Program at a Glance
Wednesday, November 12
3 PM
Registration
5 PM
Reception Dinner
Thursday, November 13
8 AM
Workshop Day 1
6 PM
Main Dinner
Friday, November 14
8 AM
Workshop Day 2
1 PM
Lunch
The agenda will be finalized a few weeks prior to the event.
Program Overview (Tentative)
Fundamentals and Regulatory
- New chapter in the European Pharmacopeia on high-throughput sequencing for the detection of viral extraneous agents
- Enhancing Viral Safety: Prior Knowledge and Platform Virus Clearance Strategies in the Era of ICH Q5A (R2)
- Implications of the ICHQ5A (R2) on viral clearance studies scopes
Nanofiltration of challenging plasma derived proteins
- Planova S20N evaluation on AT-III solution and its implementation
- Planova S20N evaluation on IVIG solution
- Visualization of virus trapping in the filter pore structure with protein solution
Rapid nanofiltration enabling highly efficient processing
- Evaluation of Planova FG1 Virus Filter: Enhancing Efficiency and Addressing Filterability Challenges in a Diverse Therapeutic Antibody Pipeline
- Planova FG1 and Planova S20N evaluations and comparison with different operating conditions
Cell Culture Clarification with Tangential Flow Microfiltration
- BioOptimal UMP evaluation and implementation in a perfusion cell culture process
- Evaluation of BioOptimal MF-SL in a cell culture producing AAV vectors
- Ensuring a proper design of your TFF setup to maximize performance
New Trends and Applications
- Media nanofiltration in the production of Advanced Therapy Medicinal Products (ATMP)
- Implementation of Planova 35N in a AAV vector production process to enhance viral safety
- Continuous nanofiltration with Planova S20N