October 20 - 24, 2024
Leesburg, Virginia, USA
| Chairs: | Ana Azevedo, Instituto Superior Técnico, Portugal |
|---|---|
| Aaron Noyes, Apogee Therapeutics, USA | |
| Kevin Brower, Sanofi, USA |
2024 Conference Program - Integrated Continuous Biomanufacturing VI (ICB VI), Ana Azevedo, Aaron Noyes, and Kevin Brower (Article)
Transcriptomics Based-Modeling And Model-Based Medium Optimization Approaches In Perfusion Cultures, Kévin n Colin, Meeri Mäkinen, Yu Wang, Veronique Chotteau, Elling W. Jacobsen, Håkan Hjalmarsson, and Mirko Pasquini (Abstract)
Advances in automation and process control to increase productivity via intensfied fed-batch process for bispecific and monoclonal antibodies, Anthony Beaney, Natalia Papalamprou, Mauran Mahendra, and Sana Shaikh (Abstract)
Early manufacturing insights and clone selection for perfusion processes, Marie Dorn, Kerensa Klottrup-Rees, Kenneth Lee, and Martina Micheletti (Abstract)
DEVELOPMENT OF AN INTEGRATED CONTINUOUS mRNA PRECIPITATION-BASED PURIFICATION PROCESS, Maria del Carme Pons Royo, Allan S. Myerson, and Richard D. Braatz (Abstract)
Accelerated CMC Development of a Complex Therapeutic Protein in Early-Stage Perfusion Cell Culture Development, Amanda Ramsdell, Nathan Ostberg, Yang Wu, and Henry Lin (Abstract)
Column Design and Tracer Considerations for Continuous Packed Bed Viral Inactivation, Innara Basria, Scott Lute, and Opeyemi Ajayi (Abstract and Presentation)
Building the Future of ICB with Lessons from the Past A personal journey in continuous bioprocessing, Charles Cooney (Abstract and Presentation)
The Central Role of Manufacturing for Complex Biologic Products, Peter Marks (Abstract)
Accelerating industry implementation of continuous manufacturing-The key role of dual supply approach from both batch and continuous processes, Takuo Kawase and Yasuharu Shinoda (Abstract)
Modeling of virus contamination for integrated continuous bioprocessing to develop rational strategies for un-processed bulk sampling and downstream clearance, Takao Ito (Abstract)
The regulatory journey for implementation of Integrated Continuous Biomanufacturing for a commercial Enzyme Replacement Therapy product, Rebecca Berger, PhD (Abstract)
Inert tracers for the distribution of residence time distribution in continuous processes: same properties, but still different, Alois Jungbauer, Gabriele Recanati, Narges Lali, Yu-Cheng .Chen, and Dong-Qiang Lin (Abstract)
The future of Biomanufacturing: An FDA Perspective, Riley C. Myers (Abstract and Presentation)
Regulatory Considerations for Design and Implementation of Continuous Viral Inactivation Reactors, Scott Lute (Abstract and Presentation)
Extending the ICB Boundary beyond Drug Substance (Roundtable Workshop), Michael Coolbaugh and Doug Hausner (Abstract and Presentation)
Novel mAb process development blueprint: Unveiling key process parameters that facilitate intensification through integrated continuous bioprocessing, Mark Schofield (Abstract)
Converting a Commercial Fed-Batch Process to Continuous Manufacturing, Andrea Squeri, Robert Luo, Ken Lee, and Jon Coffman (Abstract and Presentation)
Co-current Filtrate Flow in Tff Perfusion Processes: Decoupling Transmembrane Pressure from Crossflow to Improve Product Sieving, Thomas K. Villiger, Patrick Romann, Philip Giller, Antony Sibilia, Andrew L. Zydney, Arnaud Perilleux, and Jean‐Marc Bielser (Abstract)
Low Pressure Operations as Worst-Case Situations for Viral Filtration, Megan McClure, Jodi Chien, and Pippa Bailey (Abstract)
Delivering a Flexible- Modular Skid for Integrated Continuous Purification, Chad Varner, Shashi Malladi, Xhorxhi Gjoka, Akshat Mullerpatan, Matt Stundtner, Michael Coolbaugh, Jerome Chevalier, Jan Schaefer, Stefanie Helling, Jason Walther, and Kevin Brower (Abstract)
