Results 101 to 110 of about 1,377,424 (162)

An investigation into the effect of polysorbate 80 grade in biotherapeutic formulations

International Journal of Pharmaceutical Excipients
Polysorbate 80 is a commonly used excipient in the food, cosmetics and pharmaceutical industries. In pharmaceutical formulations, the only requirement in the British Pharmacopeia and US Pharmacopeia is for the composition to be ≥ 58% oleic acid ester ...
Gareth Williams, Sebastian J Gurgul
exaly   +4 more sources

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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
Patrick Garidel, Stefan Carle, Mridula Dwivedi   +2 more
exaly   +4 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
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 ...
Vishwanath Hebbi, Souhardya Roy, A. Rathore, A. Shukla   +3 more
semanticscholar   +2 more sources

Impact of Citrate on Mitigating Iron Mediated Polysorbate 80 Degradation in Biotherapeutic Formulation Placebos.

Journal of Pharmaceutical Sciences
Polysorbate 80 (PS80), a widely used polymeric surfactant in biotherapeutic formulation, possesses a unique structural composition that effectively prevents protein aggregation in highly concentrated protein drug formulations.
Rong-Sheng Yang, Chengbei Li, Liliana Henriquez, Hongxia Wang, Jainik Panchal, Wendy Zhong, H. Schuessler   +6 more
semanticscholar   +3 more sources

Biotherapeutic agents and vaginal health

Journal of Applied Microbiology, 2016
F. Al-Ghazzewi, R. Tester
exaly   +2 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, Patrick, Garidel, Blech, Michaela   +2 more
openaire   +2 more sources

High concentration biotherapeutic formulation and ultrafiltration: Part 1 pressure limits

Biotechnology Progress, 2017
High therapeutic dosage requirements and the desire for ease of administration drive the trend to subcutaneous administration using delivery systems such as subcutaneous pumps and prefilled syringes. Because of dosage volume limits, prefilled syringe administration requires higher concentration liquid formulations, limited to about
H. Lutz, J. Arias, Yuemei Zou
semanticscholar   +3 more sources

Solid-State NMR Characterization of Lyophilized Formulations of Monoclonal Antibody Therapeutics.

Molecular Pharmaceutics, 2023
Monoclonal antibodies (mAbs) are an important and growing class of biotherapeutic drugs. Method development for the characterization of critical quality attributes, including higher-order structure (HOS), of mAbs remains an area of active inquiry ...
Jacqueline R. Perodeau, Luke W. Arbogast, Andrew J. Nieuwkoop   +2 more
semanticscholar   +1 more source

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, Danika Rodrigues, Bo Zhai, Dwaine Banton, Sandeep Somani, Alex Javidi, Andrew Mahan, Stuart Ember, Dominick DeGrazio, Subinay Ganguly, Ketan Amin, Hirsh Nanda   +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