RXIX - Daily Technical Program Schedule

Sunday 10 July 2022

14:00 - 16:00

Conference Check-In | Congress Foyer (-1)

16:00 -16:15
Conference Chairs

Welcome by RXIX Conference Chairs | Salone dei Cavalieri (-1)
Suzanne Farid, University College London (UCL), United Kingdom
Nihal Tugcu, Sanofi, United States
Arne Staby, Novo Nordisk, Denmark


Oral Session 1: Respice, Adspice, Prospice – Past, Present & Future Case Studies | Salone dei Cavalieri (-1)

Session Chairs:

Jennifer Pollard, Merck and Co., Inc., United States
Todd Przybycien, Rensselaer Polytechnic Institute, United States

16:15 - 16:20

Introduction by Session Chairs

16:20 - 16:45

What’s old is new – Continuous countercurrent staging for chromatographic separations and precipitation
Andrew Zydney, Penn State University, United States

16:45 - 17:10

Life-cycle Management and Process Enhancements for Over a Quarter-Century of Vaccine Supply
Kristin Valente, Merck and Co., Inc., United States

17:10 - 17:35

Veni, Vidi, Exemplavi - The past, present and future of industrial chromatography modeling
Felix Wittkopp, Roche Diagnostics GmbH, Germany

17:35 - 18:00

Purification Platform of the Future for Diverse Pipelines and Next Generation Manufacturing
Benoit Mothes, Sanofi, France

18:00 - 19:30

Welcome Reception | Tiepolo Terrace (0)

19:30 - 21:00

RXIX Opening Banquet | Salone dei Cavalieri (-1)


After Dinner Keynote | Salone dei Cavalieri (-1)

Host

Suzanne Farid, University College London (UCL), United Kingdom

21:00 - 21:45

The Anatomy of Hope
Kevin Fong, University College London Hospitals (UCLH), United Kingdom

21:45 - 23:00

RXIX Rooftop Social Hour | Terrazza degli Aranci (9)

Monday 11 July 2022

07:00 - 09:00

Breakfast | Le Bella Arti (-1)


Oral Session 2: A Call to Arms: Biotechnology’s Approach to Address Pandemics | Salone dei Cavalieri (-1)

Session Chairs:

Anne Kantardjieff, bluebird bio, United States
John Moscariello, Bristol Myers Squibb, United States

09:00 - 09:05

Introduction by Session Chairs

09:05 - 09:30

mRNA as a Platform for On-Demand Therapeutics and Pandemic Vaccines
Christopher Ladd Effio, Moderna, United States

09:30 - 09:55

Accelerated Development of Bamlanivimab
Richard Chen, Eli Lilly and Company, United States

09:55 - 10:20

Accelerated Development of Neutralizing Antibodies Targeting SARS-CoV-2
Christopher Cowan, Regeneron Pharmaceuticals, United States

10:20 - 10:45

Meeting the challenges of COVID-19 from a CDMO perspective
James Miskin, Oxford Biomedica, United Kingdom

10:45 - 11:15

Morning Break | Garden Lobby (-1)


Oral Session 3: Purification of Biologics with Chemical Synthesis Steps | Salone dei Cavalieri (-1)

Session Chairs:

Michaela Wendeler, AstraZeneca, United States
Thanmaya Peram, Genentech, United States

11:15 - 11:20

Introduction by Session Chairs

11:20 - 11:45

Assessment of Impurity & Product Variant Removal Methods for ADCs Conjugated with Novel Payloads
Xin Xin Lin, Genentech, United States

11:45 - 12:10

Oligonucleotide purification strategies and application of process modeling to define control strategy
Pranay Ghosh, Roche, Switzerland, Michelle Butler, Roche, Switzerland

12:10 - 12:35

mRNA-based therapeutics and vaccines - COVID-19 and beyond
Andreas Kuhn, BioNTech SE, Germany

12:35 - 13:30

Lunch (Boxed) I Garden Lobby (-1)

13:30 - 18:30

Afternoon Networking Activities (Optional) | Meeting Point: Congress Foyer (-1)

18:45 - 19:15

Cocktail Reception | Tiepolo Terrace (0)

19:15 - 20:30

Dinner I Tiepolo Terrace (0)


Poster Snapshot Session & Poster Session | Salone dei Cavalieri (-1)

Session Chairs:

