RXX Agenda

Saturday 1 June 2024
12:00 - 17:00	Early Registration Opens \| Abbot
17:00 - 19:00	Early Arrival Welcome Reception \| Abbot A chance to gather with the early arrival attendees! Stop by for a beverage to greet those peers who are already in town.
Sunday 2 June 2024
12:00 - 16:00	Registration \| Abbot
16:00 - 17:30	Cocktail Reception \| The Backyard Set against the backdrop of Sunriver’s breathtaking landscape, take the opportunity to kick-off RXX by connecting with colleagues new and old. We will gather for dinner while immersed in the natural beauty of Sunriver’s surroundings. The highlight of the dinner will be a special keynote, setting the tone for the days ahead. Dress comfortably and bring layers as temperatures drop in the evenings.
17:30 - 18:00	Opening Remarks \| The Backyard
19:00 - 20:00	Keynote \| The Backyard
20:30 - 22:30	Poster Session 1 \| Sage Springs Pavilion
Monday 3 June 2024
07:00 - 08:00	Welcome Breakfast \| Homestead
Oral Session 1: The Adventure Begins at Harvest \| Sage Springs Pavilion
Session Chairs:	Arick Brown, Amgen, United States Brandon Christensen, Visterra, United States
08:05 - 08:30	Single-use continuous centrifugation harvest for high density cell culture Oliver Kaltenbrunner, Amgen, United States
08:30 - 08:55	Efficient clarification strategies for high solid content cell culture fluids Haikuan Liu, WuXi Biologics, China
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 Daniel Hurwit, Bristol Myers Squibb, United States
09:20 - 09:45	A new multifaced player in the field of AAV harvest recovery and viral clearance Yulia Ivanova, Pfizer, United States
09:45 - 10:15	Mid-Morning Break \| Inside of Sage Springs Pavilion
Oral Session 2: Advances in Structure-Function Understanding and Developability Assessment for Novel Biologics \| Sage Springs Pavilion
Session Chairs:	Chen Wang, AbbVie, United States Peter Tessier, University of Michigan, United States
10:20 - 10:45	Developability Evaluation of Discovery Biologic Candidates by Screening Physicochemical and Accelerated Stability Properties Rajeeva Singh, AbbVie, United States
10:45 - 11:10	Evaluation of descriptors and machine learning strategies for monoclonal antibody chromatography process developability prediction Andrew Maier, Genentech, United States
11:10 - 11:35	Modeling the chromatography behavior of monoclonal antibodies in hydrophobic interaction chromatography Douglas Nolan, Takeda Pharmaceuticals, United States
11:35 - 12:00	Assessing the developability of fractionated monoclonal antibody proteoforms: Impact of charge, hydrophobicity, and glycans on aggregation susceptibility Solomon Isu, MilliporeSigma, United States
12:00 - 13:15	Lunch (Boxed) \| Sage Springs Pavilion
13:30 - 17:30	Networking Activities \| Offsite Participants will Meet at Besson Commons for Bus Pick Up
18:00 - 19:30	Dinner (Recovery Rodeo) \| Mt. Bachelor Lawn
20:30 - 22:30	Poster Session 2 \| Sage Springs Pavilion
Tuesday 4 June 2024
07:00 - 08:00	Breakfast \| Homestead
Oral Session 3: Mission Impurity Characterization: Advances, Challenges, and Regulatory Insights across Modalities \| Sage Springs Pavilion
Session Chairs:	Kristin Valente, Merck and Co., Inc., United States Andre Dumetz, GSK, United States
08:05 - 08:30	Quality By Design for Control of Polysorbate Degrading Host Cell Protein in Biologicals John Mattila, Regeneron Pharmaceuticals, United States
08:30 - 08:55	Tailoring Polishing Steps for Effective Removal of Polysorbate-Degrading Host Cell Proteins in Monoclonal Antibody Purification Melanie Maier, Boehringer Ingelheim, Germany
08:55 - 09:20	Progress and challenges towards characterization and control of impurities in antibody-drug conjugates Michaela Wendeler, AstraZeneca, United States
09:20 - 09:45	Advances in the Purification of Antisense Oligonucleotides Robert Gronke, Biogen, United States
09:45 - 10:15	Mid-Morning Break \| Homestead Landmark Abbot
