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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 …
dominant product class within the biopharmaceutical market. Production of antibodies …
Emerging biomaterials for downstream manufacturing of therapeutic proteins
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 …
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 …
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 …
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 …
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 …
antibodies (mAbs). Here, a new technology, variable pathlength extension (SoloVPE), is …
[HTML][HTML] Gastrointestinal tract stabilized protein delivery using disulfide thermostable exoshell system
Thermostable exoshells (tES) are engineered proteinaceous nanoparticles used for the
rapid encapsulation of therapeutic proteins/enzymes, whereby the nanoplatform protects 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
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 …
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 …
antibodies (mAbs). Disulfide bond reduction may happen during the mAb manufacturing …
Mechanistic insights into inter-chain disulfide bond reduction of IgG1 and IgG4 antibodies
Therapeutic monoclonal antibodies (mAbs), primarily immunoglobin G1 (IgG1) and IgG4
with an engineered CPPC motif in its hinge region, are predominant biologics. Inter-chain …
with an engineered CPPC motif in its hinge region, are predominant biologics. Inter-chain …