RXX Agenda
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Sunday 2 June 2024 |
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12:00 - 16:00 |
Registration |
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16:00 - 17:30 |
Cocktail Reception |
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17:30 - 18:00 |
Opening Remarks |
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19:00 - 20:00 |
Keynote |
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20:30 - 22:30 |
Poster Session 1 |
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Monday 3 June 2024 |
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07:00 - 08:00 |
Welcome Breakfast |
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Session Chairs: |
Arick Brown, Horizon Therapeutics, United States |
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08:05 - 08:30 |
Single-use continuous centrifugation harvest for high density cell culture
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08:30 - 08:55 |
Efficient clarification strategies for high solid content cell culture fluids
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08:55 - 09:20 |
5-in-1 application of an off-the shelf charged fibrous device allows for hyper-intensified production of recombinant Adeno-Associated Viral vectors
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09:20 - 09:45 |
A new multifaced player in the field of AAV harvest recovery and viral clearance
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09:45 - 10:15 |
Mid-Morning Break |
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Session Chairs: |
Chen Wang, AbbVie, United States |
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10:20 - 10:45 |
Developability Evaluation of Discovery Biologic Candidates by Screening Physicochemical and Accelerated Stability Properties
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10:45 - 11:10 |
Evaluation of descriptors and machine learning strategies for monoclonal antibody chromatography process developability prediction
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11:10 - 11:35 |
Modeling the chromatography behavior of monoclonal antibodies in hydrophobic interaction chromatography
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11:35 - 12:00 |
Assessing the developability of fractionated monoclonal antibody proteoforms: Impact of charge, hydrophobicity, and glycans on aggregation susceptibility
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12:00 - 13:15 |
Lunch (Boxed) |
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13:30 - 17:30 |
Networking Activities |
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18:00 - 19:30 |
Dinner (Recovery Rodeo) |
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20:30 - 22:30 |
Poster Session 2 |
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Tuesday 4 June 2024 |
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07:00 - 08:00 |
Breakfast |
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Session Chairs: |
Kristin Valente, Merck and Co., Inc., United States |
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08:05 - 08:30 |
Quality By Design for Control of Polysorbate Degrading Host Cell Protein in Biologicals
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08:30 - 08:55 |
Tailoring Polishing Steps for Effective Removal of Polysorbate-Degrading Host Cell Proteins in Monoclonal Antibody Purification
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08:55 - 09:20 |
Progress and challenges towards characterization and control of impurities in antibody-drug conjugates
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09:20 - 09:45 |
Advances in the Purification of Antisense Oligonucleotides
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09:45 - 10:15 |
Mid-Morning Break |
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10:15 - 12:00 |
Workshops
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12:00 - 13:15 |
Lunch |
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Session Chairs: |
Andrew Tustian, Regeneron Pharmaceuticals, United States |
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13:20 - 13:45 |
Integrated and continuous purification: the journey from hybrid to fully continuous, and from vision to reality
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13:45 - 14:10 |
Turning the crank using a hybrid continuous purification platform
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14:10 - 14:35 |
Truly continuous purification platform – beyond the PoC
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14:35 - 15:05 |
Afternoon Break |
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Session Chairs: |
Sophie Karkov, Novo Nordisk, Denmark |
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15:10 - 15:35 |
Process development using an autonomous process optimizer
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15:35 - 16:00 |
Automated generation of digital twins and their use in real-time monitoring of process chromatography
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16:00 - 16:25 |
Universal Hybrid Chromatography Modeling Framework for Optimization of Multi-column Chromatography Systems
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16:25 - 16:50 |
pH Transients and Elution Profiles in Protein A Affinity Chromatography: Experimental Observations, Modeling, and Approaches to Elution Buffer Engineering
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16:50 - 17:15 |
Implementation of Mechanistic Model-Informed Chromatography Process Development and Validation: Successes and Challenges
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17:30 - 22:30 |
Offsite Evening Event |
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Wednesday 5 June 2024 |
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07:00 - 08:00 |
Breakfast |
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Session Chairs: |
Stefano Menegatti, NC State University, United States |
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08:05 - 08:30 |
Cleavable affinity tags can revolutionize biologics manufacturing – but how do we convince the FDA?
