Molecular and functional analysis of monoclonal antibodies in support of biologics development

X Wang, Z An, W Luo, N Xia, Q Zhao - Protein & cell, 2018 - academic.oup.com
Monoclonal antibody (mAb)-based therapeutics are playing an increasingly important role in
the treatment or prevention of many important diseases such as cancers, autoimmune …

Process intensification in biologics manufacturing

J Strube, R Ditz, M Kornecki, M Huter, A Schmidt… - … and Processing-Process …, 2018 - Elsevier
Over the last decade, the term process intensification (PI) has been applied almost
exclusively to large scale chemical processes, but hardly to aspects of biopharmaceutical …

Ultrasensitive characterization of charge heterogeneity of therapeutic monoclonal antibodies using strong cation exchange chromatography coupled to native mass …

Y Yan, AP Liu, S Wang, TJ Daly, N Li - Analytical chemistry, 2018 - ACS Publications
In therapeutic monoclonal antibody (mAb) development, charge heterogeneity of a mAb
molecule is often associated with critical quality attributes and is therefore monitored …

Stability assessment of antibody-drug conjugate Trastuzumab emtansine in comparison to parent monoclonal antibody using orthogonal testing protocol

HE Mohamed, AA Mohamed, MA Al-Ghobashy… - … of pharmaceutical and …, 2018 - Elsevier
Antibody-drug conjugates (ADC) represent an emerging, novel class of biopharmaceuticals.
The heterogeneity originating from the sophisticated structure requires orthogonal analytical …

Characterizing various monoclonal antibodies with milder reversed phase chromatography conditions

B Bobály, V D'Atri, M Lauber, A Beck… - … of Chromatography B, 2018 - Elsevier
Reversed phase liquid chromatography (RPLC) of therapeutic monoclonal antibodies
(mAbs) is often performed at elevated temperatures (80–90° C) and in the presence of …

Purification of antibody fragments for the reduction of charge variants using cation exchange chromatography

HJ Lee, CM Lee, K Kim, JM Yoo, S Kang, G Ha… - … of Chromatography B, 2018 - Elsevier
Recently, antibody fragments have been studied as therapeutic agents because they lack Fc
effector function while having affinity similar to their original monoclonal antibody and can be …

Simple and ultra-fast recognition and quantitation of compounded monoclonal antibodies: Application to flow injection analysis combined to UV spectroscopy and …

E Jaccoulet, A Schweitzer-Chaput, B Toussaint… - Talanta, 2018 - Elsevier
Compounding of monoclonal antibody (mAbs) constantly increases in hospital. Quality
control (QC) of the compounded mAbs based on quantification and identification is required …

Development and validation of salt gradient CEX chromatography method for charge variants separation and quantitative analysis of the IgG mAb-cetuximab

A Farjami, M Siahi-Shadbad, P Akbarzadehlaleh… - Chromatographia, 2018 - Springer
Ion exchange chromatography is widely used for charge variant analysis of proteins,
including monoclonal antibodies. In this study, a simple and robust salt gradient cation …

Quantitation of the monoclonal antibody Denosumab by bioassay and validated LC methods

RF Perobelli, B Xavier, AR da Silveira… - International journal of …, 2018 - Elsevier
Abstract The monoclonal antibody Denosumab (DmAb) is clinically used to treat
osteoporosis and bone loss. We developed a bioassay based on the ability of DmAb to …

Influence of ultrasonication prior to glycation on the physicochemical properties of bovine serum albumin–galactose conjugates

J Liu, Z Tu, L Zhang, H Wang, X Sha… - Food Science and …, 2018 - jstage.jst.go.jp
The effects of different ultrasonic powers, times and temperatures on the physicochemical
properties of bovine serum albumin (BSA)–galactose conjugates were investigated. SDS …