Accelerated aggregation studies of monoclonal antibodies: considerations for storage stability

R Wälchli, PJ Vermeire, J Massant, P Arosio - Journal of pharmaceutical …, 2020 - Elsevier
Aggregation of mAbs is a crucial concern with respect to their safety and efficacy. Among the
various properties of protein aggregates, it is emerging that their size can potentially impact …

Evaluation of a non-Arrhenius model for therapeutic monoclonal antibody aggregation

V Kayser, N Chennamsetty, V Voynov, B Helk… - Journal of …, 2011 - Elsevier
Understanding antibody aggregation is of great significance for the pharmaceutical industry.
We studied the aggregation of five different therapeutic monoclonal antibodies (mAbs) with …

Orthogonal techniques to study the effect of pH, sucrose, and arginine salts on monoclonal antibody physical stability and aggregation during long-term storage

HL Svilenov, A Kulakova, M Zalar… - Journal of …, 2020 - Elsevier
Understanding the effects of additives on therapeutic protein stability is of paramount
importance for obtaining stable formulations. In this work, we apply several high-and …

Predicting accelerated aggregation rates for monoclonal antibody formulations, and challenges for low-temperature predictions

RK Brummitt, DP Nesta, CJ Roberts - Journal of pharmaceutical sciences, 2011 - Elsevier
Nonnative aggregation is a common degradation route for therapeutic proteins. Control of
aggregate levels inherently requires control and/or prediction of aggregation rates at …

High throughput prediction approach for monoclonal antibody aggregation at high concentration

M Zidar, A Šušterič, M Ravnik, D Kuzman - Pharmaceutical research, 2017 - Springer
Purpose Characterization of the monoclonal antibody aggregation process and identification
of stability factors that could be used as indicators of aggregation propensity with an …

Mapping the aggregation kinetics of a therapeutic antibody fragment

N Chakroun, D Hilton, SS Ahmad, GW Platt… - Molecular …, 2016 - ACS Publications
The analytical characterization of biopharmaceuticals is a fundamental step in the early
stages of development and prediction of their behavior in bioprocesses. Protein aggregation …

Analytical platform for monitoring aggregation of monoclonal antibody therapeutics

R Bansal, S Gupta, AS Rathore - Pharmaceutical Research, 2019 - Springer
Purpose To develop an analytical platform for the estimation as well as characterization of
aggregates over the complete size spectrum (from invisible monomer to visible precipitates) …

High throughput formulation screening for global aggregation behaviors of three monoclonal antibodies

Y Li, H Mach, JT Blue - Journal of pharmaceutical sciences, 2011 - Elsevier
Global aggregation behaviors of three distinct monoclonal antibodies were characterized by
high throughput, multiassay analysis. First, extensive screening of formulations was …

Examination of thermal unfolding and aggregation profiles of a series of developable therapeutic monoclonal antibodies

ML Brader, T Estey, S Bai, RW Alston… - Molecular …, 2015 - ACS Publications
Screening for pharmaceutically viable stability from measurements of thermally induced
protein unfolding and short-term accelerated stress underpins much molecule design …

Effects of ionic strength and sugars on the aggregation propensity of monoclonal antibodies: influence of colloidal and conformational stabilities

S Saito, J Hasegawa, N Kobayashi, T Tomitsuka… - Pharmaceutical …, 2013 - Springer
Purpose To develop a general strategy for optimizing monoclonal antibody (MAb)
formulations. Methods Colloidal stabilities of four representative MAbs solutions were …