8:00 Check-In & Coffee
8:50 am Chairs Opening Remarks
Navigating the Regulatory Landscape: Setting Specifications, CQAs & Analytical Methods From Discovery to Clinical Development & Filing
9:00 am Extended Characterization Study Package to Identify Critical Quality Attributes
Synopsis
- Designing comprehensive characterization studies, including forced degradation assessments, to evaluate critical quality attributes of ADCs and build a robust control strategy
- Identifying and characterizing conjugatable impurities from drug-linker systems, correlating their impact on product quality, and supporting process characterization
- Developing and implementing control strategies informed by forced degradation studies and impurity characterization insights
9:30 am Control Strategies for Impurities in Linker Drug Based on Conjugatability
Synopsis
- Determining a control strategy for impurities in the drug-linker intermediate
- Considering whether these impurities can conjugate to the antibody intermediate
- Addressing the gap in the literature on how to determine impurity conjugatability in a systematic and tiered-based approach beyond the presence of the intact conjugation motif in the impurity
- Establishing a strategy using our in-house drug-linker intermediate, first via high resolution MS/MS
10:00 am Session Reserved for Genovis
10:30 Morning Break & Speed Networking
11:30 am Understanding the Approaches to Extended Characterization; Evaluating the Regulatory Needs & Expectations
Synopsis
- Identifying key attributes for extended characterization of ADCs, such as drugto-antibody ratio, conjugate stability, and impurity profiles, and aligning them with regulatory expectations
- Evaluating advanced analytical methods (e.g., mass spectrometry, bioassays) that improve the accuracy of structural and functional characterization to meet detailed regulatory requirements
- Reviewing global regulatory expectations for data depth in ADC characterization, focusing on aligning extended characterization data with compliance standards for safety and efficacy
12:00 pm ADC CMC Excellence: Navigating Phase-Appropriate Regulatory and Analytical Strategies through CDMO-Biotech Collaboration
Synopsis
- Analytical Excellence: Strategies for analytical and regulatory quality in building the analytical approach
- Phase-Specific Strategies: Striking a balance between early-phase flexibility and late-phase compliance, with a focus on robust impurity control strategies
- CDMO-Biotech Integration: key considerations in technology transfers and development approaches
12:30 Lunch Break & Networking
1:30 pm Roundtable Discussion – Establishing Global Differences Between Regulatory Requirements for ADC Analytical Development
Synopsis
- Analyzing regional variations in regulatory requirements for ADC analytical development, focusing on critical aspects such as potency, stability, and safety assessments
- Exploring strategies for adapting analytical methods to meet differing global standards, aiming to streamline approval processes across multiple regulatory bodies
- Identifying challenges in validation and reporting requirements across regions, with a focus on achieving consistency and compliance in global ADC development
1:31 pm
Optimizing Potency Assay Approaches to Improve Readout Times & Understanding of Functionality
2:15 pm Enhancing Accuracy & Consistency in Potency Assays for GMP Release & Stability Testing
Synopsis
- Examining innovative methods to enhance sensitivity and reproducibility in potency assays, minimizing variability to ensure reliable results across batches
- Discussing best practices for potency assay validation, focusing on meeting regulatory standards to streamline approvals and uphold GMP standards
- Exploring strategies to optimize stability testing methods, aiming to provide more accurate insights into product longevity and ensure consistent potency throughout shelf life
2:45 pm Developing Bioassays for ADC
Synopsis
- Reviewing ADC bioassay development strategies
- Highlighting pitfalls and surprises experienced
- Introducing case studies for bioassay development
3:15 Afternoon Break
3:45 pm Cell Line Engineering & Screening Approaches for Improved Cytotoxicity Assay Performance
Synopsis
- Session details to be announced
4:15 pm Simultaneous Ultra-Sensitive Characterization & Quantification of Antibodies & ADCs in Biological Matrices
Synopsis
- Developing a hybrid LC-MS/MS method for quantification of ADCs
- Establishing and optimizing an affinity-based capture from biological matrices
- Detecting and quantifying total antibody and ADC concentrations simultaneously
4:45 pm Engineered Cell Lines vs. Cancer Cell Lines for Conventional Antibody-Drug Conjugate (ADC) Cell-Based Potency Assay Development
Synopsis
- Testing ADC potency through cytotoxicity assays, evaluating the tumor-killing activity of the payload following antibody internalization
- Ensuring assay robustness and specificity through the selection of a target antigen-expressing cell line