Physicochemical stability of monoclonal antibodies: a review

Y Le Basle, P Chennell, N Tokhadze, A Astier… - Journal of …, 2020 - Elsevier
Monoclonal antibodies (mAbs) are subject to instability issues linked to their protein nature.
In this work, we review the different mechanisms that can be linked to monoclonal antibodies …

Histidine as a versatile excipient in the protein-based biopharmaceutical formulations

JY Lv, RG Ingle, H Wu, C Liu, WJ Fang - International Journal of …, 2024 - Elsevier
Adequate stabilization is essential for marketed protein-based biopharmaceutical
formulations to withstand the various stresses that can be exerted during the pre-and post …

Understanding the stabilizing effect of histidine on mAb aggregation: a molecular dynamics study

S Saurabh, C Kalonia, Z Li, P Hollowell… - Molecular …, 2022 - ACS Publications
Histidine, a widely used buffer in monoclonal antibody (mAb) formulations, is known to
reduce antibody aggregation. While experimental studies suggest a nonelectrostatic …

A review of tangential flow filtration: process development and applications in the pharmaceutical industry

P Agrawal, K Wilkstein, E Guinn… - … Process Research & …, 2023 - ACS Publications
Tangential flow filtration is an efficient membrane separation technology utilized across a
wide range of industries for separation and purification applications. The requirement of …

Characterization of a novel ACE2-based therapeutic with enhanced rather than reduced activity against SARS-CoV-2 variants

M Ferrari, L Mekkaoui, FT Ilca, Z Akbar… - Journal of …, 2021 - Am Soc Microbiol
The human angiotensin-converting enzyme 2 acts as the host cell receptor for SARS-CoV-2
and the other members of the Coronaviridae family SARS-CoV-1 and HCoV-NL63. Here, we …

Stability testing in monoclonal antibodies

H Kaur - Critical Reviews in Biotechnology, 2021 - Taylor & Francis
Monoclonal antibodies are proteinaceous in nature and are subject to instability issues.
Stability testing of monoclonal antibodies is a critical regulatory requirement in their …

Studying excipient modulated physical stability and viscosity of monoclonal antibody formulations using small-angle scattering

AY Xu, MM Castellanos, K Mattison… - Molecular …, 2019 - ACS Publications
Excipients are substances that are added to therapeutic products to improve stability,
bioavailability, and manufacturability. Undesirable protein–protein interactions (PPI) can …

In silico prediction of post-translational modifications in therapeutic antibodies

S Vatsa - MAbs, 2022 - Taylor & Francis
Monoclonal antibodies are susceptible to chemical and enzymatic modifications during
manufacturing, storage, and shipping. Deamidation, isomerization, and oxidation can …

Development of mAb-loaded 3D-printed (FDM) implantable devices based on PLGA

E Carlier, S Marquette, C Peerboom, K Amighi… - International journal of …, 2021 - Elsevier
The main objective of this work was to explore the feasibility to print monoclonal antibody
(mAb)-loaded implantable systems using fused-deposition modelling (FDM) to build …

Flow activation energy of high-concentration monoclonal antibody solutions and protein–protein interactions influenced by NaCl and sucrose

G Yuan, PF Salipante, SD Hudson… - Molecular …, 2024 - ACS Publications
The solution viscosity and protein–protein interactions (PPIs) as a function of temperature (4–
40° C) were measured at a series of protein concentrations for a monoclonal antibody (mAb) …