Article
Medicine, Research & Experimental
Suman Saurabh, Cavan Kalonia, Zongyi Li, Peter Hollowell, Thomas Waigh, Peixun Li, John Webster, John M. Seddon, Jian R. Lu, Fernando Bresme
Summary: Histidine buffer can stabilize monoclonal antibody formulations by shielding hydrophobic regions on the protein surface.
MOLECULAR PHARMACEUTICS
(2022)
Article
Pharmacology & Pharmacy
Busra Gurel, Melike Berksoz, Eda Capkin, Ayhan Parlar, Meltem Corbacioglu Pala, Aylin Ozkan, Yilmaz Capan, Duygu Emine Daglikoca, Meral Yuce
Summary: Avastin (R) is a recombinant monoclonal antibody used in cancer treatment. The biosimilar candidate SIMAB054 developed in this study showed different charge variant profile compared to the innovator product. The structural and functional analysis revealed that they share common glycoforms and post-translational modifications, but with different ratios in some samples. The differences mainly originated from the presence of extra C-terminal lysine residues.
Article
Biochemical Research Methods
Liesa Verscheure, An Cerdobbel, Pat Sandra, Frederic Lynen, Koen Sandra
Summary: This study reported a fully automated method for characterizing monoclonal antibody charge variants, which significantly reduces operation time and sample loss, and improves information gathering efficiency. The method can effectively reveal major and minor charge variants, as well as post-translational modifications and modification sites.
JOURNAL OF CHROMATOGRAPHY A
(2021)
Article
Biochemical Research Methods
Sunil Kumar, Vineela Peruri, Anurag S. Rathore
Summary: In this study, an online volatile-salt-containing two-dimensional liquid chromatography (2D-LC) method coupled with mass spectrometry (MS) was used to characterize the charge heterogeneity of monoclonal antibodies (mAbs). The 2D-LC method successfully separated and identified more mAb variants, including minor variations in charge distribution or conformation that could not be detected by single analytical methods alone.
JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY
(2023)
Article
Biochemical Research Methods
Gaoya Yuan, Xudong Zhang, Yuanyi Zhang, Wanyuan Dong, Yifeng Li
Summary: In this work, a method for continuous separation and collection of acidic and basic charge variants was developed, enabling efficient generation of these variants with high purity.
PROTEIN EXPRESSION AND PURIFICATION
(2023)
Article
Oncology
Sara S. Rinne, Charles Dahlsson Leitao, Ayman Abouzayed, Anzhelika Vorobyeva, Vladimir Tolmachev, Stefan Stahl, John Lofblom, Anna Orlova
Summary: The study suggests that affibody-based tracers are more suitable for PET imaging of HER3 expression, providing better imaging contrast and faster clearance from blood and normal organs.
Article
Biochemical Research Methods
Yifeng Li
Summary: For monoclonal antibodies produced in mammalian cells, ensuring viral safety is crucial. The combination of column chromatography, virus inactivation, and nanofiltration can effectively clear potential endogenous and adventitious viruses.
PROTEIN EXPRESSION AND PURIFICATION
(2022)
Article
Chemistry, Applied
Zlatina Chengolova, Yavor Ivanov
Summary: A rapid and sensitive immunoassay using magnetic nanoparticles was developed for the determination of Ochratoxin A (OTA) in various foods. The assay showed a low detection limit, wide linear range, high recovery rates, and good repeatability.
