AGENDA AT A GLANCE
8:00
Registration & Coffee
8:55
IMAPAC welcome address & Chairmans Welcome Address
Plenary Session
9:00
Biomanufacturing 4.0: How APAC & Europe Can Co-Develop Smart, Digitised Facilities
- Cross-Border Digital Twins: Creating mirrored facility models to allow European teams to troubleshoot Asian manufacturing lines in real-time.
- Standardising Automation: Harmonising equipment protocols (Plug-and-Play) between Eastern "Speed Engines" and Western "Quality Anchors."
- AI-Driven Deviation Management: Using predictive maintenance and AI to reduce unplanned downtime in high-volume facilities.
- Remote Factory Acceptance: Best practices for conducting virtual FATs (Factory Acceptance Tests) and audits across time zones.
9:25
Reserved for Solution Provider
Regulatory Outlook: MHRA & EMA Updates
- The "Control Site" Framework: Navigating the MHRA's new 2025 rules for Point-of-Care and decentralized manufacturing hubs.
- Annex 11 & GMP 4.0: Preparing for upcoming EMA revisions on computerised systems and AI in GMP environments.
- Inspection Readiness: Differences in GMP inspection priorities between the MHRA (post-Brexit divergence) and EU inspectorates.
- Managing Complex Supply Chains: Regulatory expectations for releasing batches where drug substance and drug product are made in different jurisdictions.
9:50
Innovation Panel: The Future of mAbs, ADCs & Outsourcing
- The "Make vs. Buy" Debate: Deciding when to build internal capacity for complex modalities (ADCs) vs. leveraging CDMOs.
- Retrofitting for Bispecifics: Engineering challenges when converting standard mAb facilities to handle multi-specific formats.
- Geopolitical Resilience: Strategies for "China + 1" sourcing and navigating the Biosecure Act’s impact on supply security.
- 2030 Capacity Forecast: Analyzing if current global stainless-steel capacity is sufficient for the coming wave of biosimilars and ADCs.
10:35
Networking Break
Antibody Engineering & Optimisation
11:00
Engineering Antibodies for Site-Specific Conjugation
- Moving beyond stochastic conjugation to precise DAR control
- Utilizing Cysteine-engineering and enzymatic technologies
- Improving homogeneity and therapeutic index
- Optimizing antibody stability for harsh conjugation conditions
11:25
Reserved for Solution Provider
11:50
The Next Frontier: Bispecific ADCs (bsADCs)
- Engineering dual-targeting formats for enhanced efficacy
- Overcoming chain-pairing and purification challenges
- Enhancing internalization rates through receptor cross-linking
- Navigating the manufacturing complexity of multi-specifics
12:35
Lunch & Poster Presentation
Advances in ADC Payload & Linker Chemistry Scalable ADC Manufacturing Workflows
14:00
Innovation in Linker-Payload Technologies
- Developing stable cleavable linkers to prevent systemic toxicity
- Moving beyond tubulin inhibitors to novel payloads (e.g., Topo I)
- Solving hydrophobicity issues to improve pharmacokinetics
- Strategies for diversifying payload supply chains (East-West integration)
14:25
Reserved for Solution Provider
14:50
Scaling Up Conjugation Processes for Commercialization
- Managing reaction kinetics and mixing at large scale
- Transitioning from multi-step to single-pot synthesis
- Effective removal of free payload and organic solvents
- Ensuring high-potency (HPAPI) containment during scale-up
15:15
Networking Break
16:00
Roundtable Discussions:
- Overcoming Bottlenecks in Commercial Biologics Scale-Up
- Improving Tech Transfer Between Sponsors & CDMOs
- Best Practices for High-Potency ADC Handling
- Workforce Skills Needed for the UK’s Biomanufacturing Future
- Cost Optimisation in Outsourced Manufacturing
16:45
Cocktail Reception & Award Ceremony
17:30
END OF DAY 1
8:00
Registration & Coffee
8:55
IMAPAC welcome address & Chairmans Welcome Address
Improving ADC Stability & Product Quality
9:00
Overcoming Aggregation and Formulation Challenges
- Managing hydrophobicity to prevent antibody aggregation
- Selecting optimal excipients for long-term stability
- Strategies for maximizing shelf-life of liquid formulations
- Minimizing impact of drug load (DAR) on stability
9:25
Reserved for Solution Provider
9:50
Advanced Analytics for Critical Quality Attributes (CQAs)
- Monitoring free payload and unconjugated antibody levels
- Ensuring consistent Drug-to-Antibody Ratio (DAR) distribution
- Implementing stability-indicating assays for complex molecules
- Detecting and characterizing process-related impurities
10:35
Networking Break
Process Intensification for ADCs / GMP Readiness for Manufacturing Operations
11:00
Intensifying the Conjugation and Purification Process
- Reducing reaction times and purification steps
- Strategies for continuous or single-pot conjugation
- Minimising solvent usage and waste generation
- Improving overall process yield and efficiency
11:25
Reserved for Solution Provider
11:50
Accelerating GMP Readiness for Commercial Scale-Up
- Streamlining tech transfer from pilot plants to commercial GMP suites
- Managing cleaning validation and cross-contamination in multi-product HPAPI facilities
- Establishing Critical Quality Attributes (CQAs) for commercial batch release
- Ensuring supply chain robustness for raw materials in large-scale campaigns ions for Phase I
12:35
Lunch & Poster Presentation
AI & Data Analytics for Process Robustness / Automation & Robotics in Biomanufacturing / Digitalisation of Outsourced Operations
14:00
The Digital Factory & The Virtual Handshake: Convergence of AI, Robotics, and Remote Oversight
- AI for Robustness: Utilizing predictive modeling to reduce process variability and prevent deviations.
- Robotics in Action: Implementing automated sterile filling and sampling to remove human error.
- Digital Outsourcing: establishing "virtual man-in-the-plant" capabilities via real-time data mirroring.
- Connected Ecosystems: Breaking silos between internal QMS and external CDMO data streams.
14:25
Reserved for Solution Provider
14:50
Case Study: Accelerating Tech Transfer via Digital Twins & In-Silico Modeling
- Simulating Scale-Up: Using Computational Fluid Dynamics (CFD) to predict risks before physical transfer.
- Virtual Experimentation: Reducing "wet lab" runs by validating parameters in-silico first.
- Multi-Site Consistency: establishing the Digital Twin as the "Single Source of Truth" for Asian and European sites.
- Deviation Management: AI analysis to identify root causes of batch variability 40% faster.
15:15
Networking Break
16:00
Closing Panel Discussion: Future of Biologics, Outsourcing & Next-Gen Antibody Modalities: What’s Next?”
- Where UK & EU biomanufacturing is heading
- How outsourcing models are evolving
- The future of complex modalities (ADCs, multispecifics, bioconjugates)
- Shared challenges across the supply chain
- Talent, capacity and technology needs
16:45
Joint Wrap-Up & Key Takeaways Session presented by: Biologics Manufacturing Chair, Bio-outsourcing Chair, Antibody and ADC Manufacturing Chair. Moderator shares all the learnings followed by Audience Q&A