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08:30 - 08:55 |
3D-printed matrices for the purification of plasmid DNA via steric exclusion chromatography
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08:55 - 09:20 |
Lentiviral Vector Determinants of Anion-Exchange Chromatography Elution Heterogeneity
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09:20 - 09:45 |
Overcoming challenges in the development of chromatographic separation of empty, partial, and full AAV capsids for Gene Therapy applications
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09:45 - 10:15 |
Mid-Morning Break |
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Session Chairs: |
Elizabeth Goodrich, MilliporeSigma, United States |
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10:20 - 10:45 |
Developing a Scale-Down Model for Batch Lysis in Plasmid DNA Purification Processes
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10:45 - 11:10 |
Model-based optimization of Single Pass Tangential Flow Filtration (SPTFF) for concentration and purification of viral vectors
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11:10 - 11:35 |
A unified view of virus and recombinant protein interactions with block copolymer membranes
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11:35 - 12:00 |
Regulatory Considerations for Design and Implementation of Continuous Viral Inactivation Reactors
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12:00 - 13:15 |
Lunch (Boxed) |
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13:30 - 17:30 |
Networking Activities |
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18:00 - 19:30 |
Dinner (Camp Recovery) |
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19:30 - 20:30 |
Workshop Readout |
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20:30 - 22:30 |
Poster Session 3 |
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Thursday 6 June 2024 |
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07:00 - 08:00 |
Breakfast |
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Session Chairs: |
Yinying Tao, Eli Lilly and Company, United States |
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08:05 - 08:30 |
When the platform doesn’t fit: Simultaneous innovation of process and platform during downstream development of a challenging Fc-fusion protein
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08:30 - 08:55 |
Process Intensification of Recombinant Adeno-Associated Viral Vector Production
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08:55 - 09:20 |
The well-being approach for higher yields – how to make lentiviral vectors comfortable during downstream processing.
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09:20 - 09:45 |
Integrated continuous mRNA precipitation-based purification process
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09:45 - 10:15 |
Mid-Morning Break |
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Session Chairs: |
Astrid Duerauer, BOKU & Austrian Centre of Industrial Biotechnology, Austria |
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10:20 - 10:45 |
The minimum requirement on PAT’s success for industrial implementation:
The simultaneous prediction of multiple relevant Product Quality Attributes in real-time
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10:45 - 11:10 |
Right every time?! Assessing polishing chromatography under dynamic loading conditions
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11:10 - 11:35 |
“Shaken not stirred”, why James Bond was right: the next generation PAT solution for downstream processing
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11:35 - 12:00 |
Case studies on combining spectroscopy and modern machine learning in DSP monitoring
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12:00 - 13:00 |
Lunch |
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Session Chairs: |
Olga Paley, Takeda Pharmaceuticals, United States |
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13:20 - 13:45 |
Achieving High-Titer and High-Concentration Monoclonal Antibody Production: an Innovative Journey Integrating with Next-Generation Bioprocessing Technologies
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13:45 - 14:10 |
How far can we push the limits of connected biopharmaceutical manufacturing? – Unleashing the full potential of an intensified and connected purification process.
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14:10 - 14:35 |
The Balancing act in Biomanufacturing: Maximizing efficiency and flexibility when faced with an unpredictable product mix
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14:35 - 15:05 |
Afternoon Break |
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Session Chairs: |
David Wood, Ohio State University, United States |
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15:10 - 15:35 |
Asymmetric bispecific antibody purification platforms using avidity effects of protein A and protein L affinity ligands
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15:35 - 16:00 |
Giving Novel Purpose to Protein A: A New Paradigm for Multispecific Antibody Manufacturing
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16:00 - 16:25 |
Rational and combinatorial design of peptides for ss-mRNA/ds-mRNA separation and purification
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16:25 - 16:50 |
Innovative Protein Scaffolds for Single Step Purification from Proteins to Viral Vector Particles
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16:50 - 17:15 |
Closing Remarks |
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18:00 - 22:30 |
Closing Dinner |
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Friday 7 June 2024 |
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07:00 - 08:00 |
Breakfast |