Ana Azevedo, Instituto Superior Tecnico (IST), Portugal
Glen Bolton, Amgen, United States
Marco Rito-Palomares, Tecnologico de Monterrey, Mexico

20:30 - 21:00

Poster Snapshot Session 1
#2. General approaches and considerations for purification of hydrodynamically large Fab conjugates
Eileen Duenas, Genentech,United States
#7. Machine learning and advanced data analytics to better exploit process analytical technology for chromatography operation
Stephen Goldrick, University College London (UCL), United Kingdom
#9. Implementation of novel affinity ligand for Lentiviral vector purification
Ana Sofia Moreira, Instituto de Biologia Experimental e Tecnológica (iBET), Portugal
#12. Production of complex recombinant proteins in plant-based systems – From case studies in process development to regulatory approval
Johannes Buyel, Fraunhofer IME/RWTH Aachen University, Germany
#21. Downstream Bioprocess Challenges of a Novel Class of Nanobodies; Understanding Protein A Capture Step Aggregation Removal, Aggregation Formation and Formulation Utilizing Biophysical Analysis and Computational Modeling
Sandra Rios, Merck and Co., Inc., United States
#27. Evaluation of Ecofriendly Alternatives for a Virus Inactivation Detergent used in Biologics Manufacturing Process
Dong Yang, Bristol Myers Squibb, United States

21:00 - 23:00

Poster Session 1 with Desserts and Drinks

Tuesday 12 July 2022

07:00 - 09:00

Breakfast | Le Bella Arti (-1)


Oral Session 4: Separation Sciences in Advancing Novel Gene and Cell Therapies | Salone dei Cavalieri (-1)

Session Chairs:

Nooshafarin (Nooshie) Sanaie, Poseida Therapeutics, United States
Andrew Ramelmeier, Sangamo Therapeutics, United States

09:00 - 09:05

Introduction by Session Chairs

09:05 - 09:30

From blood to drug product, the isolation and purification of Treg cells
Pierre Heimendinger, Sangamo Therapeutics, France

09:30 - 09:55

Towards continuous processes for advanced therapy medicinal products
Manuel Carrondo, iBET, Portugal

09:55 - 10:20

Implications of AAV affinity column reuse and processing conditions on product quality attributes
Harshal Soni, Rensselaer Polytechnic Institute, United States

10:20 - 10:45

Removal of Empty AAV Capsids to Undetectable Levels Using Orthogonal Purification Steps – Product Quality and Process Robustness Considerations
Rahul Sheth, BioMarin Pharmaceutical Inc., United States

10:45 - 11:15

Morning Break | Garden Lobby (-1)


Oral Session 5: Modeling Next Generation Supply Chains & Facilities: Envisaging the Challenges – Engineering the Solutions | Salone dei Cavalieri (-1)

Session Chairs:

Jan Griesbach, Roche, Germany
Nigel Titchener-Hooker, University College London (UCL), United Kingdom

11:15 - 11:20

Introduction by Session Chairs

11:20 - 11:45

Next Generation Bioprocessing – Manufacturing and Facility Concepts
Rob OKeeffe, Eli Lilly / University College Dublin, Ireland

11:45 - 12:10

What do all CGT supply chains have in common? Designing for platform capabilities that bring down CoG and increase the chance of successful commercialization
Sebastian Schneider, Roche, Switzerland

12:10 - 12:35

Decisional tools for successful commercialisation of cell and gene therapies: industrial case studies
Christos Stamatis, University College London (UCL), United Kingdom

12:35 - 13:45

Lunch Buffet | Le Bella Arti (-1) & Garden Lobby (-1)


Keynote | Salone dei Cavalieri (-1)

Host

Arne Staby, Novo Nordisk A/S, Denmark

13:45 - 14:30

Precision Medicine for Cancer Treatment Leveraging Industrialized, Robust and Simple Bispecific Antibody Platform: Learnings from a 10-year Journey
Hanne Bak, Regeneron Pharmaceuticals, United States

14:30 - 14:45

Stretch Break


Oral Session 6: All Roads Lead to Rome – But Which Roads Lead to Accelerated Bioprocess Development? | Salone dei Cavalieri (-1)

Session Chairs:

Sophie Karkov, Novo Nordisk, Denmark
Giorgio Carta, University of Virginia, United States

