Article
Chemistry, Analytical
Lin Luo, Bowen Jiang, Yuan Cao, Long Xu, Mohammed Shameem, Dingjiang Liu
Summary: A hydrophobic interaction chromatography method was developed in this study for the separation and accurate quantitation of three mAbs in a co-formulated drug product, demonstrating high accuracy and linear relationship. This method can effectively monitor concentration changes during stability studies.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
(2021)
Article
Engineering, Chemical
Kenichi Nagase, Sakiko Kitazawa, Toshihiko Kogure, Sota Yamada, Kazuhiro Katayama, Hideko Kanazawa
Summary: A temperature-modulated viral vector purification column using a mixed polymer brush as packing material was developed in this study. The column successfully eluted the AAV2 vector and separated it from bovine serum proteins.
SEPARATION AND PURIFICATION TECHNOLOGY
(2022)
Article
Chemistry, Analytical
Kenichi Nagase, Yuta Ishizawa, Masakazu Inoue, Matsurika Kokubun, Sota Yamada, Hideko Kanazawa
Summary: The temperature-responsive spin column presents a simple sample preparation method using all-aqueous eluent for protein removal from serum, required for serum drug analysis. Two types of silica beads grafted with temperature-responsive copolymers were utilized as packing materials, enabling effective separation of serum proteins and analytes by changing the temperature during elution.
ANALYTICA CHIMICA ACTA
(2021)
Article
Biotechnology & Applied Microbiology
Sumit K. Singh, Kelvin H. Lee
Summary: Glycosylation is a critical quality attribute of monoclonal antibody therapeutics. Hydrophilic interaction liquid chromatography-mass spectrometry (HILIC-MS) is a valuable technology for glycosylation characterization. Traditional glycan analysis based on glucose units (GU) and accurate mass (AM) is not suitable for complex samples or high-throughput applications. This study presents a two-step strategy for targeted glycan analysis and its application in different scenarios.
FRONTIERS IN BIOENGINEERING AND BIOTECHNOLOGY
(2022)
Article
Chemistry, Physical
Jia Hui Chen, Wei Ting Gao, Yvonne Shuen Lann Choo, Xue Lang Gao, Ying Jie Liu, Xi Bin Yue, Xi Hao Wang, Ai Mei Zhu, Qiu Gen Zhang, Qing Lin Liu
Summary: A series of anion exchange membranes (AEMs) with semi-interpenetrating polymer network (sIPN) incorporating crosslinked poly(biphenyl N-methylpiperidine) (PBP) and spirobisindane-based intrinsically microporous poly(ether ketone) (PEK-SBI) have been prepared to achieve high ionic conductivity and improved chemical stability. The AEMs exhibit phase separated structures, promoting the hydroxide ion conductivity. Among them, the sIPN-90/10(PEK-SBI) AEM shows the highest hydroxide ion conductivity of 122.4 mS cm-1 and good alkaline stability. Moreover, it can achieve a peak power density of 481 mW cm-2 in a hydrogen/oxygen single cell.
JOURNAL OF COLLOID AND INTERFACE SCIENCE
(2023)
Article
Biochemistry & Molecular Biology
Ke Li, Ondrea Bermudez, Daniel Forciniti
Summary: This study investigated the solubility of fully glycosylated and non-glycosylated human monoclonal antibodies (mAb) expressed in corn by inducing precipitation with poly(ethylene) glycol (PEG). The findings show that glycosylation increases antibody solubility and that existing models cannot accurately capture the effect of glycosylation on protein precipitation by PEG.
PROCESS BIOCHEMISTRY
(2022)
Article
Chemistry, Analytical
Yufeng Sun, Dong Zhu, Ran Tao, Long Li, Bei Fan, Fengzhong Wang
Summary: A gold immunochromatographic sensor was developed for monitoring cannabidiol (CBD), achieving high sensitivity and accuracy in the determination of CBD in products. The sensor demonstrated no cross-reactivity with other substances, showing its reliability and stability.
Article
Chemistry, Analytical
Alexander B. Schwahn, Julia Baek, Shanhua Lin, Christopher A. Pohl, Ken Cook
Summary: Characterization and quality control of biotherapeutic proteins often require multiple orthogonal separation techniques, leading to tedious method development. This study demonstrates the use of a linear controlled pH gradient system and universal buffer solutions to improve efficiency and minimize manual intervention in method development and analysis.
