Bioconjugates, especially Antibody-Drug Conjugates (ADCs), are revolutionizing targeted therapies, offering precise and effective treatments. But bringing these complex therapeutics to life requires strategic foresight and specialized expertise.
We sat down with Iwan Bertholjotti, our expert with over 30 years at Lonza and a pivotal role in its bioconjugates sector, to discuss the critical aspects of ADC development. In this exclusive Q&A, Iwan shares invaluable insights on everything from preclinical planning and the vital role of CDMOs to Lonza's strategic investments and the exciting impact of AI and machine learning. Dive in to understand how proactive decisions and cutting-edge innovations are shaping the future of ADCs.
Q: What is the significance of preclinical and clinical development in ADCs?
A: Preclinical and clinical development are critical to the success of ADCs, where early strategic decisions regarding manufacturability and scalability can make or break a project. Iwan Bertholjotti from Lonza emphasizes the importance of proactive planning to avoid costly delays and ensure smooth progress towards clinical success.
Q: What are bioconjugates and their role in targeted therapies?
A: Bioconjugates are rapidly emerging as a key frontier in targeted therapies, particularly through Antibody-Drug Conjugates (ADCs), which combine antibodies with cytotoxic drugs to deliver more precise and effective treatments. This fusion enables precise delivery of potent drugs directly to cancer cells or other targeted tissues, significantly improving the therapeutic impact while minimizing harm to healthy cells.
Q: What is the role of Contract Development and Manufacturing Organizations (CDMOs) in ADC development?
A: ADCs are powerful therapeutics but are notoriously complex to develop and manufacture. CDMOs like Lonza play a critical role by providing the diverse range of capabilities, safety protocols, and expertise required for ADC development. Around 70–80 percent of development and manufacturing in this field is outsourced to CDMOs.
Q: What strategic investments has Lonza made in ADC development?
A: Lonza has made several key investments to develop a comprehensive ADC offering, including expanding personnel, bolstering infrastructure, building bioconjugation suites and facilities, increasing mammalian capacity, and developing specialized assets for drug linkers. In 2023, Lonza acquired Synaffix, bringing new proprietary technologies into the fold and enabling site-specific conjugation technologies.
Q: How is machine learning and AI influencing ADC development at Lonza?
A: One of the exciting partnerships in Lonza’s ADC ecosystem is with BigHat Biosciences, a company at the forefront of AI-driven antibody design. This partnership blends Lonza’s manufacturing expertise with BigHat’s machine-learning platform for antibody engineering, helping to predict successful molecules earlier, reduce waste, and optimize the design-to-clinic pipeline.
Q: Why is preclinical planning critical for ADC success?
A: Preclinical development often lays the foundation for future success or failure. Early strategic planning regarding manufacturability and scalability is crucial to avoid delays. Lonza encourages its biotech partners to address these considerations from the very beginning to ensure seamless integration of all ADC development stages.
Q: What is the future outlook for ADCs and Lonza’s role in it?
A: As the therapeutic potential of ADCs expands across oncology and other areas, the demand for integrated, scalable, and innovative development platforms intensifies. With its growing capabilities, strategic acquisitions, and forward-thinking approach to AI, Lonza is set to stay at the forefront of this evolution, helping to define the next generation of ADCs.