Hybrid deep learning model for in- silico optimization of a dynamic perfusion cell culture process, Barney Zoro, Piyush Agarwal, Chris McCready, Ng Say Kong, Jake Chng, Maarten Pennings, Jeroen van de Laar, and Gerben Zijlstra (Abstract)
Model-based design of a platform for continuous production of recombinant adeno-associated virus, Francesco Destro, Richard D. Braatz, Anthony J. Sinskey, Stacy L. Springs, Paul W. Barone, Jacqueline M. Wolfrum, and John Joseph (Abstract)
Continuous production of Influenza virus-like particles using IC-BEVS and multi-stage, cascaded bioreactors, Ricardo Correia, Taja Zotler, Miguel Graça, Bárbara Fernandes, Gorben Pijlman, Paula M. Alves, and António Roldão (Abstract)
High Agitation Adaptation as a Framework for Next Generation Manufacturing Clone Selection, Maxine Annoh, Samik Das, Jon Coffman, and Ken Lee (Abstract)
3000-L Scale perfusion demonstration and its implication to end-to-end continuous downstream design, Nuno Pinto (Abstract)
Development of a highly concentrated supplement to decrease volumetric media demand in perfusion, Mona Bausch, Channing McLaurin, Long Pham, Lisa Wolowczyk, Jana Mahadevan, Luis Ayala, and Jochen B. Sieck (Abstract)
Autonomous operation and quality monitoring of a continuous antibody downstream process, Madelène Isaksson, Bernt Nilsson, Niklas Andersson, Maja Sondell, Julius Klemens Lorek, and Daniel Espinoza (Abstract and Presentation)
Advanced Control Strategies for Lab-Scale End-to-End Continuous Biomanufacturing, Thomas Kruse, Jonas Austerjost, Markus Kampmann, David Pollard, and Elias Knöchelmann (Abstract and Presentation)
Evolving Integrated Continuous Biomanufacturing Control Strategies through Digital twins, Tiago Matos, Umme Amira, Natalie Al Inati, Juan Marin-Celis, Scott Hatch, Robert Taylor, Fay Metsi-Guckel, Jasdeep Mandur, Nuno Pinto, Mark Brower, Krunal Metha, and Avik Sarkar (Abstract)
Demonstration of an integrated and continuous monoclonal antibody purification process with capture via precipitation, Matthew R. Mergy, Mario A. Gutierrez-Diaz, Yuncan Zhu, Mirko Minervini, Ali Behboudi, Steven M. Cramer, Todd M. Przybycien, and Andrew L. Zydney (Abstract)
Leading Innovation: Exploring Optimistic Futures, Dava Newman (Abstract)
Environmental impact evaluation of fed-batch vs intensified, continuous mAb manufacturing with a life cycle assessment tool, Lisa Connell-Crowley, Bill Flanagan, Angela Fischer, Dan D’Aquila, Barry Dillon, and Ken Hamilton (Abstract)
Innovative Solutions for an Agile and Sustainable Facility: Mechanical Recycling of Post-Use Bioprocessing Plastic Containers— Mechanical Recycling Technical Feasibility’ A Sanofi/Sartorius/Veolia collaboration, Miriam Monge, Simon Massot, Estelle Doger, and Jean-Michel Brossard (Abstract)
Defining an ideal future for reduction, recycling and circularity of single use plastics, Lisa Connell-Crowley, Lacy Linney, and Magali Barbaroux (Abstract)
Toward a truly continuous downstream using affinity nanoparticles and affinity precipitation, Jon Coffman (Abstract)
Leveraging Continuous Unit Operations to Enable a Higher-Yielding Virus-Like- Particle (VLP) Purification Process, Adam Kristopeit, Kabir Dhingra, Henry Ludwicki, Nicholas Samuelson, and Mark Brower (Abstract)
Continuous Decapping Using PAT: Stepping Towards Integrated mAb & ADC Process, Rebecca Chmielowski, Jay Desai, Bruce Kilgore, Andrew Semple, Andrew Bochnovich, Nicole Cheney, Greg Hughes, Sanjeev Ahuja, Mark Brower, Lara Fernandez Cerezo, and Collette Cutler (Abstract)
Model-based design of continuous reactor configurations for production of mRNA, Nathan Stover and Richard Braatz (Abstract)