10:15 - 12:00	Roundtables \| Roundtable #1: Abbot Roundtable #2: Homestead 1 Roundtable #3: Homestead 2 Roundtable #4: Homestead 3 Roundtable #5: Landmark 1. What do we do today to be ready for the next pandemic? Chairs: Sanchayita Ghose (BMS), Natraj Ram (Thermo Fisher Scientific), Brian Kelley (Vir Biotechnology) 2. Go big or go home – evolving bioprocessing for new modalities. Chairs: Alexei Voloshin (Solventum), Matthew Westoby (Resilience), Hans Johansson (Purolite) 3. What is the future of modeling for Recovery of Biological Products? Chairs: Mariona Bertran (Novo Nordisk)Karol Lacki (Repligen),David Roush (Roush Biopharma Panacea - RBP) 4. How can we drive down biopharma costs to $1 per dose for wider access? Chairs: Jorg Thommes (JT Consulting), Lisa Connell-Crowley (Just – Evotec Biologics), Suzanne Farid (UCL) 5. How do we implement sustainable production that is compatible with reduced costs? Chairs: Alois Jungbauer (BOKU), Kris Barnthouse (J&J), Jean Aucamp (Lonza)
12:00 - 13:15	Lunch \| Great Hall Complex
Oral Session 4: Escapades of a Continuous Nature \| Sage Springs Pavilion
Session Chairs:	Andrew Tustian, Regeneron Pharmaceuticals, United States Daniel Bracewell, University College London, United Kingdom
13:20 - 13:45	Integrated and continuous purification: the journey from hybrid to fully continuous, and from vision to reality Jason Walther, Sanofi, United States
13:45 - 14:10	Turning the crank using a hybrid continuous purification platform Michelle Najera, Just-Evotec Biologics, United States
14:10 - 14:35	Truly continuous purification platform – beyond the PoC Irina Ramos, AstraZeneca, United States
14:35 - 15:05	Afternoon Break \| Inside of Sage Springs Pavilion
Oral Session 5: Principles, Strategies and Highlights of Modelling and Data Analytics in Biomanufacturing \| Sage Springs Pavilion
Session Chairs:	Sophie Karkov, Novo Nordisk, Denmark Eric von Lieres, Research Center Jülich, Germany
15:10 - 15:35	Process development using an autonomous process optimizer Cornelia Walther, Boehringer-Ingelheim, Austria
15:35 - 16:00	Automated generation of digital twins and their use in real-time monitoring of process chromatography Daniel Espinoza, Lund University, Sweden
16:00 - 16:25	Universal Hybrid Chromatography Modeling Framework for Optimization of Multi-column Chromatography Systems Brandon Corbett, Sartorius, Canada
16:25 - 16:50	pH Transients and Elution Profiles in Protein A Affinity Chromatography: Experimental Observations, Modeling, and Approaches to Elution Buffer Engineering Rainer Hahn, BOKU, Austria, Giorgio Carta, University of Virginia, United States
16:50 - 17:15	Implementation of Mechanistic Model-Informed Chromatography Process Development and Validation: Successes and Challenges Connor Thompson, Genentech, United States
17:30 - 22:30	Offsite Evening Event \| Bend Brewing Company
Wednesday 5 June 2024
07:00 - 08:00	Breakfast \| Homestead
Oral Session 6: Adsorptive Separations Across the Universe of Biologics \| Sage Springs Pavilion
Session Chairs:	Stefano Menegatti, North Carolina State University, United States Kevin Brower, Sanofi, United States
08:05 - 08:30	Cleavable affinity tags can revolutionize biologics manufacturing – but how do we convince the FDA? David Wood, Ohio State University, United States
08:30 - 08:55	3D-printed matrices for the purification of plasmid DNA via steric exclusion chromatography Ana Rita Santos, iBB - Institute for Bioengineering and Biosciences, Portugal
08:55 - 09:20	Lentiviral Vector Determinants of Anion-Exchange Chromatography Elution Heterogeneity George Pamenter, University College London, United Kingdom
09:20 - 09:45	Overcoming challenges in the development of chromatographic separation of empty, partial, and full AAV capsids for Gene Therapy applications Vijesh Kumar, Spark Therapeutics, United States
09:45 - 10:15	Mid-Morning Break \| Inside of Sage Springs Pavilion
Oral Session 7: Separating without Sticking – Adventures in Non-Adsorptive Separations \| Sage Springs Pavilion
Session Chairs:	Elizabeth Goodrich, MilliporeSigma, United States Caryn Heldt, Michigan Tech, United States
10:20 - 10:45	Developing a Scale-Down Model for Batch Lysis in Plasmid DNA Purification Processes Ehsan Espah Borujeni, Bristol Myers Squibb, United States
10:45 - 11:10	Model-based optimization of Single Pass Tangential Flow Filtration (SPTFF) for concentration and purification of viral vectors Akshay Chaubal, Pennsylvania State University, United States
