AGENDA AT A GLANCE
8:00
Registration & Welcome Coffee
8:55
IMAPAC & Chairman's Welcome Address
Manufacturing Excellence in a High-Cost Environment
9:00
Achieving Operational Excellence through Digital Integration and Strategic Investment
9:25
Strategic Integration of Innovative Technologies - Balancing Client Expectations with Platform Efficiency
9:50
Reserved for Solution Provider
10:15
From Batch to Continuous: When continuous manufacturing makes economic sense in high-cost market
10:40
Networking Break
Next-Gen Upstream Processing: Intensification & Perfusion
11:15
Maximising Cost Efficiency through Process Redesign and Technical Optimisation
- Decision frameworks for transitioning from traditional batch to intensified manufacturing.
- Real world implementation data and performance figures for cost reduction.
- Regulatory filing strategies and CMC documentation for process modifications.
- Resource optimisation models for reducing overheads in commercial scale production.
11:40
Reserved for Solution Provider
12:05
Accelerating the Strategic Transition to Large-Scale Biologics Production
- Clinical supply manufacturing frameworks for operating in high-cost locations.
- Technical transfer partnerships and the role of UK sites in global networks.
- Workforce transformation strategies for the effective adoption of next gen modalities.
- Operational models for ensuring site agility during the transition in manufacturing focus.
12:30
Lunch & Poster Presentation
Downstream Purification Optimisation
14:00
Achieving Substantial Cost Savings through Downstream Process Optimisation
- Protein A resin lifetime extension strategies for lowering raw material expenditure.
- Business cases for continuous chromatography to enhance purification throughput.
- Buffer management optimisation for streamlining large scale manufacturing logistics.
- Process intensification techniques for reducing the total operational footprint.
14:25
Reserved for Solution Provider
14:50
Ensuring Regulatory Alignment through Proactive Quality and Compliance Strategies
- Implementation of the new 4 log standard for enhanced viral safety and assurance.
- Risk based methodologies for viral clearance studies to streamline process validation.
- Analysis of MHRA and EMA inspection trends from 2024 to 2026 for audit readiness.
- Proactive compliance models for anticipating future shifts in global regulatory expectations.
15:20
Networking Break
15:50
Interactive Roundtable Sessions:
- Regulatory Round table: Navigating Global Compliance Standards and Evolving Expectations for Next Generation Manufacturing.
- Operational Excellence Round table: Implementing Strategies for Process Robustness and the Reduction of Manufacturing Deviations.
- Technology Integration Round table: Evaluating the Business Case and Technical Hurdles for Adopting Digital and Automated Solutions.
- Supply Chain Round table: Strengthening Resource Resilience and Strategic Partnerships for Critical Material Procurement.
- External Manufacturing Round table: Optimising CDMO Partnerships and Technical Transfer Protocols for Global Production Networks.
- Workforce Development Round table: Bridging the Skills Gap and Preparing Teams for Future Biomanufacturing Modalities.
16:50
Cocktail Reception & Award Ceremony
18:00
END OF DAY 1
8:50
IMAPAC & Chairman's Welcome Address
AI & Data Analytics for Process Robustness
9:00
OPENING PANEL
Transitioning From Pilot to Production Through AI and Digital Manufacturing Integra
- Evaluating the practical application of digital solutions within GMP environments versus early-stage proof of concept models.
- Analysing measurable outcomes and operational efficiencies derived from the GSK Q Block smart manufacturing investment.
- Navigating regulatory validation requirements from the FDA, EMA, and MHRA for digital and AI driven process controls.
- Scaling digital architectures across global networks to ensure long term consistency and manufacturing excellence.
9:50
Reserved for Solution Provider
10:15
Driving Digital Transformation at Scale through Global Electronic Batch Record Implementation
- Developing the business case by comparing expected returns against actual realised value after two years of operation.
- Implementing change management strategies to ensure seamless adoption by shop floor operators and quality assurance teams.
- Monitoring performance metrics to quantify reductions in manufacturing deviations and improvements in batch release timelines.
- Scaling digital systems across multiple global sites to maintain process consistency and operational transparency.
10:40
Networking Break
Building Future-Ready Biomanufacturing Capacity
11:10
Optimising Strategic Network Design through Make vs Buy Decision Frameworks
- Developing robust make vs buy decision frameworks to align internal manufacturing capabilities with global supply requirements.
- Implementing comprehensive CDMO performance metrics to ensure quality and technical reliability across externalised networks.
- Executing dual sourcing strategies to mitigate supply chain risk without doubling operational or capital costs.
- Aligning network strategy with long term product lifecycle demands to maintain manufacturing agility and cost efficiency.
11:35
Reserved for Solution Provider
12:00
Optimising Decentralised Manufacturing Frameworks for Innovative Therapeutic Delivery
- The July 2025 regulatory landscape and its enabling effects on point of care and modular manufacturing for ATMPs.
- Hub and spoke models for supervising distributed production sites through a single central control site.
- Quality oversight protocols for maintaining consistency and compliance across non traditional manufacturing locations.
- Risk mitigation strategies for ensuring product traceability and safety within decentralised supply networks.
12:30
Lunch & Poster Presentation
Manufacturing Readiness for the Next 5 Years
14:00
Evaluating the Business Case and Long-Term Viability of Continuous Manufacturing
- Economic frameworks for identifying cost saving thresholds and a 40 to 50 percent reduction in unit costs compared to batch processing.
- Integration of the ICH Q13 guidelines to navigate regulatory conservatism and enhance technical validation for GMP implementation.
- Scaling strategies for transitioning from hybrid models to end to end continuous workflows to improve facility footprint and sustainability.
- Prediction of market maturation from 2026 to 2030 and the transition of continuous methods into mainstream commercial production.
14:25
Reserved for Solution Provider
14:50
OPENING PANEL
Optimising External Networks through Strategic Make vs Buy Decision Models
- Developing innovative capital sharing and performance-based contracts to align CDMO incentives with product success.
- Implementing geographic diversification strategies to mitigate geopolitical risks and ensure supply chain continuity across global regions.
- Executing rigorous due diligence and technical assessments to prevent technology transfer failures and maintain regulatory credibility.
- Integrating digital transparency tools for real time visibility into external manufacturing performance and operational outcomes.
15:30
Networking Break
Supply Chain and Logistics
16:00
CLOSING KEYNOTE
Building Resilient Supply Chains for Next-Generation Biologics Manufacturing
- AI-Driven Sourcing: Deploying decision intelligence to predict and mitigate single-supplier risks for resins and single-use systems.
- Predictive Cold Chain: Using end-to-end control tower data for real-time excursion prevention and automated 2-8°C compliance.
- Logistical Friction Analytics: Data-driven Brexit impact modelling to optimise cross-border routes and minimise lead-time delays.
- Scaling Decision Velocity: Transitioning digital pilots into global architectures to drive shop-floor process robustness and operational excellence.
16:30
CLOSING PANEL
Securing Supply Chain Resilience While Managing Costs in European Biologics Manufacturing
- Strategic Diversification: Implementing geographic dual-sourcing and validated second-sources to ensure material continuity without doubling capital expenditure.
- Performance-Based Partnerships: Utilising risk-sharing models and integrated review cycles to align vendor incentives with manufacturing reliability and quality.
- Cross-Border Logistics: Navigating post-Brexit customs protocols and import testing to maintain lead-time consistency across UK-EU networks.
- Digital End-to-End Visibility: Leveraging decision intelligence and real-time tracking to eliminate logistics bottlenecks and monitor inventory levels.
