8:30 am Registration & Morning Coffee
Maintaining Homogenous DAR With Site-Specific Conjugation Technologies
9:30 am Approaches for Data-Driven Research in Animal Cell Culture Process Development
Synopsis
- Sharing examples of applying machine learning analysis to the process development of animal cell culture for antibody manufacturing
- Exploring how to promote data utilization, Daiichi Sankyo have built a cloud-based system for automatically collecting culture-related data
- Discussing how to expand culture profile data that may affect antibody quality, they obtained comprehensive cell culture profile data via Raman spectral analysis
10:00 am Analytical Strategies for Identifying & Characterizing Off-Target Conjugation in ADC Process Development
Synopsis
- Determine DAR distribution using chromatographic approaches
- Examine differences between broad and site-selective conjugation
- Develop advanced mass spectrometric assays to localize sites of off-target conjugation
10:30 am Morning Break
11:30 am Overcoming DAR Variability From an Unspecified Raw Material Impurity
Synopsis
Session details to be announced
12:00 pm Development of a High-Throughput Mass Spectrometry Method to Support ADC Conjugation Process Development
Synopsis
Session details to be announced
12:30 pm Networking Lunch
Advancing Drug Product Process Development for Stability & Efficiency
1:30 pm Accelerated Process Development & Establishment of Analytical Comparability of a Vial Size Change of a Lyophilized ADC Drug Product
Synopsis
- Discovering how vial size was reduced pre-validation to meet overfill compliance following an administration change
- Sharing how a new lyophilization cycle for the smaller vial was developed rapidly using process modeling and lean experimental design
- Outlining how elevated moisture in the smaller vial posed comparability risks and reviewing the mechanistic studies and analytical bridging enabled validation and regulatory alignment
2:00 pm Panel Discussion: Drug Product Final Dosage Form/SKU Considerations vs. Clinical Dose Strategies From The Drug Product Development Perspective
Synopsis
- How to configure drug product final dosage form for a wide range dose in clinical trials in phase 1?
- What triggers dosage form changes or addition in later phase development/commercialization? What are the typical challenges?
- How to set drug product specifications when the projected clinical dose range is wide?