The 4th ADC Analytical Development Summit introduces a renewed focus on refining analytical techniques to address the evolving demands of ADC development. As regulatory expectations increase and product complexity grows, the summit will offer actionable insights into enhancing existing methodologies. Sessions will cover a range of topics, from optimizing DAR quantification and improving aggregation analysis to refining impurity profiling. These discussions are designed to equip attendees with the precise tools needed to ensure the development of robust, high-quality ADC products.
What You’ll Gain:
Participants will leave equipped with best practices for ensuring ADC product quality and aligning with stringent regulatory requirements. Through in-depth discussions and case studies, you will gain practical solutions to analytical challenges such as DAR quantification, aggregation measurement, and impurity analysis. This is also an opportunity to benchmark your approaches against industry peers and stay competitive in the rapidly advancing ADC landscape.
Join us to refine your analytical strategies, ensure compliance, and deliver safe, effective ADC products to patients in need. Don’t miss the chance to enhance your expertise and drive success in ADC development.
Join Your Peers to:
Explore Advances in ADC Characterization
Explore advanced analytical techniques like LC-MS, SEC, and HIC to gain insights into ADC quality attributes. These methods enable precise analysis of DAR distributions, structural integrity, and stability, ensuring consistent product quality. Leveraging these approaches enhances ADC characterization, efficacy, and safety, leading to successful clinical outcomes.
Optimize Potency & Cell-Based Assays
Refine your potency and cell-based assay strategies to enhance sensitivity and reproducibility. Learn to design standardized protocols that align with GMP standards, reduce assay variability, and deliver reliable data for ADC development. These improvements are crucial for ensuring accurate potency readouts and confidently supporting regulatory submissions.
Stay Ahead with Cutting-Edge Analytical Strategies
Gain expertise in developing phase-appropriate analytical methods for ADC development, from preclinical research to BLA submission. Discover techniques to enhance data accuracy, streamline regulatory approvals, and ensure commercialization readiness. Fine-tuning your approaches can significantly impact the efficiency and success of your ADC program.
Master Regulatory Insights Across Regions
Understand the evolving global regulatory landscape for ADCs, focusing on EU and US guidelines. Learn to align your analytical strategies with regional expectations to ensure compliance and accelerate approval timelines. Mastering these regulatory nuances will help you navigate the complexities of global ADC development with confidence.
Connect with Industry Leaders & Innovators
Engage with analytical development experts from leading biotech and pharmaceutical companies through workshops, roundtables, and case study discussions. Exchange insights and collaborate on solutions to overcome key challenges in ADC analytics. Build connections that drive innovation and success in your ADC programs.
Who Will You Meet?
Over 120 professionals from analytical development, CMC, quality control, and technical operations