Adeno-associated virus production intensification by continuous bioprocess with repeated transfections in high cell-density perfusion bioreactors, Ye Zhang, Olivér Daoda, and Veronique Chotteau (Abstract)
ECONTI - Advancing Integrated Continuous Manufacturing with Microbial Cells: An Update, Jürgen Mairhofer, Florian Simon, Johanna Berein, Florian Weiss, Natalia Danielewicz, Patrick Stargardt, and Gerald Striedner (Abstract)
Integrated continuous biomanufacturing of hIPSC-derived cardiomyocytes and extracellular vesicles, Margarida l Serra, Paula M. Alves, Pedro Vicente, Lara Inocêncio, Ana Meliciano, João Jacinto, Ana F. Louro, Regen. Med, Manuel Mazo, Asier Agote, Olalla Iglesias, Patxi Martin-Uriz, Felipe Prosper, Joost Sluijter, and Alain van Mil (Abstract)
Toward a truly continuous downstream using affinity nanoparticles and affinity precipitation, Jon Coffman, Ujwal Patil, Kareem Fakhfakh, Joel Graham, Irina Ramos, Carrie Sowers, Lauren Leisen, Makenzie Lewis, Brendan Kuntz, Michelle Chen, Alison Hinton, Taylor Bloom, and Keith Morgan (Abstract)
Challenges and Opportunities in the Manufacturing of Cellular Protein, Yaakov Nahmias (Abstract)
ICB Risk Assessment: Case Studies in Practice (Roundtable Workshop), Gene Schaefer and Kelly Wiltberger (Abstract and Presentation)
Next Gen Flexible Facility for ICB or Batch, Enabling Technologies and Economics, John Erickson, Michael Bartkovsky, Carrington Edmunds, Ken Hamilton, Xuan Han, Brian Horoswki, Jeff Johnson, Kelvin Lee, Steve Mehrman, Behnam Partopour, Tom Piombino, Pat Ryan, Melissa Scott, Raymond Szuszkiewicz, and Juan Torres (Abstract)
Implementation of Integrated Continous Biomanufacturing at Novartis - our journey, David Garcia, Tanja Hernandez, Adriano del Priore, Patrick Salou, Jörg Altekrueger, and Sebastian Ruegger (Abstract)
GMP Implementation of Continuous Manufacturing, Edward Wong, Madiha K hurshid, and Vivek Kumar (Abstract)
Role of Spectroscopy for Real Time Monitoring and Control of Continuous Bioprocesses, Anurag Rathore (Abstract and Presentation)
Integrated Continuous Biomanufacturing: Perspectives from the Manufacturing Floor, Chetan Goudar (Abstract)
Mechanistic modeling, state estimation, and control of continuous lyophilization, Prakitr Srisuma, George Barbastathis, and Richard D. Braatz (Abstract)
A fully automated perfusion process using Raman spectroscopy, Anita Kundu, Ashna Dhingra, Jon Coffman, Ken Lee, Matt Radle, Elise Woodall, Andrea Squeri, Jana McGuin, and Patrick Haggerty (Abstract)
A novel approach for instant implementation of Raman-based PAT with integrated real-time process control, Graziella Piras, Stephanie Klaubert, Colin Gavin, Stephen Driscoll, Nick Randall, Milla Neffling, Christopher Brown, and Awab Nehela (Abstract)
Continuous Biomanufacturing with K. phaffii (P. pastoris): Perfusion Process Development and Downstream Considerations for Therapeutic Protein Production, Marina Y. Linova, Satish K. Kodiripaka, Edite M. Tiago Gomes Martins, Dan N. Pham, Sobhana A. Sripada, Stefano Menegatti, Ruben G. Carbonell, and John M. Woodley (Abstract)
The RABBIT jumps ahead - Rapid A BioSMB Biolayer Interferometry Technology, Thomas Kruse, Markus Kampmann, and Fabian Schmitz (Abstract and Presentation)
Digital Twin of a Continuous Antibody Capture Step, Bernt Nilsson, Maja Sondell, Niklas Andersson, and Julius Klemens Lorek (Abstract)
End-to-end continuous bioprocess automation with central data management, Wolfgang Sommeregger, Katrin Illner, and Natasa Gutmann (Abstract)
Cost reduction and optimization of CHO mAb-producing perfusion cell culture by identifying viability-limiting media components, Milla Neffling (Abstract)
Effect of glucose and amino acids on volumetric and cell specific productivity, Sarah Harcum and Srikanth Rapala (Abstract)
