Oxidation and deamidation of monoclonal antibody products: potential impact on stability, biological activity, and efficacy

S Gupta, W Jiskoot, C Schöneich, AS Rathore - Journal of pharmaceutical …, 2022 - Elsevier
The role in human health of therapeutic proteins in general, and monoclonal antibodies
(mAbs) in particular, has been significant and is continuously evolving. A considerable …

Instability of therapeutic proteins—An overview of stresses, stabilization mechanisms and analytical techniques involved in Lyophilized proteins

A Butreddy, KY Janga, S Ajjarapu, S Sarabu… - International journal of …, 2021 - Elsevier
Solid-state is the preferred choice for storage of protein therapeutics to improve stability and
preserve the biological activity by decreasing the physical and chemical degradation …

Chemical and physical instabilities in manufacturing and storage of therapeutic proteins

ME Krause, E Sahin - Current opinion in biotechnology, 2019 - Elsevier
Highlights•Proteins undergo spontaneous degradation during manufacturing and
storage.•Chemical modifications to proteins can influence physical stability.•Predictive tools …

Science and art of protein formulation development

W Wang, S Ohtake - International journal of pharmaceutics, 2019 - Elsevier
Protein pharmaceuticals have become a significant class of marketed drug products and are
expected to grow steadily over the next decade. Development of a commercial protein …

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 …

Machine learning enables accurate prediction of asparagine deamidation probability and rate

JA Delmar, J Wang, SW Choi, JA Martins… - … Therapy-Methods & …, 2019 - cell.com
The spontaneous conversion of asparagine residues to aspartic acid or iso-aspartic acid, via
deamidation, is a major pathway of protein degradation and is often seriously disruptive to …

A novel method for in silico assessment of Methionine oxidation risk in monoclonal antibodies: Improvement over the 2-shell model

D Tavella, DR Ouellette, R Garofalo, K Zhu, J Xu… - PLoS …, 2022 - journals.plos.org
Over the past decade, therapeutic monoclonal antibodies (mAbs) have established their role
as valuable agents in the treatment of various diseases ranging from cancers to infectious …

Stability of protein pharmaceuticals: Recent advances

MC Manning, RE Holcomb, RW Payne… - Pharmaceutical …, 2024 - Springer
There have been significant advances in the formulation and stabilization of proteins in the
liquid state over the past years since our previous review. Our mechanistic understanding of …

[HTML][HTML] Engineering stability, viscosity, and immunogenicity of antibodies by computational design

D Kuroda, K Tsumoto - Journal of Pharmaceutical Sciences, 2020 - Elsevier
In recent years, computational methods have garnered much attention in protein
engineering. A large number of computational methods have been developed to analyze the …

Prediction of methionine oxidation risk in monoclonal antibodies using a machine learning method

K Sankar, KH Hoi, Y Yin, P Ramachandran… - MAbs, 2018 - Taylor & Francis
Monoclonal antibodies (mAbs) have become a major class of protein therapeutics that target
a spectrum of diseases ranging from cancers to infectious diseases. Similar to any protein …