8:00 am Check-In & Coffee
8:50 am Chair’s Opening Remarks
Ensuring High & Consistent Drug Substance Quality to Adhere to ADC Regulatory Control Strategies
9:00 am Highlighting the Specific Critical Quality Attributes for an Acceptable ADC From a Regulatory Stance
Synopsis
- Overviewing the specific criteria required by regulatory agencies such as average time to manufacturing, stability, DAR and cytotoxicity of your ADC
- Understanding the limit of active substance impurities such as linker-payload and mAb
- Delving into the control strategies for ADCs to understand which quality attributes to start with in process development
9:30 am Comprehending & Facing Regulatory Approval Challenges to Overcome Hurdles in ADC Scale-Up Processes
Synopsis
- Exploring real life approved ADC case studies to understand the lessons learnt from adjusting processes to regulatory requirements
- Setting wide enough specifications for scale up, which still fall within regulatory acceptance criteria of impurity limits
- Understanding the regulatory frameworks for speeding up time to manufacturing
10:00 am Morning Break & Speed Networking
Synopsis
This informal session will provide the process development community valuable networking time, enabling you to forge new and lasting connections to plot paths to see future successes within the field.
11:00 am Session Reserved for BSP Pharmaceuticals
11:15 am CMC Regulatory Considerations for Setting Small Molecule Impurity & Control Strategies
Synopsis
- Understanding the regulatory frameworks for an ADC to reflect the production processes and the combined approach to quality
- Justifying the specification setting for small molecule impurity limits
- Regulatory benchmarking of critical quality attributes and control strategies for marketed ADC products
11:45 am Roundtable Discussion – Setting Optimal CQAs to Ensure Appropriate Impurity Removal & Achieve Regulatory Approval
Synopsis
- Discussing standardized general control strategy for ADCs
- Understanding what the “must-do” aspects of process development are, and what can be deferred for IND approval, in order to improve cost and speed
12:30 pm Networking Lunch
Maximizing ADC Process Efficiency Through Unlocking Maximum Conjugation Yield
2:00 pm Panel Discussion – Optimizing Conjugation Processes to Decrease Heterogeneity & Prepare for Scale-Up
Synopsis
- Understanding the quantity of mAb fragments which must be removed and what can be dosed in small amounts
- Considering the conjugation technology and conditions used as well as their upscale applications
- Creating a platform to increase conjugation yield
2:45 pm Afternoon Networking Break
Anticipating Specific Strategies to Onboard Your Drug Product Development Decrease Costs & Improve Timelines
3:15 pm Safety Challenges and Hierarchy of Controls to Ensure Employee Wellbeing During ADC Production
Synopsis
- General ADC production outline
- Challenges we face in ADC production during clinical ADC production
- Hierarchy of controls we employ to deal with SAFETY and wellbeing of employees while managing production challenges, including: PPE & admin controls, engineering controls, substitutions & elimination of risks & opportunities in ADC production