October 9 – 13, 2022
Sitges, Spain
| Chairs: | Ana Azevedo, Técnico Lisboa, Portugal |
|---|---|
| Jason Walther, Sanofi, USA | |
| Rohini Deshpande, Amgen, USA |
The articles for these proceedings are not peer-reviewed.
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Conference Program, Ana Azevedo, Jason Walther, and Rohini Deshpande (Article)
The Role of Digitalization in the Continuous Integrated Manufacturing of Therapeutic Proteins, Massimo Morbidelli (Abstract)
A truly continuous counter-current downstream, Jon Coffman, Sevda Deldari, Ujwal Patil, Nikunj Sharda, Jitha Sridhar, Keith Morgan, and Irina Ramos (Abstract)
Democratizing global supply of recombinant proteins, Kerry Love (Abstract)
A fully continuous and modular monoclonal antibody purification process with capture via precipitation, Todd Przybycien, Andrew L. Zydney, Steven M. Cramer, and B. Wayne Bequette (Abstract)
Exploring different medium exchange regimes in ultra scale-down models, Marie Dorn, Kerensa Klottrup-Rees, Kenneth Lee, and Martina Micheletti (Abstract)
2-stage continuous growth-decoupled biomolecules production using Escherichia coli – Towards microbial small-footprint manufacturing, Juergen Mairhofer, Patrick Stargardt, Lukas Feuchtenhofer, Florian Weiss, Florian Strobl, Florian Simon, and Gerald Striedner (Abstract)
The multidimensional evolution of ICB: New concepts, technology, and therapeutic modalities, Konstantin Konstantinov (Abstract)
Mechanistic modeling to predict titers and infected cells in the two-stage continuous production of a viral vaccine, Krystian Ganko; Moo Sun Hong; Sangmook Lee; Kaylee C. Schickel; Joules Provenzano; Anthony Grippe; James Wagner; Helen Achwei; David McNally; Stacy L. Springs; Paul W. Barone; and Richard D. Braatz, (Abstract)
Towards an integrated continuous manufacturing process of adeno- associated virus (AAVs), João Mendes, Ricardo J.S. Silv, Cristina Peixoto, António Roldão, and Manuel J.T. Carrondo (Abstract)
Continuous manufacturing of lentiviral vectors, Dale Stibbs, Pedro . Silva Couto, Qasim A. Rafiq, Andrea C. M. E. Rayat, Carme Ripoll Fiol, and Nigel B. Jackson (Abstract)
Progress towards making a global supply of microbial extracellular vesicles,100-times cheaper than a typical biologic, Collin McKenna, Johannes Kung, Fabian R omano-Chernac, Emanuele Leoncini, and Bato Jaric (Abstract)
Looking beyond the horizon: Exosomes at the vanguard of integrated continuous processing of bionanoparticles, Aaron Noyes (Abstract)
A race to contain a global pandemic: The development of the Pfizer/BioNTech mRNA vaccine, Ranga Godavarti (Abstract)
GMP implementation of continuous manufacturing: A case study, Neil Soice (Abstract)
Business case for continuous mAb production with novel design strategies and enhanced control, Catarina Neves and Suzanne S. Farid (Abstract)
Key enablers of continuous manufacturing success through a flexible J.POD® platform, Eva Gefroh (Abstract)
Demonstration of a commercial scale end-to-end continuous purification process, Chad Varner, Akshat Mullerpatan, Sushmitha Krishnan, Michael Coolbaugh, Jason Walther, Kevin Brower, and Shashi Malladi (Abstract)
From lab coats to hard hats: Implementation of GMP continuous manufacturing on the road to commercial readiness, Mark Brower, Lara Fernandez-Cerezo, Nuno Pinto, and William Rayfield (Abstract)
FDA’s progress in advanced manufacturing, Larry Lee (Abstract)
Process intensification: Modeling the impact of technology and process scenario selection on cost, throughput, facility volume, footprint and sustainability, Priyanka Gupta (Abstract)
