Poloxamer 188 as surfactant in biological formulations–An alternative for polysorbate 20/80?
L Bollenbach, J Buske, K Mäder, P Garidel - International Journal of …, 2022 - Elsevier
Surfactants are used to stabilize biologics. Particularly, polysorbates (Tween® 20 and
Tween® 80) dominate the group of surfactants in protein and especially antibody drug …
Tween® 80) dominate the group of surfactants in protein and especially antibody drug …
Pluronic F-68 and F-127 based nanomedicines for advancing combination cancer therapy
Pluronics are amphiphilic triblock copolymers composed of two hydrophilic poly (ethylene
oxide)(PEO) chains linked via a central hydrophobic polypropylene oxide (PPO). Owing to …
oxide)(PEO) chains linked via a central hydrophobic polypropylene oxide (PPO). Owing to …
Surface-induced protein aggregation and particle formation in biologics: current understanding of mechanisms, detection and mitigation strategies
Protein stability against aggregation is a major quality concern for the production of safe and
effective biopharmaceuticals. Amongst the different drivers of protein aggregation …
effective biopharmaceuticals. Amongst the different drivers of protein aggregation …
Alternative excipients for protein stabilization in protein therapeutics: overcoming the limitations of polysorbates
AJ Castañeda Ruiz, MA Shetab Boushehri, T Phan… - Pharmaceutics, 2022 - mdpi.com
Given their safety and efficiency in protecting protein integrity, polysorbates (PSs) have been
the most widely used excipients for the stabilization of protein therapeutics for years. In …
the most widely used excipients for the stabilization of protein therapeutics for years. In …
A systematic review of commercial high concentration antibody drug products approved in the US: formulation composition, dosage form design and primary …
I Ghosh, H Gutka, ME Krause, R Clemens, RS Kashi - MAbs, 2023 - Taylor & Francis
Three critical aspects that define high concentration antibody products (HCAPs) are as
follows: 1) formulation composition, 2) dosage form, and 3) primary packaging configuration …
follows: 1) formulation composition, 2) dosage form, and 3) primary packaging configuration …
Industry perspective on the use and characterization of polysorbates for biopharmaceutical products part 2: survey report on control strategy preparing for the future
K Wuchner, L Yi, C Chery, F Nikels, F Junge… - Journal of …, 2022 - Elsevier
Abstract Polysorbate (PS) 20 and 80 are the main surfactants used to stabilize
biopharmaceutical products. Industry practices on various aspects of PS based on a …
biopharmaceutical products. Industry practices on various aspects of PS based on a …
[HTML][HTML] Particles in biopharmaceutical formulations, part 2: an update on analytical techniques and applications for therapeutic proteins, viruses, vaccines and cells
A Roesch, S Zölls, D Stadler, C Helbig… - Journal of …, 2022 - Elsevier
Particles in biopharmaceutical formulations remain a hot topic in drug product development.
With new product classes emerging it is crucial to discriminate particulate active …
With new product classes emerging it is crucial to discriminate particulate active …
Polysorbate degradation and particle formation in a high concentration mAb: formulation strategies to minimize effect of enzymatic polysorbate degradation
I Roy, A Patel, V Kumar, T Nanda, R Assenberg… - Journal of …, 2021 - Elsevier
Abstract Polysorbate (PS) 20 and 80 are the most common surfactants in monoclonal
antibody (mAb) drug product (DP) formulations. Residual host cell proteins (HCP) present at …
antibody (mAb) drug product (DP) formulations. Residual host cell proteins (HCP) present at …
[HTML][HTML] Size shifting of solid lipid nanoparticle system triggered by alkaline phosphatase for site specific mucosal drug delivery
We aim to prepare a size-shifting nanocarrier for site-targeting mucosal drug delivery that
can penetrate through mucus gel layer and remain close to the absorption membrane. As …
can penetrate through mucus gel layer and remain close to the absorption membrane. As …
Adsorption and aggregation of monoclonal antibodies at silicone oil–water interfaces
Monoclonal antibody (mAb) therapies are rapidly growing for the treatment of various
diseases like cancer and autoimmune disorders. Many mAb drug products are sold as …
diseases like cancer and autoimmune disorders. Many mAb drug products are sold as …