Molecular and functional analysis of monoclonal antibodies in support of biologics development

X Wang, Z An, W Luo, N Xia, Q Zhao - Protein & cell, 2018 - academic.oup.com
Monoclonal antibody (mAb)-based therapeutics are playing an increasingly important role in
the treatment or prevention of many important diseases such as cancers, autoimmune …

Analytical techniques for the characterization and quantification of monoclonal antibodies

HA Alhazmi, M Albratty - Pharmaceuticals, 2023 - mdpi.com
Monoclonal antibodies (mAbs) are a fast-growing class of biopharmaceuticals. They are
widely used in the identification and detection of cell makers, serum analytes, and …

Biosimilar monoclonal antibodies: a science-based regulatory challenge

PJ Declerck - Expert opinion on biological therapy, 2013 - Taylor & Francis
Monoclonal antibodies (MAs) are complex biotherapeutics as their molecular mechanism of
action depends on multiple domains. Consequently regulatory approval of biosimilars of …

Monoclonal antibodies-regulatory challenges

CK Schneider - Current pharmaceutical biotechnology, 2008 - ingentaconnect.com
The development of new monoclonal antibodies (mAbs) is a still evolving field in finding new
therapeutics. Structurally, mAbs have evolved over the past years by change from fully …

[PDF][PDF] Biosimilar monoclonal antibodies: preclinical and clinical development aspects

J Gonçalves, F Araújo, M Cutolo… - Clin Exp …, 2016 - clinexprheumatol.org
Biological drugs and their originated biosimilars are large, highly complex molecules
derived from living cells or organisms. Traditional medicines, by contrast, are usually simple …

The state-of-play and future of antibody therapeutics

Z Elgundi, M Reslan, E Cruz, V Sifniotis… - Advanced drug delivery …, 2017 - Elsevier
It has been over four decades since the development of monoclonal antibodies (mAbs)
using a hybridoma cell line was first reported. Since then more than thirty therapeutic …

Maintaining 'standards' for biosimilar monoclonal antibodies

S Prior, C Metcalfe, SE Hufton, M Wadhwa… - Nature …, 2021 - nature.com
To the Editor—The debate concerning biosimilar monoclonal antibodies (mAbs) has
matured over the past 10 years. During the early 2000s, it centered on (i) whether …

[HTML][HTML] Quality, non-clinical and clinical considerations for biosimilar monoclonal antibody development: EU, WHO, USA, Canada, and BRICS-TM regulatory …

H Rahalkar, HC Cetintas, S Salek - Frontiers in Pharmacology, 2018 - frontiersin.org
Objective: The aim was to critically evaluate well-established regulatory agencies mAb
biosimilar guidelines for development and marketing authorization about quality, efficacy …

Toward biosimilar monoclonal antibodies

CK Schneider, U Kalinke - Nature biotechnology, 2008 - nature.com
Toward biosimilar monoclonal antibodies | Nature Biotechnology Skip to main content Thank
you for visiting nature.com. You are using a browser version with limited support for CSS. To …

[HTML][HTML] Biosimilarity assessment of biosimilar therapeutic monoclonal antibodies

A Ishii-Watabe, T Kuwabara - Drug metabolism and pharmacokinetics, 2019 - Elsevier
The concept of biosimilar was established in the early 2000s in EU. Currently, the regulatory
framework for biosimilar has also been established in the US, Japan, and other countries. As …