Article
Chemistry, Medicinal
Chamalee L. D. Gamage, David D. Weis, Benjamin T. Walters
Summary: The safety tolerances on particle levels in drug products need to be determined and minimized during development. Agitation stress increases particle formation rates by causing protein instability at the air-water interface, and the addition of polysorbate can eliminate this instability.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2022)
Article
Biochemical Research Methods
Patrycja Zimoch, Tomasz Rumanek, Michal Kolodziej, Wojciech Piatkowski, Dorota Antos
Summary: In this study, a coupled process combining ion exchange chromatography and polyethylene glycol precipitation was developed to remove acidic charge variants of monoclonal antibodies. The model evaluation showed that the coupled process outperformed stand-alone ion exchange chromatography, with the improvement in throughput depending on the initial content and reduction demand of the acidic variants.
JOURNAL OF CHROMATOGRAPHY A
(2023)
Article
Chemistry, Medicinal
Kohei Soeda, Kengo Arai, Tetsuya Yamamoto, Katsuya Ofuji, Masakazu Fukuda, Daisuke Hashimoto, Yuji Yamanaka
Summary: The formation of visible particles (VPs) in liquid monoclonal antibody formulations is a significant quality concern. This study investigates the mechanisms of protein-polydimethylsiloxane (PDMS) VP formation and identifies the dominant spot and pathway in a specific vial formulation. Factors such as drug solution adhesion, storage orientation, silicone coating, vial material, and surfactant hydrophobicity have a notable impact on VP formation. The findings contribute to a better understanding of VP formation mechanisms and provide strategies for mitigating VPs in biotherapeutics.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2023)
Article
Biochemistry & Molecular Biology
Kai Zheng, Diya Ren, Y. John Wang, Wayne Lilyestrom, Thomas Scherer, Justin K. Y. Hong, Junyan A. Ji
Summary: Oxidation is a key degradation pathway for protein drugs, which can impact product efficacy and patient safety. This study found that oxidation led to the oxidation of methionine and tryptophan residues, as well as increased protein aggregation. Excipients such as tryptophan, pyridoxine, or tyrosine were shown to effectively reduce protein aggregation induced by oxidative stress.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2021)
Article
Biochemical Research Methods
Szabolcs Fekete, Amarande Murisier, Matthew Lauber, Davy Guillarme
Summary: This article presents a practical solution to improve the linearity of effluent pH response in pH gradient cation exchange chromatography (CEX) by converting pH to mobile phase volume fraction and generating an inverse response function in the time domain. By setting the inverse function as the gradient program, an ideally linear pH response can be achieved.
JOURNAL OF CHROMATOGRAPHY A
(2021)
Article
Chemistry, Medicinal
Kohei Soeda, Masakazu Fukuda, Masaya Takahashi, Hirotaka Imai, Kengo Arai, Satoshi Saitoh, Ravuri S. K. Kishore, Nuria Sancho Oltra, Jeremy Duboeuf, Daisuke Hashimoto, Yuji Yamanaka
Summary: This study demonstrates the importance of hydrophobicity of Poloxamer 188 (PX188) in controlling visible particle (VP) formation in biotherapeutic formulations. The variability in hydrophobicity among different PX188 lots can affect surfactant function and VP formation. Monitoring lot-to-lot variability of PX188 is crucial for improving and controlling its material attributes in liquid biotherapeutic formulations.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2022)
Article
Biochemical Research Methods
Amarande Murisier, Bastiaan L. Duivelshof, Szabolcs Fekete, Julien Bourquin, Andrew Schmudlach, Matthew A. Lauber, Jennifer M. Nguyen, Alain Beck, Davy Guillarme, Valentina D'Atri
Summary: This study successfully demonstrated the direct hyphenation of cation exchange chromatography with a compact Time of Flight mass spectrometer for analyzing monoclonal antibodies. By testing various buffers and column dimensions, optimal chromatographic conditions were identified for rapid analysis of charge variants.