Development of a flexible and modular approach for integrated continuous biomanufacturing, Michael Coolbaugh, Chad Varner, Xhorxhi Gjoka, Matt Stundtner, Bob Flynn, Raja Jagadesan, Jason Walther, Kevin Brower, and Shashi Malladi (Abstract)
Highly automated bioburden-free continuous manufacturing biologics GMP operations: How to get there?, Lara Fernandez Cerezo, Matthew Serota, Emil Rosenkrantz, Fadlan Saiti, Cyrill Stadelmann, Pius Emmenegger, Andrea Eichenberger, Alex Hoffmann, Tobias Zumbuehl, Susan Brunner, Parinaz Emami, Mihai Buciu, Ivan Krizanovic, Akos Ferenczi, Alexandra David, Adrian Gospodarek, Nuno Pinto, Frankie Pelaez, Will Rayfield, Silvia Sonjak, Scott Hooper, Stefan Weber, Mark Brower, and Matt Kessler (Abstract)
Continuous downstream process of monoclonal antibody developed based on the process analysis/understanding and its validation, Shuichi Yamamoto, Fuminori Konoike, and Noriko Yoshimoto (Abstract and Presentation)
Intensified bioprocessing: Data, data, everywhere..., Marc Bisschops, Mark Schofield, Keith Gillette, Christina Caporale, and Terése Joseph (Abstract)
Pilot-scale integrated continuous biomanufacturing for monoclonal antibodies including mild pH, Veronique Chotteau, Hubert Schwarz, Joaquín Gomis Fons, Madelène Isaksson, Julia Scheffel, Andreas Castan, Sophia Hober, and Bernt Nilsson (Abstract and Presentation)
Design considerations when scaling from 3-L to 3000-L or larger, Kenneth Lee (Abstract and Presentation)
Real-time process analytical technology: Fluorescent dye-based miniaturized sensor for aggregate detection, Mariana Neves Sao Pedro, Michel H.M. Eppink, and Marcel Ottens (Abstract)
Enabling PAT in insect cell bioprocesses: A monitoring toolbox for rAAV production, Inês A. Isidro, Daniel AM Pais, Rui MC Portela, Anastasiya Kryzhanska, Paulo Galrão, Manuel JT Carrondo, and Paula M Alves (Abstract)
Development of the PAT toolkit for continuous bioprocessing, Tiziano Brogna, Jean-Marc Bielser, Arnaud Perilleux, and Tiziano Brogna (Abstract and Presentation)
Advanced process control and process analytical technology for continuous bioprocessing, Lukas Kuerten, Sean Ruane, Bethany Kerr, Daniel Myatt, Vicki Linthwaite, Craig Manning, Harvey Branton, and Simon Hawdon (Abstract)
Model based control of continuous bioprocesse, Anurag Rathore (Abstract and Presentation)
Advanced process control strategies for continuous influenza viral particle production, Pavan Inguva, Kaylee C. Schickel, and Richard D. Braatz (Abstract)
Award Keynote, Veena Warikoo (Abstract)
Automated control of osmolality in a perfusion bioreactor system via in situ conductivity sensors, Amanda Ramsdell, Charles Budde, Ethan Penner, and Daryl Powers (Abstract)
Dissolved oxygen control in intensified perfusion bioreactors at benchtop and pilot scale, Ethan Penner, Jeffrey Swana, Daryl Powers, and Charles Budde (Abstract)
Fully automated on demand cell culture media preparation for perfusion bioreactors, Lisa Wolowczyk, Christian Schultheiss, and Jochen Sieck (Abstract)
Automated sampling in upstream process development for accelerated access to Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), Srijana Chapagain, Rakesh Bobbala, Allyson Caron, and Khin Myint (Abstract)
Transcriptomics and modelling to understand the benefits of low perfusion rate, Meeri Mäkinen, Hubert Schwarz, Veronique Chotteau, Johan Rockberg, Markella Zacharouli, and Magnus Lundqvist (Abstract)
Amino acids and antibody N-glycosylation based on Raman spectroscopy in high cell density perfusion culture, Veronique Chotteau, Meeri E.L. Mäkinen, Andreas Castan, and Hubert Schwarz (Abstract)