11:10 - 11:35	A unified view of virus and recombinant protein interactions with block copolymer membranes Daniele Gerion, Terapore Technologies, United States
11:35 - 12:00	Regulatory Considerations for Design and Implementation of Continuous Viral Inactivation Reactors Scott Lute, FDA/CDER/OPQ/OBP, United States
12:00 - 13:15	Lunch (Boxed) \| Sage Springs Pavilion
13:30 - 17:30	Networking Activities \| Offsite Participants will Meet at Besson Commons for Bus Pick Up
18:00 - 19:30	Dinner (Camp Recovery) \| Mt. Bachelor Lawn
19:30 - 20:30	Roundtable Readout \| Sage Springs Pavilion
20:30 - 22:30	Poster Session 3 \| Sage Springs Pavilion
Thursday 6 June 2024
07:00 - 08:00	Breakfast \| Homestead
Oral Session 8: Capers and Antics Across the Purification Process \| Sage Springs Pavilion
Session Chairs:	Yinying Tao, Eli Lilly and Company, United States Thomas von Hirschheydt, Roche, Germany
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 Julie Robinson, Merck and Co., Inc., United States
08:30 - 08:55	Process Intensification of Recombinant Adeno-Associated Viral Vector Production Andrew Tustian, Regeneron Pharmaceuticals, United States
08:55 - 09:20	The well-being approach for higher yields – how to make lentiviral vectors comfortable during downstream processing. Noor Mujahid, University College London , United Kingdom
09:20 - 09:45	Integrated continuous mRNA precipitation-based purification process Maria del Carme Pons Royo, MIT, United States
09:45 - 10:15	Mid-Morning Break \| Inside of Sage Springs Pavilion
Oral Session 9: Manufacturing Control and PAT: Successful Implementation and Continuing Obstacles \| Sage Springs Pavilion
Session Chairs:	Astrid Duerauer, BOKU & Austrian Centre of Industrial Biotechnology, Austria Emily Schirmer, Catalent Pharma Solutions, United States
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 Gang Wang, Boehringer Ingelheim, Germany
10:45 - 11:10	Right every time?! Assessing polishing chromatography under dynamic loading conditions Christopher McHardy, Roche , Germany
11:10 - 11:35	“Shaken not stirred”, why James Bond was right: the next generation PAT solution for downstream processing Karol Lacki, Repligen Corporation, Sweden
11:35 - 12:00	Case studies on combining spectroscopy and modern machine learning in DSP monitoring Robin Schiemer, Karlsruhe Institute of Technology, Germany
12:00 - 13:00	Lunch \| Homestead
Oral Session 10: Instagram vs. reality: Challenges, surprises, and successes in fitting your perfect process into an imperfect manufacturing facility \| Sage Springs Pavilion
Session Chairs:	Olga Paley, Takeda Pharmaceuticals, United States Brad Stanley, Biogen, United States
13:20 - 13:45	Achieving High-Titer and High-Concentration Monoclonal Antibody Production: an Innovative Journey Integrating with Next-Generation Bioprocessing Technologies Yinying Tao, Eli Lilly and Company, United States
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. Julian Hitzler, Novartis Pharma, Switzerland
14:10 - 14:35	The Balancing act in Biomanufacturing: Maximizing efficiency and flexibility when faced with an unpredictable product mix Evan Shave, Thermo Fisher Scientific, Australia
14:35 - 15:05	Afternoon Break \| Inside of Sage Springs Pavilion
Oral Session 11: Innovative Purification Technologies \| Sage Springs Pavilion
Session Chairs:	David Wood, Ohio State University, United States Brenda Carrillo-Conde, Pfizer, United States
15:10 - 15:35	Asymmetric bispecific antibody purification platforms using avidity effects of protein A and protein L affinity ligands Mats Ander, Cytiva, Sweden
15:35 - 16:00	Giving Novel Purpose to Protein A: A New Paradigm for Multispecific Antibody Manufacturing Arch Creasy, Pfizer, United States
16:00 - 16:25	Rational and combinatorial design of peptides for ss-mRNA/ds-mRNA separation and purification Pankaj Karande, Rensselaer Polytechnic Institute, United States
16:25 - 16:50	Innovative Protein Scaffolds for Single Step Purification from Proteins to Viral Vector Particles Romas Skudas, Merck Life Science KGaA, Germany
16:50 - 17:15	Closing Remarks \| Sage Springs Pavilion
18:00 - 22:30	Closing Dinner \| Great Hall
Friday 7 June 2024
07:00 - 08:00	Breakfast \| Homestead

RXX Sunriver, Oregon, June 2-7, 2024

RXX Agenda