AGENDA AT A GLANCE
8:00
Registration & Coffee
8:50
Chairman’s Welcome Address
The Future of Biologics Manufacturing
9:00
Commercial Manufacturability by Design: Why Scale-Up Success Starts During Development
- Integrating manufacturability into early development
- Bridging process development and commercial manufacturing
- Embedding QbD and process understanding from day one
- Avoiding costly scale-up and tech transfer failures
9:30
Reserved for Service Provider
10:30
Networking Break
Next-Generation Upstream Manufacturing
11:10
The Intensification Paradox: When More Upstream Productivity Creates Downstream Problems
- Are upstream teams optimising the wrong KPIs?
- When increased titres overwhelm downstream capacity
- Facility implications of intensified processes
- Balancing yield, quality and throughput
11:40
Reserved for Service Provider
12:10
AI-Driven Upstream Development: Can Digital Twins Predict Scale-Up Success?
- Current state of digital twin deployment
- Predictive cell culture modelling
- AI-assisted process development
- Separating hype from practical value
13:00
Lunch Break
Optimising Downstream Throughput
14:00
Maximising Yield Without Compromising Quality in Commercial Biologics Manufacturing
- Reducing product loss across the manufacturing process
- Balancing yield and product quality
- Process robustness at commercial scale
- Cost-of-goods optimisation
14:30
Reserved for Service Provider
15:00
From Process Understanding to Product Quality: Linking CPPs, CQAs and Downstream Performance
- Process understanding strategies
- Managing critical quality attributes
- Data-driven validation
- Regulatory expectations for commercial manufacturing
15:30
Networking Break
16:00
Roundtable Discussions
- Integrating AI into GMP Environments Without Compromising Compliance
- Bridging the Gap Between Process Development and Commercial Manufacturing (TBC)
- Biomanufacturing Without Silos: Connecting Development, Manufacturing, Quality and Supply Chain
- Building Supply Chain Resilience in an Era of Geopolitical Uncertainty
- Beyond the Contract: What Does a True Manufacturing Partnership Look Like?
17:00
Cocktail Reception
17:15
End of Day 1
8:50
Chairman’s Welcome Address
Advancing CMC for Next-Generation Biologics
9:00
Platform Processes Are Not Plug-and-Play: Adapting CMC Strategies for Complex Biologics
- When platform processes accelerate development
- When customisation becomes essential
- CMC considerations for ADCs and emerging modalities
- Balancing speed and flexibility
9:30
Reserved for Service Provider
10:00
Quality by Design in Practice: Strengthening Process Understanding for Commercial Scale-Up
- Building process understanding early
- Linking CPPs and CQAs
- Supporting comparability and validation
- Regulatory expectations for scale-up
10:30
Networking Break
Novel Approaches to Biosafety Testing
11:10
Building a Risk-Based Biosafety Testing Strategy for Complex
- Biologics Defining biosafety-testing requirements based on product modality, process risk, and development stage
- Integrating rapid and compendial methods without compromising data integrity or regulatory acceptability
- Establishing clear decision pathways for atypical results, investigations, and batch-impact assessment
- Aligning development, quality, manufacturing, and external testing partners around a coherent testing strategy
11:40
Reserved for Service Provider
12:10
From Cell Bank to Commercial Supply: Strengthening Contamination Control Across the Biologics Lifecycle
- Building viral-safety strategy into cell-bank qualification
- Identifying contamination risks across the manufacturing process
- Using monitoring and trend analysis to strengthen control
- Protecting supply continuity during investigations and scale-up
13:00
Lunch Break
AI, Digitalisation & Smart Biomanufacturing
14:00
Panel Discussion: AI in GMP Manufacturing: Where Is It Delivering Real Value Today?
- AI applications delivering measurable value across manufacturing and quality operations
- Balancing AI innovation with GMP compliance and data integrity
- Lessons learned from successful AI implementation in biomanufacturing
14:30
Reserved for Service Provider
15:00
Digital Twins for Bioprocess Development and Manufacturing: Are We There Yet?
- Current capabilities and limitations
- Process modelling and multivariate analysis
- Predicting scale-up performance
- Moving from equipment-level models to end-to-end process simulation
15:30
Networking Break
Building Flexible Facilities for a Multi-Modality Future
16:00
Single-Use vs Stainless Steel: What Will Define the Next Gen
- Drivers behind the shift toward single-use technologies
- When stainless steel still makes strategic sense
- Supporting flexible manufacturing models
- Implications for scale, cost, and operational efficiency
16:30
Designing Facilities for Process Intensification and Perfusion Manufacturing
- Facility implications of intensified processing
- Supporting perfusion at commercial scale
- Infrastructure requirements for higher productivity
- Balancing flexibility and capacity
17:00
Chairman’s Closing Remarks
17:15
END OF CONFERENCE