Preliminary metabolic screening method for clone selection in the ambr15, Christine Ferng, Ken Lee, and Jon Coffman (Abstract)
Understanding factors that cause product retention and fouling of hollow fiber filters in intensified perfusion processes, Sri Madabhushi, Qianying Zuo, Karthik Jayapal, and Tomas Kasza (Abstract)
Challenges of mass transfer for perfusion cultures in single use bioreactors part 1:Oxygen, Anthony Beaney, Anita Dabek, Mikayla Olin, Anastasia Eftychidou, Natalia Papalamprou, Mauran Mahendra, Joanna Kolacz, and Colin Jaques (Abstract)
Biomanufacturing and testbed development for the continuous production of monoclonal antibodies, Dragana Bozinovski, Elizabeth M. Cummings Bende, Andrew J. Maloney, Jose Sangerman, Alexis B. Dubs, Amos E. Lu, Moo Sun Hong, Nili Persits, Anastasia Artamonova, Rui Wen Ou, Naresh Mohan, Miriam Yanira Nieves, Paul W. Barone, Jacqueline M. Wolfrum, Rajeev J. Ram, Stacy L. Springs, Richard D. Braatz, and Anthony J. Sinskey (Abstract)
Process Analytical Technology (PAT) for automated, real-time control of continuous manufacturing of mAbs, Shantanu Banerjee and Garima Thakur (Abstract)
Advanced control strategies for the continuous production of monoclonal antibodies, Markus Kampmann, Thomas Kruse, Johannes Lemke, David Pollard, and Jonas Austerjost (Abstract and Presentation)
N-mAb: A case study supoorting adoption of integrated continuous bioprocesses, Kevin Brower, Gene Schaefer, and Jennifer L Mantle (Abstract)
Accelerating adenovirus manufacturing by perfusion-based process optimization, Piergiuseppe Nestola, Carina C D Joe, Nitin Chopra, Julia Niemann, Steffi Scholze, Yuanyuan Li, Rameswara R Segireddy, and Alexander D Douglas (Abstract)
Enabling AAV production by transient transfection with high cell density perfusion process, Ye Zhang, Emil Sundäng, and Veronique Chotteau (Abstract)
Process intensification combined with Adaptive Laboratory Evolution enhance VLP- based vaccine candidates production in insect cells, Ricardo Correia, Bárbara Fernandes, Paula M. Alves, and António Roldão (Abstract)
Enhanced process control of an integrated and scalable bioprocess for production and isolation of MSC-derived extracellular vesicles for cardiac repair, Marta Costa, Inês Carrondo, and Enrique Oltra (Abstract)
Integrated & continuous processing: A proven solution to tackle gene therapy manufacturing challenges, Rimenys Carvalho and Tania Pereira Chilima (Abstract)
Pichia pastoris, a promising microbial cell factory for continuous manufacturing, Xavier Garcia-Ortega, José Luis Montesinos-Seguí, and Francisco Valero (Abstract and Presentation)
Do more with less: Fit-for-purpose tools to speed up upstream process development for continuous biomanufacturing, Channing McLaurin, Quang Long Pham, and Jana Mahadevan (Abstract)
Next generation perfusion process development for production of biologics, Jianlin Xu, Jianfa Ou, Khandaker Siddiquee, Emily Rittershaus, Michael Borys, Anurag Khetan, and Yawen Tang (Abstract)
Optimization of a dynamic perfusion process using a combination of high throughput experimentation and hybrid modeling approaches, Maarten Pennings, Jake Chng, Ng Say Kong, Chris McReady, and Gerben Zijlstra (Abstract)
Two small-scale perfusion models for the ambr250 to enable the study of production stability, Sarah Harcum and Srikanth Rapala (Abstract)
Process and cost modeling approaches for manufacturing operations utilizing multi- column chromatography applications, Mattia Sponchioni, Juan Jose Romero Conde, James Angelo, Sanchayita Ghose, Xuankuo Xu, Tae Keun Kim, and Massimo Morbidelli (Abstract)