Development of In-line Viral Inactivation (iVI) System for Enabling Integrated Continuous Processing, Santosh B. Rahane, Thomas Coton, Lauriane Gaudette, Alexander Jensen-Fellows, Karine Elise Voltz, Elizabeth Goodrich, and Kristen Cotoni (Abstract)
Model-based optimization and control of single pass tangential flow filtration (SPTFF) of monoclonal antibodies, Venkataramana Runkana, Yukta Bhange, Venkata Sudheendra Buddhiraju, and Srinivas Diwanji (Abstract)
Modeling of a Bioreactor for Production of Monoclonal Antibodies, Venkataramana Runkana, Venkata Sudheendra Buddhiraju, Venkataramana Runkana, and Srinivas Diwanji (Abstract)
Implementation of Raman Spectroscopy for in-line monitoring of critical process parameters of CHO cell perfusion cultures, Ushma Mehta (Abstract and Presentation)
Automation of Perfusion Rate Control for Maintaining a Constant Cell Specific Perfusion Rate to Decrease Media Demand, Niklas Welzenbach, Lisa Wolowczyk, Mona Bausch, Luis Ayala, and Jochen Sieck (Abstract)
Increasing Upstream Yield through Bleed Recovery in Perfusion Processes, Lisa Wolowczyk, Luis Ayala, Jochen B. Sieck, Mona Bausch, and Niklas Welzenbach (Abstract)
Optimization of an Integrated Continuous Biomanufacturing Process to Improve Consistency of a Critical Quality Attribute, Charles Budde, Tom Hayes, Stephanie Riley, and Amanda Ramsdell (Abstract)
Mechanistic Modelling, Uncertainty Analysis, and Advanced Process Control of Particle Size Distribution in Continuous Tubular Protein Precipitation, Krystian Ganko (Abstract)
Setting up a continous downstream bioprocessing lab platform from an automation perspective, Hafsah Rai, Sofia Nunes, Jean Aucamp, and Sandeep Hadpe (Abstract)
Raman spectroscopy implementation for highly concentrated drug substances, Alexander Farris and James Angelo (Abstract)
Mechanistic modeling strategies for continuous lipid nanoparticle manufacturing, Pavan K. Inguva, Saikat Mukherjee, Jie Wang, Yanchen Wu, Mona A. Kanso, Vico Tenberg, Srimanta Santra, Shalini Singh, Allan S. Myerson, Pierre J. Walker, and Richard D. Braatz (Abstract)
Retooling membrane adsorbers for continuous chromatography: Fitting a square peg into a round hole, David Latulippe, Claire Velikonja, Ian Gough, Landon Steenbakkers, Joshua How, Prashant Mhaskar, Mackenzie Enns, Brandon Corbett, and Chris McCready (Abstract)
Heterogeneity in Adeno-Associated Virus Transfection-Based Production Process Limits the Production Efficiency, Brian Ladd, Sofia Tunmats, and Veronique Chotteau (Abstract)
Twin-column Continuous Chromatography for Improving Viral Vector Based Gene Therapies, Thomas Villiger, Julia Müller, Daniela Tobler, Kateřina Klausová, Richard Plieninger, Tereza Müllerová, Jules Bühler, Yuki Higuchi, Sebastian Vogg, and Thomas Müller-Späth (Abstract)
Enhancing AAV production: Impact of integrated and continuous strategies on process economics, Ruth de la Fuente Sanz (Abstract)
ECOnti – Accelerated, low ecological footprint, manufacturing platform for continuous production of biotechnological products using microbial cells, Florian Simon, Patrick Stargardt, Jürgen Mairhofer, Johanna Berein, Florian Weiss, Natalia Danielewicz, and Gerald Striedner (Abstract)
Reviewing the process intensification landscape through the introduction of a novel, multitiered classification fordownstream processing, Paul Cashen, Marc Noverraz, and Martin Lobedann (Abstract)
Cell retention investigations at different development scales to inform perfusion scale-up, operation and impact on downstream processing, Delphine Tavernier, Timothy Erlandson, and Andrea Rayat (Abstract)
Mechanistic Modeling to Quantify Starling Flow in Hollow Fiber Membranes Used for Tangential Flow Filtration (TFF) in Perfusion Processes, Ashna Dhingra, Michael Mollet, Ken Lee, and Jon Coffman (Abstract)