ANALYTICAL CHEMISTRY
(2022)
Article
Nanoscience & Nanotechnology
Abu Zafar Al Munsur, Bon-Hyuk Goo, Youngkwang Kim, Oh Joong Kwon, Sae Yane Paek, So Young Lee, Hyoung-Juhn Kim, Tae-Hyun Kim
Summary: The semi-IPN membrane NPP-95, composed of Nafion, PAA, and PVA, exhibited excellent thermal, mechanical, and dimensional stability, as well as lower permeability and higher conductivity compared to re-Nafion. The membrane showed significantly improved water management and lower hydrogen crossover under actual fuel cell operating conditions. In both PEMFC and PEMWE applications, NPP-95 demonstrated higher current density and better performance than re-Nafion.
ACS APPLIED MATERIALS & INTERFACES
(2021)
Article
Chemistry, Applied
Shengyang Zhou, Lingling Guo, Xinxin Xu, Shanshan Song, Liqiang Liu, Hua Kuang, Yingyue Zhu, Liguang Xu, Chuanlai Xu
Summary: This study constructed a gold nanoparticle-based immunosensor for rapid detection of amanitin in mushroom samples. The results showed that this method had high sensitivity and accuracy, allowing for detection within 10 minutes. It can be widely used in food safety monitoring and clinical diagnosis.
Article
Chemistry, Physical
Lu Zeng, Xinxin Xu, Shanshan Song, Liguang Xu, Liqiang Liu, Jing Xiao, Chuanlai Xu, Hua Kuang
Summary: Novel haptens were designed and synthesized to generate monoclonal antibodies against vitamin B-6, and a group-specific mAb was prepared with gold nanoparticle-based immunochromatographic strip for the detection of VB6 in fortified foods and dietary supplements. The developed sensor showed promising results for the rapid and specific recognition of VB6.
Article
Chemistry, Medicinal
Ryan Knihtila, Yuanli Song, Letha Chemmalil, Julia Ding, Nesredin Mussa, Zheng Jian Li
Summary: Size Exclusion Chromatography (SEC) is widely used in assessing aggregate content in bio-pharmaceutical drugs like monoclonal antibodies (mAbs), with electrostatic interactions between protein analytes and SEC column resin needing to be minimized. Increasing mobile phase salt concentration can decrease electrostatic interactions but may increase protein hydrophobicity and interactions with the stationary phase. The optimized SEC method conditions were found to be robust and suitable for product release and stability studies, with arginine identified as an essential additive to minimize undesirable hydrophobic interactions.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2021)
Article
Biochemical Research Methods
Wolfgang Koehnlein, Annika Holzgreve, Klaus Schwendner, Romas Skudas, Florian Schelter
Summary: Immunoglobulins of complex formats have the potential to improve biopharmaceutical efficacy. However, their purification faces challenges due to the removal of impurities and the hydrophobicity of the antibodies. This study developed a mixed mode resin with 2-amino-4methylpentanoic acid ligands to address these challenges and successfully separated impurities from hydrophobic bispecific antibodies. The resin showed high selectivity, broad applicability, and simplified downstream processing.
JOURNAL OF CHROMATOGRAPHY A
(2023)
Article
Medicine, Research & Experimental
Shravan Sreenivasan, Anurag S. Rathore
Summary: This study investigated the aggregation of mAb in the presence of Fe2+ and H2O2 in saline and in vitro models. The results showed that the combined presence of Fe2+ and H2O2 increased mAb aggregation and altered protein structure and hydrophobicity. Increasing the time, temperature, and Fe2+ and H2O2 concentration further enhanced mAb aggregation. Additionally, mAb samples with copper and cobalt chlorides also resulted in degradation.
MOLECULAR PHARMACEUTICS
(2023)
Article
Electrochemistry
Edson Silvio Batista Rodrigues, Giovanna Nascimento de Mello e Silva, Isaac Yves Lopes de Macedo, Wallans Torres Pio dos Santos, Guilherme Rocha Lino de Souza, Gabriel Henrique Santos, Isabela Jube Wastowski, Hatice Ceren Ates, Can Dincer, Eric de Souza Gil
Summary: An impedimetric immunosensor was developed for the detection of RTX from invasive and non-invasive samples. The immunosensor showed high precision and accuracy for on-site RTX detection in blood serum and urine samples. This affordable and label-free electrochemical immunosensor could be used for therapeutic drug monitoring, quality control, and stability monitoring of different drugs.
JOURNAL OF THE ELECTROCHEMICAL SOCIETY
(2022)