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Mechanistic understanding of metal-catalyzed oxidation of polysorbate 80 and monoclonal antibody in biotherapeutic formulations

International Journal of Pharmaceutics, 2022
Surfactants are commonly used in biotherapeutic formulations to prevent the formation of aggregates and protect proteins from denaturation. Among them polysorbates are the most widely used. However, they are known to be prone to degradation, mainly via enzymatic hydrolysis and oxidation.
Fethi Bensaid, Pierre Guibal
exaly   +3 more sources

HP-β-CD for the formulation of IgG and Ig-based biotherapeutics

International Journal of Pharmaceutics, 2021
The main challenge to develop HCF for IgG and Ig-based therapeutics is to achieve essential solubility, viscosity and stability of these molecules in order to maintain product quality and meet regulatory requirement during manufacturing, production, storage, shipment and administration processes.
Helen Haixia, Wu   +2 more
openaire   +2 more sources

Polysorbate degradation in biotherapeutic formulations: Identification and discussion of current root causes

International Journal of Pharmaceutics, 2018
Biotherapeutic protein formulations are often high concentration liquid protein solutions, which are required to be stable under pharmaceutically relevant storage conditions and presence of external stress. Non-ionic detergents like polysorbate have been the most commonly used detergent to maintain formulation stability. Recently, particle formation in
Mridula Dwivedi   +2 more
exaly   +3 more sources

Residue-Specific Impact of EDTA and Methionine on Protein Oxidation in Biotherapeutics Formulations Using an Integrated Biotherapeutics Drug Product Development Workflow

Journal of Pharmaceutical Sciences, 2023
The rational design and selection of formulation composition to meet molecule-specific and product-specific needs are critical for biotherapeutics development to ensure physical and chemical stability. This work, based on three antibody-based (mAb) proteins (mAbA, mAbB, and mAbC), evaluates residue-specific impact of EDTA and methionine on protein ...
Santosh V. Thakkar   +11 more
openaire   +2 more sources

Advanced Formulations/Drug Delivery Systems for Subcutaneous Delivery of Protein-Based Biotherapeutics

Journal of Pharmaceutical Sciences, 2022
Multiple advanced formulations and drug delivery systems (DDSs) have been developed to deliver protein-based biotherapeutics via the subcutaneous (SC) route. These formulations/DDSs include high-concentration solution, co-formulation of two or more proteins, large volume injection, protein cluster/complex, suspension, nanoparticle, microparticle, and ...
Hao Lou, Mei Feng, Michael J. Hageman
openaire   +2 more sources

An in-depth examination of fatty acid solubility limits in biotherapeutic protein formulations containing polysorbate 20 and polysorbate 80

International Journal of Pharmaceutics, 2020
Two of the most widely used surfactants to stabilize biologicals against e.g. interfacial stress are polysorbate20 (PS20) and polysorbate 80 (PS80). In recent years, polysorbate degradation in biopharmaceutical formulations has been observed. Polysorbate (PS) is mainly composed of sorbitan and isosorbide fatty acid (FA) esters, varying in their FA ...
Mridula Dwivedi   +2 more
exaly   +3 more sources

Chitosan-based formulations of drugs, imaging agents and biotherapeutics

Advanced Drug Delivery Reviews, 2010
This preface is part of the Advanced Drug Delivery Reviews theme issue on “Chitosan-Based Formulations of Drugs, Imaging Agents and Biotherapeutics”. This special Advanced Drug Delivery Reviews issue summarizes recent progress and different applications of chitosanbased formulations.
Amidi, M., Hennink, W.E.
openaire   +2 more sources

Modeling and prediction of excipient and pH drifts during ultrafiltration/diafiltration of monoclonal antibody biotherapeutic for high concentration formulations

Separation and Purification Technology, 2020
Abstract High concentration formulation is advantageous over conventionally used intravenous formulation. A model for the drift in the excipient concentration in the ultrafiltration/diafiltration (UF/DF) operation by including the flux of each of the species through the membrane module of the system was developed.
Vishwanath Hebbi   +2 more
exaly   +2 more sources

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