8:00 am Check In & Morning Coffee
9:00 am Chair’s Opening Remarks
Optimizing Purification Strategies to Tackle Impurities & Streamline Unit Operations
9:15 am Chemistry & Analysis of Process Related Variants, Impurities & Degradation Products
Synopsis
- Exploring Host Cell proteins (HCPs), particularly enzymes that may cleave the linkers
- Discovering and elucidating unknown species and novel chemistry, such as photodegradation and crosslinking
- Outlining biotransformation vs. formulation: in vivo stability vs. in vitro stability
9:45 am Roundtable Discussion: Reducing Chromatography Dependence Through Smarter Upstream Control
Synopsis
- Hear how optimized reaction parameters, buffer systems, and TFF design can reduce or eliminate chromatography steps
- See case examples where simpler ADCs are purified without added unit operations
- Evaluate when chromatography remains essential for complex formats and DARspecific separation
10:15 am Morning Break & Speed Networking
Synopsis
Use this session to connect with like-minded peers working within the ADC process development space and have important conversations that could help you overcome shared challenges.
Aligning Process Development With Regulatory CMC Expertise for Building Compliant Strategies
11:15 am Session Reserved for BSP Pharmaceuticals
11:30 am Balancing Early Development Flexibility With Regulatory Expectations for ADC Process Development
Synopsis
- Understanding what must be locked down before pivotal trials and BLA submissions
- Exploring what is considered acceptable early-phase deferrals and how to justify them
- Understanding what the “must-do” aspects of process development are and what can be deferred for IND approval, in order to improve costs and speed of early development
12:00 pm Networking Lunch
Optimizing ADC Process Development for Scalable, Phase-Appropriate Manufacturing & Regulatory Success
1:00 pm Roundtable Discussion: Defining CQA-Driven Specifications to Guide Scalable & Phase-Appropriate ADC Process Development
Synopsis
- Identifying how setting realistic, phase-appropriate specifications can streamline scale-up
- Exploring how factors such as conjugation heterogeneity and stability impact specification limits at larger scale
- Discussing what can be deferred vs. what must be locked down from early phase onward
1:30 pm Development & Manufacturing Strategies for an ADC With Novel Payload for Clinical Evaluation
Synopsis
- Introduction of a new ADC class with steroid payload
- Discussing unique development and manufacturing challenges for ADC with steroid payload
- Reviewing a case study in PD, quality, stability, in vitro and in vivo efficacy, among others
2:00 pm Afternoon Break & Scientific Poster Presentation
Synopsis
This is an informal part of the conference agenda, allowing you to connect with your process development peers in a relaxed atmosphere and present your research to the ADC community.
Preparing & Executing Technology Transfer for Minimal Cost & Delays
3:00 pm Roundtable Discussion: Discussing Single-Use vs. Stainless Steel in Conjugation, Purification & Scale Up
Synopsis
- Comparing the operational, safety, and regulatory pros and cons of single-use vs. stainless steel systems in conjugation and purification steps
- Hearing how different CDMO practices, solvent handling needs, and facility flexibility requirements can play into equipment choices during scale-up
- Sharing case studies of the advantages and limitations of each approach
4:00 pm ADC DS Tech Transfer: Challenges & Best Practices
Synopsis
- Exploring challenges encountered across multiple scales
- Establishing extraordinary business processes
- Discussing learning curves and best practices for ADC manufacturing