Regulatory considerations in the design, development and quality of monoclonal antibodies and related products for the diagnosis and treatment of cancer

M Shapiro - Frontiers in Oncology, 2024 - frontiersin.org
Over 160 therapeutic and in vivo diagnostic monoclonal antibodies have been approved by
the US FDA since the first monoclonal antibody, muromonab, was approved in 1986 …

Monoclonal antibodies: Trends in therapeutic success and commercial focus

MS Kinch, Z Kraft, T Schwartz - Drug Discovery Today, 2023 - Elsevier
Highlights•More than 100 new experimental antibodies now enter into development each
year.•Half of experimental monoclonal antibodies and a third of approvals are potential …

Monoclonal antibodies as innovative therapeutics

JM Reichert - Current pharmaceutical biotechnology, 2008 - ingentaconnect.com
Monoclonal antibodies (mAbs) comprise the majority of protein candidates currently in
clinical development because of their versatility as therapeutic agents. While traditionally …

Monoclonal antibodies in cancer

A Grimsley, KS Shah, T McKibbin - … Biotechnology: Fundamentals and …, 2013 - Springer
Cancer is the second leading cause of death in the United States with one of every four
deaths attributable to cancer (Jemal et al. 2006). The first references to cancer date back to …

Development and regulation of monoclonal antibody products: challenges and opportunities

WC Weinberg, MR Frazier-Jessen, WJ Wu… - Cancer and metastasis …, 2005 - Springer
An increasing number of monoclonal antibodies for cancer diagnosis and treatment are in
clinical use and in the development pipeline, with more expected as new molecular targets …

Current perspectives on therapeutic antibodies

S Yoon, YS Kim, H Shim, J Chung - Biotechnology and bioprocess …, 2010 - Springer
Since the first monoclonal antibody, muromonab-CD3, was approved for therapeutic use in
1986, numerous molecules have been targeted using therapeutic antibody technology …

Monoclonal antibody therapeutics: history and future

NAPS Buss, SJ Henderson, M McFarlane… - Current opinion in …, 2012 - Elsevier
Over the last three decades, monoclonal antibodies have made a dramatic transformation
from scientific tools to powerful human therapeutics. At present, approximately 30 …

[PDF][PDF] Monoclonal antibodies for cancer therapy

V Rayzman, A Scott - Cancer Forum, 2002 - researchgate.net
A large number of monoclonal antibodies (mAbs) are currently under investigation for the
treatment of malignant diseases. To date, a significant amount of experimental and clinical …

Practical considerations for nonclinical safety evaluation of therapeutic monoclonal antibodies

CM Lynch, BW Hart, IS Grewal - MAbs, 2009 - Taylor & Francis
Monoclonal antibodies (mAbs) are a well established class of therapeutics as evidenced by
a large number of FDA approved mAbs for the treatment of cancers and autoimmune …

The future of monoclonal antibody technology

A Zider, D Drakeman - MAbs, 2010 - Taylor & Francis
With the rapid growth of monoclonal antibody-based products, new technologies have
emerged for creating modified forms of antibodies, including fragments, conjugates and …