14:45 - 14:50

Introduction by Session Chairs

14:50 - 15:15

Scaling Down in HTPD
Marcel Ottens, Delft University of Technology, Netherlands

15:15 - 15:40

Predictive Models for Process Development and Multidimensional Real Time Monitoring in Downstream Processing
Astrid Duerauer, BOKU & Austrian Centre of Industrial Biotechnology, Austria

15:40 - 16:05

Evolving trends in monoclonal antibody production processes: From ‘platforms’ to ‘pandemic pace’ development
Sanchayita Ghose, Bristol Myers Squibb, United States

16:05 - 16:30

Rapid downstream process development for a SARS-CoV-2 vaccine candidate through High Throughput Process Development
Spyridon Konstantinidis, Merck and Co., Inc., United States

17:00 - 20:00

Vatican Tour | Meeting Point: Congress Foyer (-1)

20:00 - 23:00

Dinner (Offsite)

Wednesday 13 July 2022

07:00 - 09:00

Breakfast | Le Bella Arti (-1)

08:30 - 13:30

Morning Networking Activities (Optional) | Meeting Point: Congress Foyer (-1)

13:00 - 14:00

Lunch (Boxed) & Refresh | Garden Lobby (-1)


Keynote | Salone dei Cavalieri (-1)

Host

Arne Staby, Novo Nordisk A/S, Denmark

14:00 - 14:45

A Look Back in Order to Look Forward; Analysis of Historical Recovery Progress to Guide Future Innovations in the Biopharmaceutical Industry
Jill Myers, TG Therapeutics, United States


Oral Session 7: Manufacturability Assessment for Complex Biologics & Gene Therapies | Salone dei Cavalieri (-1)

Session Chairs:

Hong Li, Merck and Co., Inc., United States
Juergen Hubbuch, Karlsruhe Institute of Technology, Germany

14:45 - 14:50

Introduction by Session Chairs

14:50 - 15:15

Harnessing AAV Technology and Manufacturing Capabilities to Meet the Needs of the Gene Therapy Market
John Pieracci, Biogen, United States

15:15 - 15:40

Challenges During Recovery and Purification of AAV Gene Therapy
Michael Winkler, Regenxbio, United States

15:40 - 16:05

Predicting antibody developability
Peter Tessier, University of Michigan, United States

16:05 - 16:35

Afternoon Break | Garden Lobby (-1)


Oral Session 8: Big Data Analytics and Modeling in Biomanufacturing | Salone dei Cavalieri (-1)

Session Chairs:

Steven Cramer, Rensselaer Polytechnic Institute , United States
Joey Studts, Boehringer Ingelheim, Germany

16:35 - 16:40

Introduction by Session Chairs

16:40 - 17:05

Digital twins for MCSGP: accelerated model development and systematic design
Lisa Vetter-Joss, Novo Nordisk, Denmark

17:05 - 17:30

Smart platform for fast development of small-scale integrated continuous downstream processes
Bernt Nilsson, Lund University, Sweden

17:30 - 17:55

Integrated mechanistic modeling to predict a commercial downstream process
Federico Rischawy, Boehringer Ingelheim / Karlsruhe Institute of Technology (KIT), Germany

17:55 - 18:20

Big Data Analytics for Control of Continuous Processes
Anurag Rathore, Indian Institute of Technology Delhi, India

18:45 - 19:15

Cocktail Reception | Tiepolo Terrace (0)

19:15 - 20:30

Dinner | Michelangelo (0)


Poster Snapshot Session & Poster Session | Salone dei Cavalieri (-1)

Session Chairs:

Ana Azevedo, Instituto Superior Tecnico (IST), Portugal
Glen Bolton, Amgen, United States
Marco Rito-Palomares, Tecnologico de Monterrey, Mexico

20:30 - 21:00

Poster Snapshot Session 2
#51. Continuous and integrated processing of viral capsomeres and virus-like particle purification using new generation multi-modal chromatography strategies
Lukas Gerstweiler, University of Adelaide, Australia
#64. To explore novel approaches to remove host cell proteins (HCPs) for antibodies and other Fc fusion proteins’ production
Tingting Cui, AstraZeneca, United Kingdom
#65. Evolution of a clarification platform strategy using a novel chromatographic clarification technology
Agathe Drapé, Sanofi, France
#66. Designing high density isopore membranes with “à la carte” surface chemistries for downstream mAb purification and applications in cell and gene therapies & diagnostics
Daniele Gerion, Terapore Technologies, United States
#70. 3D printed stationary phases for bioseparations: control of morphology across scales, from mm to μm to nm
Simone Dimartino, University of Edinburgh, United Kingdom
#74. Using real-time data to enable smart decision making on the manufacturing floor
Christine O’Sullivan, Amgen, Ireland