A scale-down model to investigate cell retention for continuous monoclonal antibody manufacture, Delphine Tavernier, Timothy Erlandson, Daniel Bracewell, and Andrea Rayat (Abstract)
Implementation of intensified and continuous processing to increase yield of lentivirus manufacturing, Keen Chung, Ly Truong, Riaj Mahamud, Philip Yuen, Mike Bransby, and René Gantier (Abstract and Presentation)
Real-time model-based control of single pass tangential flow filtration for production of monoclonal antibodies, Venkataramana Runkana, Garima Thakur, Vishnu Swaroopji Masampally, Amey Kulkarni, Navnath Deore, Anurag Rathore, and Venkataramana Runkana (Abstract and Presentation)
Dynamic process control of continuous twin-column chromatography, Giulio Lievore, Lars Aumann, Thomas Müller-Späth, Richard Weldon, and Sebastian Vogg (Abstract)
Miniaturization of chromatographic process development: Achieving fast results with minimal costs, Tiago Castanheira Silva, Michel Eppink, and Marcel Ottens (Abstract)
Residence time distribution of continuous protein a chromatography, Narges Lali, Peter Satzer, and Alois Jungbauer (Abstract)
Continuous purification of antifungal peptide with a continuous chromatographic system based on fluidized bed technology, Lisa-Marie Herlevi, Guilherme Ferreira, and Hector Marcelo Fernandez Lahore (Abstract)
Design and optimization of membrane chromatography process for monoclonal antibody charge variant separation, Sathish Nadar, Balaji Somasundaram, Marcela Charry, Jagan Billakanti, Evan Shave, Kym Baker, and Linda H.L. Lua (Abstract)
Continuous counter-current affinity colloidal purification, Jon Coffman, Keith Morgan, Irina Ramos, Sevda Deldari, and Jitha Sridhar (Abstract)
Towards implementation of novel single-use devices in integrated processes for biopharmaceuticals, Marina Y. Linova; Edite M. Tiago Gomes Martins; Dan N. Pham; Jinxin Fan; Sobhana A. Sripada; Stefano Menegatti,; Ruben G. Carbonell; and John M. Woodley (Abstract)
Monoclonal antibody purification from gram to kilogram scale utilizing multi-column continuous rProtein A capture, J. Kevin O'Donnell, William Wessel, and Anthony Grabski (Abstract)
Design of a twin-column countercurrent purification (MCSGP) unit for the polishing of an oligonucleotide sequence, Ismaele Fioretti, Thomas Müller-Späth, Richard Weldon, Sebastian Vogg, Massimo Morbidelli, and Mattia Sponchioni (Abstract)
Moving adsorption belt system for continuous bioproduct recovery, Yijia Guo and Hector Marcelo Fernandez Lahore (Abstract)
Continuous vaccine purification utilizing multi-stage aqueous two-phase extraction, Caryn Heldt, Sheridan Waldack, Trisha Colling, Seth Kriz, Caryn Heldt, and Grace James (Abstract)
Feedback control of particle morphology enables continuous monoclonal antibody capture via precipitation, Matthew Mergy, Sambit Ghosh, Mirko J. Minervini, Todd M. Przybycien, Andrew L. Zydney, Steven M. Cramer, and B. Wayne Bequette (Abstract)
Oscillatory flow reactor: A solution for continuous bioprocessing, Diogo Ferreira-Faria, Filipa D. Moreira, M. Raquel Aires-Barros, Ana M. Azevedo, and António Ferreira (Abstract)
Solid polyethylene glycol precipitation: Potential cost reduction in antibody downstream processing, Maria del Carme Pons Royo, Acib; Tommaso De Santis; Daniel Komuczki; Alois Jungbauer; and Peter Satzer (Abstract)
Truly continuous downstream processing of antibodies, overcoming bottlenecks, Gabriele Recanati; Patrick Scheidl; Magdalena Pappenreiter; Bernhard , Sissolak; and Alois Jungbauer (Abstract)