BIOINTERFACE RESEARCH IN APPLIED CHEMISTRY
(2023)
Article
Biotechnology & Applied Microbiology
Nicole Swope, Wai Keen Chung, Mingyan Cao, Dana Motabar, Dengfeng Liu, Sanjeev Ahuja, Michael Handlogten
BIOTECHNOLOGY AND BIOENGINEERING
(2020)
Article
Medicine, Research & Experimental
Jun Kim, Yoen Joo Kim, Mingyan Cao, Niluka De Mel, Kenneth Miller, Jared S. Bee, Jihong Wang, Xiangyang Wang, Methal Albarghouthi
Article
Chemistry, Medicinal
Xiaojun Lu, Shihua Lin, Niluka De Mel, Arun Parupudi, Jared Delmar, Madhu Pandey, Xiangyang Wang, Jihong Wang
JOURNAL OF PHARMACEUTICAL SCIENCES
(2020)
Article
Multidisciplinary Sciences
Ben Niu, Michael Martinelli II, Yang Jiao, Chunlei Wang, Mingyan Cao, Jihong Wang, Eric Meinke
Article
Biochemical Research Methods
Trina Mouchahoir, John E. Schiel, Rich Rogers, Alan Heckert, Benjamin J. Place, Aaron Ammerman, Xiaoxiao Li, Tom Robinson, Brian Schmidt, Chris M. Chumsae, Xinbi Li, Anton Manuilov, Bo Yan, Gregory O. Staples, Da Ren, Alexander J. Veach, Dongdong Wang, Wael Yared, Zoran Sosic, Yan Wang, Li Zang, Anthony M. Leone, Peiran Liu, Richard Ludwig, Li Tao, Wei Wu, Ahmet Cansizoglu, Andrew Hanneman, Greg W. Adams, Irina Perdivara, Hunter Walker, Margo Wilson, Arnd Brandenburg, Nick DeGraan-Weber, Stefano Gotta, Joe Shambaugh, Melissa Alvarez, X. Christopher Yu, Li Cao, Chun Shao, Andrew Mahan, Hirsh Nanda, Kristen Nields, Nancy Nightlinger, Helena Maria Barysz, Michael Jahn, Ben Niu, Jihong Wang, Gabriella Leo, Nunzio Sepe, Yan-Hui Liu, Bhumit A. Patel, Douglas Richardson, Yi Wang, Daniela Tizabi, Oleg Borisov, Yali Lu, Ernest L. Maynard, Albrecht Gruhler, Kim F. Haselmann, Thomas N. Krogh, Carsten P. Sonksen, Simon Letarte, Sean Shen, Kristin Boggio, Keith Johnson, Wenqin Ni, Himakshi Patel, David Ripley, Jason C. Rouse, Ying Zhang, Carly Daniels, Andrew Dawdy, Olga Friese, Thomas W. Powers, Justin B. Sperry, Josh Woods, Eric Carlson, K. Ilker Sen, St John Skilton, Michelle Busch, Anders Lund, Martha Stapels, Xu Guo, Sibylle Heidelberger, Harini Kaluarachchi, Sean McCarthy, John Kim, Jing Zhen, Ying Zhou, Sarah Rogstad, Xiaoshi Wang, Jing Fang, Weibin Chen, Ying Qing Yu, John G. Hoogerheide, Rebecca Scott, Hua Yuan
Summary: The MAM Consortium conducted an interlaboratory study to evaluate NPD performance across the industry, with results showing representative high-resolution MS capabilities. Critical elements of NPD were identified to further refine the methodology and speed up adoption into manufacturer-specific protein therapeutic product life cycles.
JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY
(2021)
Article
Chemistry, Analytical
Chen Qian, Ben Niu, Rod Brian Jimenez, Jihong Wang, Methal Albarghouthi
Summary: The multi-attribute method based on liquid chromatography-tandem mass spectrometry is a powerful tool for monitoring multiple product quality attributes simultaneously, and a need for a universal and high-throughput workflow has been identified to better implement this method. Manual sample preparation for MAM is labor intensive and produces variations, therefore a fully automated peptide mapping procedure has been developed to improve sample handling capacity and outcome reproducibility.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
(2021)
Article
Chemistry, Medicinal
Mingyan Cao, Conner Parthemore, Yang Jiao, Samuel Korman, Matthew Aspelund, Alan Hunter, Greg Kilby, Xiaoyu Chen
Summary: A novel chain-pairing mispair in a bispecific antibody (bsAb) was reported, and an analytical strategy was implemented to monitor and characterize this mispair to reduce risks for future products. Process improvements have successfully reduced the mispair to as low as 0.2% in the final product.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2021)
Article
Chemistry, Medicinal
Mingyan Cao, Niluka De Mel, Jihong Wang, Conner Parthemore, Yang Jiao, Weimin Chen, Shihua Lin, Dengfeng Liu, Greg Kilby, Xiaoyu Chen
Summary: In this study, N-terminal E cyclization was identified as the major degradation pathway for monoclonal antibodies and bispecific antibodies in lyophilized formulations. The use of salt-gradient ion exchange chromatography and hydrophobic interaction chromatography effectively separated pE, and pE did not affect the binding activity of the antibodies. In vitro experiments suggested a potential role of serum matrix in pE conversion.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2022)
Article
Medicine, Research & Experimental
Jared A. Delmar, Eugen Buehler, Ashwin K. Chetty, Agastya Das, Guillermo Miro Quesada, Jihong Wang, Xiaoyu Chen
Summary: The study focuses on the photooxidation of Met and Trp residues in therapeutic proteins, creating computational models using machine learning algorithms, and identifying important parameters influencing photooxidation.
MOLECULAR THERAPY-METHODS & CLINICAL DEVELOPMENT
(2021)
Article
Chemistry, Medicinal
Jared A. Delmar, Claire Harris, Luigi Grassi, Nathaniel Macapagal, Jihong Wang, Diane Hatton, Weichen Xu
Summary: Mis-splicing events in the heavy chain transcript were found to generate LMW species, which were successfully removed by an optimized purification process. Transcriptomic analysis tools play a key role in identifying unknown species.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2022)
Article
Biochemical Research Methods
Kamiyar Rezvani, Andrew Smith, Jannat Javed, William R. Keller, Kevin D. Stewart, Logan Kim, Kelcy J. Newell
Summary: The biopharmaceutical industry relies on high-throughput systems and strategies for biologics manufacturing process development. While these systems provide valuable data, their interpretation often requires complex data transformation and time-intensive system characterization. The use of Tecan automated liquid handling systems with RoboColumns for purification development has shown promising results, but the lack of an optimized liquid delivery system limits their performance. This study introduces a Tecan Freedom EVO high-throughput purification tool that enables continuous gradient elution capability, leading to improved performance and consistency between RoboColumns and larger column formats.
JOURNAL OF CHROMATOGRAPHY A
(2023)
Article
Medicine, Research & Experimental
Mingyan Cao, Yang Jiao, Conner Parthemore, Samuel Korman, Jiao Ma, Alan Hunter, Greg Kilby, Xiaoyu Chen
Summary: The study identifies C(H)2 domain cleavages due to proteolytic activity at L306 and L309, leading to a shoulder peak in nrCE-SDS, which could aid manufacturers in process improvement and stability studies of therapeutic antibodies.
Article
Medicine, Research & Experimental
Weimin Chen, Madhu Pandey, Hong Sun, Andrea Rolong, Mingyan Cao, Dengfeng Liu, Jihong Wang, Lingmin Zeng, Alan Hunter, Shihua Lin
Summary: T-cell-mediated immunotherapy has gained attention for targeting immune checkpoint molecules. Bispecific antibodies targeting two antigen targets have shown promise for cancer immunotherapy. Developing appropriate bioassays to measure potency and characterize biological properties of BsAbs is crucial. A dual target reporter bioassay presented here can accurately measure potency of BsAbs targeting CTLA-4 and PD-1, reflecting the potential MOA and synergistic effects of these bispecific biologics.
Correction
Biochemical Research Methods
Yong Wang, Suhua Yu, Rui Li, Jing Wan, Yuheng Wang, Zongli Huo, Chunyong Wu, Li Mi, Songqin Liu
JOURNAL OF CHROMATOGRAPHY A
(2024)
Review
Biochemical Research Methods
Israel D. Souza, Maria Eugenia C. Queiroz
Summary: Organic-silica hybrid monolithic materials have gained significant attention in separation science and sample preparation due to their unique properties. This review summarizes the characteristics, current status, and recent developments of these materials, as well as discusses synthesis methods, characterization techniques, and strategies for improving extraction efficiency in various applications.
