From cell line development to the formulated drug product: The art of manufacturing therapeutic monoclonal antibodies

SC Carrara, M Ulitzka, J Grzeschik, H Kornmann… - International Journal of …, 2021 - Elsevier
Therapeutic monoclonal antibodies and related products have steadily grown to become the
dominant product class within the biopharmaceutical market. Production of antibodies …

Emerging biomaterials for downstream manufacturing of therapeutic proteins

Y Li, D Stern, LL Lock, J Mills, SH Ou, M Morrow, X Xu… - Acta biomaterialia, 2019 - Elsevier
Downstream processing is considered one of the most challenging phases of industrial
manufacturing of therapeutic proteins, accounting for a large portion of the total production …

Determination of size variants by CE-SDS for approved therapeutic antibodies: Key implications of subclasses and light chain specificities

E Wagner, O Colas, S Chenu, A Goyon… - … of pharmaceutical and …, 2020 - Elsevier
In the present work, a generic non-reducing capillary electrophoresis sodium dodecyl
sulphate (nrCE-SDS) method was tested for a wide range of 26 FDA and EMA approved …

Antibody disulfide bond reduction and recovery during biopharmaceutical process development—A review

T Ren, Z Tan, V Ehamparanathan… - Biotechnology and …, 2021 - Wiley Online Library
Antibody disulfide bond reduction has been a challenging issue in monoclonal antibody
manufacturing. It could lead to a decrease of product purity and failure to meet the targeted …

Impact of depth filtration on disulfide bond reduction during downstream processing of monoclonal antibodies from CHO cell cultures

B O'Mara, ZH Gao, M Kuruganti… - Biotechnology and …, 2019 - Wiley Online Library
Monoclonal antibody interchain disulfide bond reduction was observed in a Chinese
Hamster Ovary manufacturing process that used single‐use technologies. A similar …

Determination of free sulfhydryl contents for proteins including monoclonal antibodies by use of SoloVPE

Y Zhang, P Qi - Journal of Pharmaceutical and Biomedical Analysis, 2021 - Elsevier
Free sulfhydryls are important properties of protein products including monoclonal
antibodies (mAbs). Here, a new technology, variable pathlength extension (SoloVPE), is …

[HTML][HTML] Gastrointestinal tract stabilized protein delivery using disulfide thermostable exoshell system

S Sadeghi, G Vallerinteavide Mavelli… - International Journal of …, 2022 - mdpi.com
Thermostable exoshells (tES) are engineered proteinaceous nanoparticles used for the
rapid encapsulation of therapeutic proteins/enzymes, whereby the nanoplatform protects the …

Integrated transcriptome and in vitro analysis revealed anti-proliferative effect of sodium perborate on hepatocellular carcinoma cells

ZO Ulu, ZB Bolat, F Sahin - Journal of Trace Elements in Medicine and …, 2022 - Elsevier
Background Hepatocelular carcinoma is one of the leading cancer types with no effective
cure as poor prognosis is still a challenging aspect. Thus, alternative therapeutics are …

Optimization and kinetic modeling of interchain disulfide bond reoxidation of monoclonal antibodies in bioprocesses

P Tang, Z Tan, V Ehamparanathan, T Ren, L Hoffman… - Mabs, 2020 - Taylor & Francis
Disulfide bonds play a crucial role in folding and structural stabilization of monoclonal
antibodies (mAbs). Disulfide bond reduction may happen during the mAb manufacturing …

Mechanistic insights into inter-chain disulfide bond reduction of IgG1 and IgG4 antibodies

Y Song, H Cai, Z Tan, N Mussa, ZJ Li - Applied Microbiology and …, 2022 - Springer
Therapeutic monoclonal antibodies (mAbs), primarily immunoglobin G1 (IgG1) and IgG4
with an engineered CPPC motif in its hinge region, are predominant biologics. Inter-chain …