A 30 kg/day one-step process for continuous concentration, buffer exchange, and formulation of biologics, Ujwal Patil, Michelle Chen, Jon Coffman, and Irina Ramos (Abstract)
VMF: Disruptive Vibro\n®\n technology for continuous biomanufacturing processes, Jarno Robin (Abstract)
Downstream Process Intensification Toolbox, Jérôme Chevalier, Stuart Tindal, Kevin Brower, Cyril Mak, Fabrizio Pelella, Nitin Chopra, and Karl Rogler (Abstract)
Developing a Control Strategy for integrated semi-continuous bioprocessing, Charles Heise (Abstract)
Application of upstream and downstream filtration technologies as solutions for continous bioprocessing, Julie Kozaili and Daniel Strauss (Abstract)
Evaluation of integrated continuous downstream process of monoclonal antibody developed based on the process characterization, Shuichi Yamamoto, Fuminori Konoike, and Noriko Yoshimoto (Abstract)
Fouling of hollow fiber filters in high cell density perfusion processes – A systematic study to identify causes and strategies to improve filter performance, Sri Madabhushi, Qianying Zuo, Chelsea Phuangthong, Nathaniel Ruppert, and Carol Zhao (Abstract)
Evaluation of High Throughput Scale-Down Models and Scale-Up of an Intensified Dynamic Cell Culture Platform Process, Jennifer Nguyen, Matthew Gagnon, Wenge Wang, Arch Creasy, Alaina Anand, Jeff Salm, and Aravindan Rajendran (Abstract)
10x in Three Months, the Power of High-density Perfused Batch in Scale down Models, Ethan Bossange, Joseph Shultz, Huanchun Cui, and Andy Grube (Abstract)
De-bottlenecking the UF/DF steps- Enhancing Recovery and Efficiency in a Continous Downstream Process, Prateek Joshi (Abstract)
Continuous Viral Inactivation using a 3D-Printed Gyroid Column, Kareem Fakhfakh, Irina Ramos, and Jon Coffman (Abstract)
Solving the separation challenge in perfusion: Lab-scale verification and pilot scale implementation, Andreas Andersson, Henrik Maude, Andreas Castan, Neil Ross, and Patrick Romann (Abstract)
Scaling Up Continuous Bioprocessing: Insights from Small-Scale Production, Bea Portez; Alexander Noonan,; Akshat Mullerpatan; Yang Wu; Jesse Keegan; and Mark Roper (Abstract and Presentation)
Overcoming scale-up challenges in perfusion culture, HIROKATSU MAKITSUBO, Wataru Tanaka, Atsushi Kuwahara, Ayaka Tomihari, Haruka Sano, Yuta Hasunuma, Ryota Nakajima, Yasuharu Shinoda, Akihiko Ban, and Kiyoshi Hirakawa (Abstract)
Implementation challenges of an ultra-high density continuous biomanufacturing process, Xiaoxia Jin (Abstract)
Development and Implementation of a Generalized Framework for Integrated Process Design to Enable Flexible Biomanufacturing, Shashii Malladi, Chad Varner, Michael Coolbaugh, Jason Walther, Kevin Brower, and Xhorxhi Gjoka (Abstract)
Enhanced mAb polishing: novel perspectives for continuous processes, Baptiste Balbuena and Sébastien Delacroix (Abstract)
Eco-Design: Alternatives to Process Mass Intensity in Assessing the Impact Of Bioprocessing, Andrew Sinclair, Claire Hill, Yuki Abe, and Sa’ad Ojeilli (Abstract and Presentation)
Practical process validation approach for continuous bio manufacturing, Moe Matsushita and Takuo . Kawase (Abstract)
Quantitative reproduction of virus filter filtration behavior, virus removability, and protein/virus retention distribution within the virus filter using an advanced multilayer membrane model, Hironobu Shirataki (Abstract)
Machine Learning Driven (bio)process Exploration, Matteo Planchestainer, Corentin Briat, Colin Jaques, and Thomas K. Villiger (Abstract)
Workshop - Sustainability (Training Workshop), sponsored by EVOTEC, Sara Badr and Priyanka Gupta (Abstract and Presentation)