JOURNAL OF CHROMATOGRAPHY A
(2024)
Article
Biochemical Research Methods
Bhagwat Upreti, Bhanu Prasad Vempatapu, Jagdish Kumar, Pankaj K. Kanaujia
Summary: Lubricating oils are essential for the effective performance of internal combustion engines. This study presents a new HPLC method for determining additives in finished lubricating oils and polar substances in used engine oils.
JOURNAL OF CHROMATOGRAPHY A
(2024)
Article
Biochemical Research Methods
Zongqing Huang, Haoju Hua, Xiuzhen Du, Zipeng Zhen, Wei Zhao, Jun Feng, Ji-an Li
Summary: This study successfully isolated VHHs against the SUMO protein for the first time using biopanning of an immune camelid nanobody library. The VHHs were coupled to agarose resins to form affinity chromatography resins, allowing for one-step purification of various SUMO fusions.
JOURNAL OF CHROMATOGRAPHY A
(2024)
Article
Biochemical Research Methods
Xueting Qiu, Xuben Hou, Yue Yang, Hao Fang, Fei Cui, Xinying Yang
Summary: In this study, a new method based on electrophoretically mediated microanalysis was developed for the investigation of PTPRO enzymatic activity. The method was successfully used to determine the kinetics of PTPRO and the inhibitory concentration of PTPRO inhibitors. The method exhibited improved accuracy and reduced consumption compared to traditional methods.
JOURNAL OF CHROMATOGRAPHY A
(2024)
Article
Biochemical Research Methods
Feifei Luo, Mengmeng Hao, Lei Zhang, Yangguo Xie, Wei Hou, Hongya Wang, Zhongli Zhang
Summary: In this study, a comprehensive screening and structure elucidation of 23 nonvolatile organic compounds (NVOCs) in two antibody drugs was conducted. Seven previously unreported compounds were identified. A quantitative method with high sensitivity, accuracy, and precision was developed for evaluating the safety of NVOCs in drug products.
JOURNAL OF CHROMATOGRAPHY A
(2024)
Article
Biochemical Research Methods
Zuzana Vosahlova, Kveta Kalfkova, Martin Gilar, Jakub Szymarek, Maria Mazurkiewicz-Beldzinska, Sylwia Studzi
Summary: A hydrophilic interaction liquid chromatography method was developed for the separation and identification of oligonucleotide impurities and metabolites, and successfully applied to the analysis of serum samples from Spinraza-treated patients.
JOURNAL OF CHROMATOGRAPHY A
(2024)
Article
Biochemical Research Methods
Aswanidevi Kongasseri, Thirumalai Madhesan, Sangeetha Krishna Kumar, Sushmitha Pedugu Sivaraman, Suchashrita Mitra, Pitchaiah Kancharlapalli Chinaraga, C. V. S. Brahmmananda Rao, Sivaraman Nagarajan, Prabhakaran Deivasigamani, Akhila Maheswari Mohan
Summary: This study focuses on the sequential separation of trivalent lanthanides using modified C-18 silica-packed supports and reversed-phase HPLC technique. By tuning the column modifiers and separation parameters, the researchers achieved systematic separation of Ln(3+). The results showed that the choice of column modifiers and fine-tuning of the modification procedure were crucial for achieving excellent separation.
JOURNAL OF CHROMATOGRAPHY A
(2024)
Article
Biochemical Research Methods
Raquel Perez-Robles, Szabolcs Fekete, Robert Kormany, Natalia Navas, Davy Guillarme
Summary: There is a mismatch between the sample diluent and the mobile phase in HILIC analysis, leading to analyte breakthrough and peak distortion. Adding a weak solvent for pre-injection can effectively prevent these issues and improve sensitivity.
