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. For drug developers, ADCs present a significant growth opportunity, with the market expected to expand from $6.8 billion to $15.4 billion between 2024 and 2029.
This white paper presents Lonza's integrated end-to-end approach to enhance ADC development and manufacturing, addressing common challenges in the industry.
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Cytotoxic drug product capabilities
First, we delve into Lonza's new drug product (DP) capabilities in cytotoxic drug development and manufacturing. These enhancements fully complete Lonza's integrated ADC offering and enable acceleration of the timeline to investigational new drug (IND) filing and beyond. The establishment of new fill and finish lines in Basel and Stein, Switzerland, enables the production of pre-clinical and clinical ADC batches, ensuring comprehensive end-to-end solutions.
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.
ADC service portfolio
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.
Highlights
- Insights into new drug product capabilities
- Accelerated timelines with Ibex® Design ADC Program
- Enhanced service portfolio via Synaffix acquisition
These advancements underscore Lonza's dedication to providing integrated, efficient, and innovative solutions for ADC development and manufacturing, supporting the evolving needs of drug developers and contributing to the advancement of targeted cancer therapies.