Filling the Need for Integrated Bioconjugate Solutions
Antibody drug conjugates (ADCs) are revolutionizing cancer therapy with their highly specific mechanism of action, offering new hope to cancer patients worldwide. To date, 14 ADCs have received market approval to treat various cancers, and over 200 are currently in clinical development.
This Q&A is an extension of our webinar on Ibex® Design ADC and expands on how the enhanced ADC portfolio through new highly potent Drug Product capabilities and Synaffix technologies can benefit your ADC and other bioconjugates programs. Learn about programs timeline, scope and flexible entry points.
Get immediate access to the Q&A by filling out the form on this page.
ADC Drug Product New Capabilities
Lonza's new drug product (DP) capabilities in highly potent biologics drug development and manufacturing complete Lonza's ADC offering. The establishment of non-cGMP and GMP filling lines in Switzerland at Basel and Stein sites, respectively, enables the production of pre-clinical, clinical and small commercial ADC batches, ensuring comprehensive end-to-end solutions. The highly contained vial filling line at Stein, equipped with lyophilization technology, enables drug product tech transfers for your integrated or stand-alone programs to accelerate and maximize CMC success for investigational new drug (IND) or biologics license application (BLA) filings.
Synaffix Acquisition
Lonza's ADC capabilities support drug development from early-phase clinical studies to commercialization. The acquisition of Synaffix has enhanced Lonza's ADC service portfolio with advanced payloads, linkers, and state-of-the-art conjugation technology, providing a robust and flexible suite of services to ADC developers.
Lonza's Ibex® Design ADC program
The Ibex® Design ADC program is a cornerstone of Lonza's strategy to speed up ADC development while optimizing quality. This program enables the delivery of drug products (DP) in an industry-leading 15 months and drug substances (DS) for toxicology studies in just 8 months. This accelerated timeline allows ADC drug developers to progress according to their own milestones and risk profiles. Additionally, it includes the delivery of submission-ready Chemistry, Manufacturing, and Controls (CMC) data for IND filing, further streamlining the process.