- Lonza will deliver a program tailored to ValenzaBio’s needs to enable first-in-human clinical studies
- Lonza will provide drug substance and drug product manufacturing under accelerated timelines
- Drug substance manufacturing to be carried out in state-of-the-art cGMP mammalian manufacturing facility in Guangzhou (CN)
Quote from Jennifer Cannon, Senior Vice President, Global Head of Mammalian Biologics, Lonza:
"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. 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)."
Quote from Tatyana Touzova, Chief Operating Officer, ValenzaBio:
"As we prepare to advance VB421 into clinical studies for autoimmune diseases, including Thyroid Eye Disease (TED), in the first half of next year, we are pleased to have Lonza, a global leader in antibody manufacturing, as our trusted partner. Lonza has the knowledge, systems, and production capacity in place to proceed with optimal efficiency during these difficult times for global supply chains. Securing reliable biomanufacturing is a significant challenge for many smaller biopharmaceutical companies. We are grateful to be able to advance the VB421 program immediately in Lonza's new state-of-the-art manufacturing facility."
Maryland, USA and Basel, Switzerland, 18 June 2021 – ValenzaBio, a biopharmaceutical company developing monoclonal antibody therapeutics for autoimmune and inflammatory indications, and Lonza announced today 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.
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 (CN) 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.