AGENDA AT A GLANCE
8:30
Registration & Coffee
8:55
Chairman’s Welcome Note
Ireland’s Peptides & Oligonucleotides Industry: Innovation, Resilience and Digitalisation
9:00
Driving Innovation in Peptide & Oligonucleotide Manufacturing in Ireland
- Emerging technologies in synthesis, purification, and analytics
- Process intensification strategies for higher yield and efficiency
- Leveraging Ireland’s manufacturing ecosystem for collaborative R&D
- Case studies of recent innovations in oligo and peptide production
9:25
Reserved for Solution Provider
9:50
Panel: Leading the Future of Peptide and Oligonucleotide Manufacturing: Strategies for Resilience, Digital Transformation, and Innovation in Ireland
- Leadership perspectives on driving digital adoption across manufacturing and supply chains
- Strategic approaches to enhance operational resilience and risk mitigation
- Collaborations between industry, academia, and CDMOs to accelerate innovation
- Balancing regulatory compliance, process efficiency, and scalable manufacturing
10:15
Networking Break
Analytical Characterisation & Quality Control
11:00
Advanced Analytical Techniques for Peptide & Oligonucleotide Therapeutics
- Implementation of high-resolution methods such as LC-MS and HPLC for complex molecules
- Detecting and controlling impurities, modifications, and degradation products
- Optimising sample preparation and method sensitivity for challenging therapeutics
- Ensuring analytical comparability across clinical and commercial batches
11:25
Reserved for Service Provider
11:50
Integrating Real-Time Monitoring and Process Analytical Technology (PAT)
- Leveraging real-time monitoring for upstream and downstream processes
- Early detection of deviations to maintain consistent product quality
- Supporting automation and predictive analytics to optimise manufacturing performance
- Enabling real-time release testing to accelerate product availability
12:15
Lunch Break
Oligonucleotide & Peptide Manufacturing and Process Development
13:15
Scaling Oligonucleotide & Peptide Manufacturing from Lab to Commercial Production
- Upstream and downstream process optimisation for scale-up
- Maintaining quality and consistency across clinical and commercial batches
- Process integration and technology transfer best practices
- Case studies of successful clinical-to-commercial transitions
14:00
Reserved for Solution Provider
14:25
Innovations in Process Development for Complex Biologics
- Advanced bioreactor strategies and cell line optimisation
- Purification and analytical integration for robust process control
- Implementing digital tools and process monitoring for efficiency
- Balancing productivity, regulatory compliance, and cost-effectiveness
14:50
Networking Break
16:00
Roundtable Discussions
- How Cross-Industry Collaboration is Accelerating Innovation and Driving Growth in Peptide and Oligonucleotide Manufacturing
- Identifying Emerging Trends and Opportunities to Shape the Future of TIDES Manufacturing
- Enhancing Cross-Functional Collaboration Across Manufacturing Teams
- Driving Operational Excellence and Innovation Through Industry Collaboration
16:30
Key Takeaways
16:45
Drink Reception & End of Day 1
8:30
Registration & Coffee
8:55
Chairman’s Welcome Note
CMC, Regulatory & Quality-by-Design Strategy
9:00
Developing Robust CMC Strategies to Ensure Compliance, Quality, and Commercial Readiness
- Designing control strategies and managing critical quality attributes
- Meeting regulatory expectations for peptides, oligonucleotides, and conjugates
- Leveraging process analytics to support inspections and compliance
- Aligning development and manufacturing with commercial goals
9:25
Reserved for Solution Provider
9:50
Applying Quality-by-Design Principles to Optimise Manufacturing and Product Consistency
- Embedding QbD from early development to commercial scale
- Ensuring reproducibility and comparability across sites
- Preparing for regulatory inspections and approvals
- Cross-functional collaboration for continuous improvement
10:15
Networking Break
Supply Chain Resilience & Capacity Strategy
10:45
Designing Flexible and Robust Supply Chains to Support Growing Peptide and Oligonucleotide Manufacturing Needs
- Material sourcing strategies and supplier diversification
- Risk management and contingency planning
- Adapting supply chains to clinical and commercial demand
- Opportunities to improve efficiency and reduce bottlenecks
11:10
Reserved for Service Provider
11:35
Panel Discussion - Capacity Planning and Operational Excellence to Maximise Throughput and Reliability
- Aligning production planning with pipeline growth
- Resource and workforce allocation strategies
- Ensuring consistent quality across multiple sites
- Lessons from real-world capacity challenges and solutions
12:00
Lunch Break
Smart Aseptic Fill-Finish
13:00
Implementing Automation and Advanced Technologies to Achieve Efficient and Reliable Aseptic fill-finish Operations
- Integration of robotics and automated systems for consistent production
- Reducing contamination risk and human error in sterile processes
- Streamlining workflows to maximise throughput and flexibility
- Case studies demonstrating successful automation adoption
13:45
Enhancing Quality, Reliability, and Operational Performance Through Data-Driven Fill-Finish Strategies
- Real-time monitoring and predictive maintenance using PAT
- Integrating upstream and downstream processes for operational efficiency
- Maintaining sterility and regulatory compliance
- Operational lessons from commercial-scale implementation
14:10
Networking Break
14:40
Quality Control Strategies for Scalable Manufacturing
- Developing robust QC protocols across clinical and commercial scale production
- Ensuring compliance with global regulatory standards and inspection readiness
- Managing batch-to-batch variability using statistical process control
- Coordinating cross-functional teams (QC, manufacturing, and R&D) to maintain product integrity
Shaping the Future: Of Peptide & Oligonucleotide Manufacturing
15:05
Strategic Innovations Driving Peptide & Oligonucleotide Manufacturing in Ireland
- Emerging technologies shaping manufacturing workflows and process efficiencies
- Leveraging Ireland’s biopharma ecosystem for collaboration and innovation
- Optimising scale-up strategies from clinical to commercial production
- Integrating digitalisation and process analytics to improve throughput and quality
15:30
Emerging Opportunities and Future Trends in Biopharmaceutical Manufacturing
- Identifying growth areas in oligonucleotide and peptide therapeutics
- Opportunities for cross-functional collaboration and partnerships
- Implementing resilience strategies for supply chain, regulatory, and operational challenges
- Lessons learned from current manufacturing practices to inform future innovation
15:55
Chairman's Closing Remarks
16:00
END OF CONFERENCE