21:00 - 23:00

Poster Session 2 with Desserts & Drinks

Thursday 14 July 2022

07:00 - 09:00

Breakfast | Le Bella Arti (-1)


Oral Session 9: New and Transformative Purification Technologies | Salone dei Cavalieri (-1)

Session Chairs:

Raquel Orozco, Bayer, United States
Abraham Lenhoff, University of Delaware, United States

09:00 - 09:05

Introduction by Session Chairs

09:05 - 09:30

Novel Ligands and Modalities for the Purification of Gene Editing Products: CRISPR-Cas and Viral Vectors
Stefano Menegatti, NC State University, United States

09:30 - 09:55

Challenging the Paradigm: An Innovative and Scalable Purification Platform for AAV and Other Biologics
Kelli Luginbuhl, Isolere Bio, United States

09:55 - 10:20

Novel DNA Removal Technology for Exosomes
Aaron Noyes, Codiak BioSciences, United States

10:20 - 10:45

Enabling a design cycle for bioseparation materials with X-ray imaging and 3D printing
Thomas Johnson, University College London (UCL), United Kingdom

10:45 - 11:15

Morning Break | Garden Lobby (-1)

11:15 - 12:45

Roundtables: Yield! | Michelangelo 1/ 2/ 3/ San Pietro (0)
1. Assessing Protein Manufacturability (Chairs: M Butler (Roche), R Willson (U. Houston))
2. Continuous Processing: Opportunities and Challenges (Chairs: K Brower (Sanofi), A Jungbauer (BOKU))
3. Overcoming Constraints in Gene Therapy Manufacture (Chairs: S D'Costa (Alcyone), A Tustian (Regeneron), J Pieracci (Biogen))
4. Manufacturability for Pandemic Preparedness (Chairs: A Rayat (UCL), G Ferreira (AstraZeneca), B Kelley (Vir))

12:45 - 14:15

Lunch Buffet | Le Bella Arti (-1) & Garden Lobby (-1)


Oral Session 10: Impact of Diverse Expression Systems | Salone dei Cavalieri (-1)

Session Chairs:

Jean Bender, Visterra, Inc., United States
Ranga Godavarti, Pfizer, United States

14:15 - 14:20

Introduction by Session Chairs

14:20 - 14:45

The development and manufacture of products from a cell-free expression system
Judy Hsii, Sutro Biopharma, United States

14:45 - 15:10

Insulin Purification – Innovation Continuum via Synthesis of Fundamentals, Technology and Modeling
David Roush, Merck and Co., Inc., United States

15:10 - 15:35

Why Downstream Teams Should Root for Alternative Expression Hosts
J. Christopher Love, MIT, United States

15:35 - 16:05

Afternoon Break | Garden Lobby (-1)


Oral Session 11: Future Facility Design Concepts | Salone dei Cavalieri (-1)

Session Chairs:

Lisa Connell-Crowley, Just - Evotec Biologics, United States
Victor Goetz, Eli Lilly and Company, United States

16:05 - 16:10

Introduction by Session Chairs

16:10 - 16:35

Biopharmaceutical Manufacturing Facilities of the Future: Rigidity, Risk, Resilience, and Veritas' Mirror
Jeffrey Baker, NIIMBL, United States

16:35 - 17:00

Advancing Manufacturing Technology Through a Flexible J.POD® Facility
Robert Casey, Just - Evotec Biologics, Inc., United States

17:00 - 17:25

A truly continuous counter-current downstream
Jon Coffman, AstraZeneca, United States


Keynote | Salone dei Cavalieri (-1)

Host

Nihal Tugcu, Sanofi, United States

17:25 - 18:10

New therapeutic modalities and Moore’s Law in biomanufacturing
Hari Pujar, Tessera Therapeutics and Flagship Pioneering, United States

19:00 - 00:00

Closing Banquet & Awards (Offsite) | Meeting Point: Hotel Lobby (0)

Friday 15 July 2022

07:00 - 10:00

Breakfast & Departures | Le Bella Arti (-1)

10:00

RXIX Conference Close