ValenzaBio, a biopharmaceutical company developing monoclonal antibody therapeutics for autoimmune and inflammatory indications, and Lonza announced that the companies have a manufacturing agreement in place.
This collaboration is aimed at manufacturing VB421, a potential best-in-class anti-insulin-like growth factor 1 receptor (anti-IGF-1R) antibody currently under evaluation for the treatment of thyroid eye disease (TED) and other inflammatory disorders. TED is an autoimmune disease causing eye-bulging and vision change with a risk of complete vision loss. VB421 is designed to bind IGF-1R, which is believed to play a central role in the pathogenesis of TED. VB421 is currently in an IND-enabling program to support first-in-human studies for the treatment of TED and other autoimmune and fibrotic diseases.
"The signing of the manufacturing agreement with ValenzaBio showcases our flexibility in supporting biotech companies of all sizes, and our focused commitment to enabling ValenzaBio to reach the full potential of their innovative therapies on accelerated timelines,” said Jennifer Cannon, Senior Vice President and Global Head of Mammalian Biologics at Lonza. ”We are excited that our new, state-of-the-art Biologics facility in Guangzhou, China will be employed for manufacturing of cGMP drug substance to help bring treatment to patients around the world who suffer from Thyroid Eye Disease (TED),"
Under the terms of the agreement, Lonza will leverage its global network and local operation capabilities to provide ValenzaBio with clinical materials’ supply. The scope will include drug substance (DS) manufacturing at Lonza’s new state-of-the-art cGMP mammalian facility in Guangzhou, China as well as management of drug product manufacturing.
The main production platform will utilize Lonza's GS Xceed® Expression System, which is highly recognized in the industry and covers various techniques and commercialized processes such as host cells, expression vectors and optimized culture media.
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