JOURNAL OF CHROMATOGRAPHY A
(2024)
Article
Biochemical Research Methods
Oleg Pokrovskiy, Irina Rostovschikova, Konstantin Ustinovich, Ilya Voronov, Dmitry Kosyakov
Summary: A chromatography-like propagation of water through the material bed was observed during supercritical fluid extraction of aroma plants with high moisture content, which could be significant for modeling the kinetics of supercritical fluid extraction of non-volatile compounds.
JOURNAL OF CHROMATOGRAPHY A
(2024)
Article
Biochemical Research Methods
Yasar Kemal Recepoglu, Ozguer Arar, Asli Yuksel
Summary: Biosorption using phosphorylated hazelnut shell waste (FHS) is a promising method for lithium removal and recovery. This study investigated the performance of a continuous-flow packed-bed column system using FHS for ultra-low level lithium removal. The results showed that the lihium biosorption capacity of the FHS column was unaffected by the bed height, but decreased with increasing flow rate.
JOURNAL OF CHROMATOGRAPHY A
(2024)
Article
Biochemical Research Methods
Jian Sun, Zheheng Zheng, Zixiao Jia, Jiabin Wang, Xucong Lin
Summary: In this study, an ionic covalent organic framework (iCOF) surface grafting monolithic sorbent was prepared for in-tube solid-phase microextraction (SPME) of aristolochic acids (AAs) in various samples. The density of quaternary ammonium ions in the iCOF was modulated for enhanced adsorption of AAs. The iCOF surface grafting monolithic sorbent was confirmed by different means. Several operating conditions were optimized to develop the online in-tube SPME-HPLC method, which showed good linearity, low limits of detection, and high recoveries for AAs in serum samples. This study presents a feasible approach for the application of COF-based monolithic sorbents in sample preparation.
JOURNAL OF CHROMATOGRAPHY A
(2024)
Article
Biochemical Research Methods
Zeng Wen, Ruihan Peng, Die Gao, Jing Lin, Jia Zeng, Zhou Li, Famin Ke, Zhining Xia, Dandan Wang
Summary: A chitosan-alginate sponge with multiple cross-linking networks was developed for adsorption and enrichment of anionic dyes from food samples. The sponge showed better three-dimensional network structure, mechanical behavior, and stability compared to pure chitosan and alginate sponges. The adsorption performance and selectivity of the sponge were systematically studied, and it maintained high adsorption capacity and selectivity for anionic dyes. The sponge also showed satisfactory reusability and was successfully combined with high-performance liquid chromatography for the enrichment and detection of anionic dyes in candy and cocktail samples.
JOURNAL OF CHROMATOGRAPHY A
(2024)
Article
Biochemical Research Methods
Hairong Zhang, Xiaojuan Jiang, Dandan Zhang, Yuexin Yang, Qiang Xie, Caisheng Wu
Summary: Analysis of in vivo exposure to traditional Chinese medicine using mass spectrometry is helpful for identifying effective ingredients and developing new drugs. This study focused on Forsythia suspensa (Lian Qiao) and used metabolomics technology to explore its in vivo exposure. By comparing the differences before and after administration, a complete set of nontargeted analysis strategies for TCM exposure was established. The study identified 393 Lian Qiao-related chemical components in mice after administration, including prototypes and metabolites. This study provides a reference for research on the active ingredients of Lian Qiao in vivo.
JOURNAL OF CHROMATOGRAPHY A
(2024)
Article
Biochemical Research Methods
Oscar Castejon-Musulen, Ricardo Lopez, Ignacio Ontan, Vicente Ferreira
Summary: A quantitative analytical method was developed and validated in this study to determine the concentrations of 81 aroma-relevant wine volatiles. The method utilizes stir bar sorptive extraction and multidimensional gas chromatography with flame ionization detector or mass spectrometer. The method demonstrated good linearity, reproducibility, and recovery, and was successfully applied to analyze 20 wine samples.
JOURNAL OF CHROMATOGRAPHY A
(2024)