JOURNAL OF CHROMATOGRAPHY A
(2021)
Article
Chemistry, Medicinal
Arthur J. Schick, Li Yi, Philippe Lam, Preston Pallante, Nathaniel Swanson, Jacqueline Y. Tyler
Summary: Sterile filtration is a critical step in the manufacturing process of biological therapeutics, but protein adsorption to filter surfaces can lead to issues. By adjusting the Debye screening length parameters of the solution, the loss of high molecular weight species during filtration can be influenced.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2021)
Article
Chemistry, Medicinal
Kelvin B. Rembert, Jifeng Zhang, Young Jong Lee
Summary: The impact of five representative Hofmeister salts on the thermal stability and aggregation kinetics of a slightly acidic monoclonal antibody was investigated. The results showed that MgCl2 and NaSCN significantly decreased the unfolding transition temperature of the antibody, while the nucleation rate was influenced by all salts tested, with different trends depending on the surface charge of the antibody. The observed effects can be attributed to ion-specific mechanisms dominated by short-range amide backbone binding and long-range electrostatic binding of ions to charged amino acid side chains.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2023)
Review
Chemistry, Medicinal
Joachim Schuster, Hanns-Christian Mahler, Susanne Joerg, Joerg Huwyler, Roman Mathaes
Summary: Therapeutic proteins are administered through injection or infusion, and the physiological environment in the body compartment can impact protein stability post-administration. This can lead to changes in safety and efficacy, with protein aggregation and fragmentation being critical quality attributes of the drug product. Analytical approaches are needed to assess stability under simulated physiological conditions and to understand factors causing in vivo protein aggregation, precipitation, and fragmentation in biological fluids. Improved analytical methods are necessary for tracking protein stability and for supporting the development of therapeutic proteins.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2021)
Article
Biochemical Research Methods
Vijesh Kumar, Samuel Leweke, William Heymann, Eric von Lieres, Fabrice Schlegel, Karin Westerberg, Abraham M. Lenhoff
Summary: Mechanistic models for ion-exchange chromatography of proteins are well-established, but discrepancies in peak position and shape still exist, especially in the non-linear range of column load level. The objective of this study is to predict traditional and anomalous phenomena more accurately using model parameters.
JOURNAL OF CHROMATOGRAPHY A
(2021)
Article
Chemistry, Medicinal
Mona Abdel-Tawab, Srijib Banerjee, Roland Kirchner, Thomas Wellenhofer, Lukas Hahn, Lorenz Meinel, Ulrike Holzgrabe, Manfred Schubert-Zsilavecz, Andreas Seidl, Franz Stadler
Summary: The impact of mechanical stress on the formation of subvisible/nanoparticles in monoclonal antibody infusions (mAb-i) was investigated. Pembrolizumab and bevacizumab showed the highest propensity for particle formation, especially at low concentrations. The unknown health risks associated with the long-term application of subvisible particles (SVPs)/nanoparticles in mAb-i highlight the importance of stability studies and minimizing storage time and mechanical stress during transport, especially for low-concentrated mAb-i. Additionally, washing siliconized syringes with saline solution can minimize particle entry.
ARCHIV DER PHARMAZIE
(2023)
Article
Polymer Science
David March, Valentino Bianco, Giancarlo Franzese
Summary: This study investigated the influence of a hydrophobic surface on the behavior of proteins near interfaces, showing that the hydrophobic surface as well as other parameters affect protein unfolding and aggregation. These results have potential implications for neurodegenerative diseases.
Article
Chemistry, Medicinal
Andreas Stelzl, Stefan Schneid, Gerhard Winter
Summary: The study explored the use of tunable resistive pulse sensing for quantifying submicron particles in biopharmaceutical solutions, emphasizing the necessity of an electrolyte concentration of at least 50 mM sodium chloride for correct particle quantification. Results showed a significant underestimation of particle counts below 250 nm.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2021)
Article
Chemistry, Medicinal
Caitlin Wood, Vladimir Razinkov, Wei Qi, Eric M. Furst, Christopher J. Roberts
Summary: This study introduces a rapid method to evaluate protein aggregation propensity at air-water interfaces (AWI). Temperature had minimal effect under this technique's rapid interface turnover time scales, while electrostatic protein-protein interactions mediated by pH changes were more influential for particle formation via AWI. Nonionic surfactants substantially reduced particle formation for monoclonal antibodies, but not for a globular protein.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2021)
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)