Semin, Janet Cheetham

J Sep Sci· April 2008

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Column temperature programming in enantioseparation of dihydropyrimidinone compounds using derivatized cellulose and amylose chiral stationary phases.
Fang Wang, David Yeung, Jun Han, David Semin, James S McElvain

J Sep Sci· March 2008

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