Not the usual suspects: Alternative surfactants for biopharmaceuticals

S Brosig, S Cucuzza, T Serno… - … applied materials & …, 2023 - ACS Publications
Therapeutically relevant proteins naturally adsorb to interfaces, causing aggregation which
in turn potentially leads to numerous adverse consequences such as loss of activity or …

Characterization of recombinantly-expressed hydrolytic enzymes from chinese hamster ovary cells: identification of host cell proteins that degrade polysorbate

D Kovner, IH Yuk, A Shen, H Li, T Graf, S Gupta… - Journal of …, 2023 - Elsevier
Enzymatic hydrolysis of polysorbate in drug products is a major challenge for the
biopharmaceutical industry. Polysorbate hydrolysis caused by host cell proteins (HCPs) co …

A Review of Polysorbate Quantification and its Degradation Analysis by Liquid Chromatography Coupled with Charged Aerosol Detection

L Shi, G Shen, R Chai, PH Gamache, Y ** - Journal of Chromatography A, 2024 - Elsevier
Abstract Polysorbates (PS), as non-ionic surfactants, contribute significantly to the stability of
proteins in formulations. However, their lack of chromophore groups makes them difficult to …

Existence of a superior polysorbate fraction in respect to protein stabilization and particle formation?

T Diederichs, JJ Mittag, J Humphrey, S Voss… - International Journal of …, 2023 - Elsevier
Biologicals including monoclonal antibodies are the current flagships in pharmaceutical
industry. However, they are exposed to a multitude of destabilization conditions like for …

End-to-end approach to surfactant selection, risk mitigation, and control strategies for protein-based therapeutics

AM Morales, A Sreedhara, J Buecheler, S Brosig… - The AAPS journal, 2022 - Springer
A survey performed by the AAPS Drug Product Handling community revealed a general,
mostly consensus, approach to the strategy for the selection of surfactant type and level for …

Guanidine-modified albumin-MMAE conjugates with enhanced endocytosis ability

C Yi, F ** stable biopharmaceutical formulations is of paramount importance and is
typically achieved by incorporating surfactants as stabilising agents, such as polysorbate 20 …

[HTML][HTML] Enzymatic degradation pattern of polysorbate 20 impacts interfacial properties of monoclonal antibody formulations

K Gregoritza, C Theodorou, M Heitz, T Graf… - European Journal of …, 2024 - Elsevier
Abstract Polysorbate 20 (PS20) is widely used to maintain protein stability in
biopharmaceutical formulations. However, PS20 is susceptible to hydrolytic degradation …

[HTML][HTML] High throughput FAMS–A fatty acid mass spectrometry method for monitoring polysorbate hydrolysis in QC

S Hoelterhoff, J Wendler, L Arackal, B Felkel… - … of Chromatography B, 2023 - Elsevier
Surfactant degradation in biopharmaceuticals has recently gained significant attention in the
pharmaceutical industry. Specifically, hydrolytic degradation of polysorbates, leading to the …