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Pre-Con Workshop Day (27th April 2026) - CET/CEST (Cent Europe Summer, GMT+2)
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Pre-Con Workshop Day (27th April 2026) - CET/CEST (Cent Europe Summer, GMT+2)
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08:00 - 08:55
Registration
Showing 3 of 3 Streams
Workshop 1: CMC Roadmap
Workshop 2: Intensified & Continuous Processing
Workshop 3: Mastering Drug Product Formulation & Fill-Finish
08:55 - 09:00
Opening Remarks
09:00 - 10:30
CMC Roadmap
This full 1-day course will cover necessary considerations for developing new biologics in the CMC pathway.
- CMC Studies in the life cycle
- Requirements from Pre-Clinical to Phase 2 CT
- Case Study and Group Exercise
- Margit Holzer - Scientific Director, Ulysse Consult
- Thomas Chattaway - Senior Life Science Consultant, Independent
08:55 - 09:00
Opening Remarks
09:00 - 09:30
De-Bottlenecking Downstream Processing in an Era of High-Titre Harvests
- Harsha Reddy Borra - Group Leader – Biosimilar Development, Accord Healthcare Limited, UK
09:30 - 10:00
Using Process Models to Design a Balanced End-to-End Continuous Process
08:55 - 09:00
Opening Remarks
09:00 - 09:30
Practical Strategies for Developing and Manufacturing High-Concentration Formulations
09:30 - 10:00
Preventing Aggregation and Particle Formation with a Multi-Faceted Approach
10:00 - 10:30
Sponsored Session
Showing 1 of 1 Streams
Breaks & Networking
10:30 - 11:15
Morning Break
Showing 3 of 3 Streams
Workshop 1: CMC Roadmap
Workshop 2: Intensified & Continuous Processing
Workshop 3: Mastering Drug Product Formulation & Fill-Finish
11:15 - 12:15
CMC Roadmap
This full 1-day course will cover necessary considerations for developing new biologics in the CMC pathway.
CMC Studies in the life cycle
Requirements from Pre-Clinical to Phase 2 CT
Case Study and Group Exercise
- Margit Holzer - Scientific Director, Ulysse Consult
- Thomas Chattaway - Senior Life Science Consultant, Independent
11:15 - 11:45
Perfusion in Practice: A Deep Dive into Cell Retention Technologies and High-Density Culture
11:45 - 12:15
Intensifying Existing Fed-Batch Facilities with the Power of N-1
11:15 - 11:45
Implementing Automated, Gloveless Filling Lines for Flexibility and Sterility
11:45 - 12:15
Ready-to-Use (RTU) Components: Accelerating Timelines and De-risking the Supply Chain
Showing 1 of 1 Streams
Breaks & Networking
12:15 - 13:15
Lunch
Showing 3 of 3 Streams
Workshop 1: CMC Roadmap
Workshop 2: Intensified & Continuous Processing
Workshop 3: Mastering Drug Product Formulation & Fill-Finish
13:15 - 14:45
CMC Roadmap
This full 1-day course will cover necessary considerations for developing new biologics in the CMC pathway.
CMC Studies in the life cycle
Requirements from Pre-Clinical to Phase 2 CT
Case Study and Group Exercise
- Margit Holzer - Scientific Director, Ulysse Consult
- Thomas Chattaway - Senior Life Science Consultant, Independent
13:15 - 13:45
Continuous Revolution: Implementing Multi-Column and SMB Systems for Capture and Polish
13:45 - 14:15
Designing and Validating a Fully Connected Downstream Train
14:15 - 14:45
Sponsored Session
13:15 - 13:45
Overcoming Fill-Finish and Cryopreservation Hurdles for Cell Therapies
13:45 - 14:15
Implementing Advanced PAT for Lyophilization Cycle Optimization and Real-Time Control
14:15 - 14:45
Sponsored Session
Showing 1 of 1 Streams
Breaks & Networking
14:45 - 15:30
Afternoon Break
Showing 3 of 3 Streams
Workshop 1: CMC Roadmap
Workshop 2: Intensified & Continuous Processing
Workshop 3: Mastering Drug Product Formulation & Fill-Finish
15:30 - 16:30
CMC Roadmap
This full 1-day course will cover necessary considerations for developing new biologics in the CMC pathway.
CMC Studies in the life cycle
Requirements from Pre-Clinical to Phase 2 CT
Case Study and Group Exercise
- Margit Holzer - Scientific Director, Ulysse Consult
- Thomas Chattaway - Senior Life Science Consultant, Independent
15:30 - 16:30
PANEL DISCUSSION: The Integrated Future - Connecting Process, Data, and People in the Smart Factory
15:30 - 16:30
PANEL DISCUSSION: The Final Hurdle - An Integrated View on Drug Product Commercialization
16:30 - 16:35
End of Pre-Conference Day
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