AGENDA AT A GLANCE
8:00
Registration & Coffee
8:50
Chairman’s Welcome Address
Current State of Oligo & Peptides Manufacturing in DACH Region
9:00
Advancements and Trends in Oligonucleotide & Peptide Manufacturing in the DACH Region
- Current landscape and capabilities of oligo and peptide manufacturing in Germany, Austria, and Switzerland
- Emerging technologies improving yield, efficiency, and scalability
- Collaborative initiatives between industry, CDMOs, and academic research centres
- Lessons learned from recent manufacturing scale-ups and commercialisation efforts
9:30
Reserved for Service Provider
10:00
Panel Discussion: Overcoming Operational and Regulatory Challenges in the DACH Region
- Navigating regional regulatory expectations for complex oligos and peptides
- Strategies to address supply chain risks and raw material availability
- Integration of digital tools and analytics for process control and quality assurance
- Best practices for cross-site technology transfer and operational excellence
10:30
Networking Break
Analytical Characterization & Quality Control
11:10
Advanced Analytics for TIDES Molecules
- LC-MS methods for complex peptides and oligonucleotides
- Impurity profiling and identification of critical quality attributes
- Stability-indicating methods to monitor degradation pathways
- Reference standards & method validation
11:40
Reserved for Service Provider
12:10
Digitalisation and Automation in QC Labs
- Integrating automated platforms for high-throughput analysis
- Real-time release testing: opportunities and limitations
- Predictive analytics and AI for process and product quality monitoring
- Data integrity, regulatory compliance, and digital record-keeping
13:00
Lunch Break
Formulation and Delivery Strategies
14:00
Advanced Formulation Strategies for Stability, Efficacy and Developability of Biologics and Complex Modalities
- Designing robust formulations to improve stability and shelf-life of biologics and advanced therapies
- Managing aggregation, viscosity, and degradation challenges in high-concentration formulations
- Selecting optimal excipients and buffer systems for antibodies, ADCs, and novel modalities
- Integrating developability assessments early to reduce downstream formulation risks
14:30
Reserved for Service Provider
15:00
Innovative Drug Delivery Approaches for Next-Generation Biologics and Targeted Therapies
- Advancing delivery technologies for improved tissue targeting and therapeutic efficiency
- Overcoming biological barriers to enhance bioavailability and intracellular delivery
- Evaluating delivery systems such as nanoparticles, LNPs, and sustained-release platforms
- Aligning formulation design with clinical performance and patient-centric delivery requirements
15:30
Networking Break
16:00
Roundtable Discussions
- AI-Powered Drug Discovery & Digital Innovation
- Next-Generation TIDES Modalities & Therapeutic Innovation
- Advanced Delivery Technologies & Targeted Therapeutic Systems
- Partnering for Success: The Future of Pharma-Biotech Collaboration in TIDES
17:00
Cocktail Reception
17:15
End of Day 1
8:50
Chairman’s Welcome Address
Process Development & Scale-Up
9:00
Best Practices for Technology Transfer and Ensuring GMP Readiness in Late-Stage Development
- Best practices for site-to-site technology transfer
- Ensuring compliance during late-stage scale-up and commercial production
- Risk management and process control for consistent product quality
- Cost-of-goods optimisation and resource planning for large-scale production
9:30
Reserved for Service Provider
10:00
Process Optimisation and Continuous Improvement for Complex Peptides and Oligonucleotides
- Process intensification strategies for complex peptides and oligonucleotides
- Implementing digital tools and automation to enhance process control
- Reducing variability and improving reproducibility across batches
- Lessons learned from troubleshooting scale-up challenges
10:30
Networking Break
Scaling Oligo & Peptide Manufacturing
11:10
Process Scale-Up Strategies for Efficient and Reproducible Oligonucleotide and Peptide Manufacturing
- Transitioning from lab-scale synthesis to GMP and commercial-scale manufacturing
- Managing scale-dependent challenges in solid-phase synthesis and purification
- Ensuring process robustness, reproducibility and batch-to-batch consistency
- Establishing scalable manufacturing platforms for clinical and commercial supply
11:40
Reserved for Service Provider
12:10
Overcoming Manufacturing and Quality Challenges in Large-Scale Oligo and Peptide Production
- Addressing impurity control and purification challenges during scale-up
- Optimising yield, cycle time and cost of goods (COGS) in large-scale production
- Ensuring analytical consistency and quality control across manufacturing scales
- Strengthening tech transfer and CDMO collaboration for seamless industrialisation
13:00
Lunch Break
Supply Chain and Outsourcing Strategies
14:00
Panel Discussion: Building Resilient and Agile Supply Chains for Biologics, Oligos and Peptides
- Strengthening end-to-end supply chain resilience in a volatile global environment
- Managing cold chain, logistics and distribution risks for complex modalities
- Improving visibility and digitalisation across global supply networks
- Aligning supply chain strategy with clinical, scale-up and commercial demand
14:30
Reserved for Service Provider
15:00
Strategic Outsourcing Models and CDMO Partnerships for Efficient Manufacturing
- Selecting the right CDMO partners across development and commercial stages
- Balancing in-house capabilities vs outsourcing for cost, speed and flexibility
- Strengthening governance, quality oversight and performance management of CDMOs
- Optimising tech transfer and collaboration models for seamless external manufacturing
15:30
Networking Break
CMC Strategy and Fill-Finish for Oligos & Peptides
16:00
Integrated CMC Strategies for Efficient Development of Oligonucleotide and Peptide Therapeutics
- Designing end-to-end CMC strategies from early development to commercial manufacturing
- Managing complexity in synthesis, purification and analytical control for oligos and peptides
- Aligning process development with regulatory expectations and quality requirements
- Enabling scalable and robust manufacturing platforms for clinical and commercial success
16:30
Advancing Fill-Finish Operations for Oligonucleotides and Peptides: Ensuring Quality and Scalability
- Overcoming fill-finish challenges for low-dose, high-potency oligonucleotide and peptide drugs
- Ensuring product stability and integrity during formulation, filling and packaging
- Selecting appropriate primary packaging systems for different delivery formats
- Scaling aseptic fill-finish processes from clinical to commercial production
17:00
Chairman’s Closing Remarks
17:15
END OF CONFERENCE