Continuous Counter-current Dialysis (C3D) - the Future of Diafiltration, Irina Ramos, Nikunj Sharda, Irina Ramos, Jon Coffman, and Michelle Chen (Abstract)
A perspective on polishing operations for the continuous removal of process and product related impurities, Steven Cramer (Abstract)
Constant flow rate viral clearance study of Planova™ BioEX virus removal filter and implementation into an integrated process for mAb purification, Hironobu Shirataki (Abstract)
Integration of low-pH viral inactivation and primary clarification processes in a single use disposable biosettle, Dhinakar Kompala and Christopher Glascock (Abstract)
Continuous virus filtration: An existing technology with a promising future, Julie Kozaili, William Rayfield, Mark Brower, Adrian Gospodarek, and Daniel Strauss (Abstract)
Implementation of PAT-based control strategy for continuous formulation, Sushmitha Krishnan, Shashi Malladi, Erin Holahan, Chad Varner, Michael Coolbaugh, Marina Hincapie, Jason Walther, and Kevin Brower (Abstract)
Plug-and-play software for mechanistic modelling of end-to-end continuous manufacturing of monoclonal antibodies, Moo Sun Hong, Amos E. Lu, and Richard D. Braatz (Abstract)
Model assisted design of an intensified bioprocess, Ruth de la Fuente and Marc Bisschops (Abstract and Presentation)
Establishing a highly automated and digitalized end-to-end bioprocess, Martin Purtscher, Manuel Dallinger, David B Nickel, Katerina Petrushevska-Seebach, and Stefan Romeder-Finger (Abstract)
Development and industrialization of advanced biomanufacturing platform to address business needs and affordability of biologics, Christopher Hwang (Abstract)
Successful transition from fed-batch to continuous manufacturing within a mAb process development cycle, Karthik P. Jayapal, Sri R Madabhushi, Michael A Rauscher, and Matthew Manahan (Abstract)
Conversion of an intensified fed-batch to an integrated continuous bioprocess, Brian Follstad, Chris Ford, Neil Kitchen, Rob Piper, Brad Dell, and Lisa Connell-Crowley (Abstract)
A case study: Scale up from bench to 500L of a biologics continuous manufacturing process, Sarwat Khattak and Jennifer Zhang (Abstract)
Overcoming key challenges during the upstream development of a continous manufacturing process at 500L scale, Leon Pybus, Charles Heise, Tibor Nagy, and Jonathan Haigh (Abstract)
Design of an integrated continuous downstream process for emerging acid-sensitive antibodies based on a calcium-dependent protein A ligand, Joaquin Gomis Fons, Madelène Isaksson, Julia Scheffel, Sophia Hober, Anita Solbrand, and Bernt Nilsson (Abstract)
Design & Construction of a truly continuous and fully automated process skid for the production and purification of a monoclonal antibody, Magdalena Pappenreiter, Sebastián Avelino Gómez Sánchez, and Magdalena Pappenreiter (Abstract)
Accelerate process development and transfer for the implementation of integrated continuous biomanufacturing, David Garcia, Nuno Carinhas, Mengyao Li, Aleksandr Pogodaev, Jörg Altekrueger, Thorsten Lorenz, and Tanja Hernandez (Abstract)
Simulated control strategy for product diversion management during continuous processing, Thomas Ransohoff, Behnam Partopour, Ahsan Munir, Thomas Erdenberger, Huanchun Cui, and Rui Wheaton (Abstract)
Bringing flexibility to integrated continuous biomanufacturing, Paul Randolph, Loïc Fejoz, René Reinbigler, Eugene Tung, Christopher Rode, Brian Polilli, and Roger Hart (Abstract)
Pilot scale technical establishment and commercial scale business case on integrated continuous biomanufacturing, Takuo Kawase (Abstract)
Intensified & connected processing for fast, cost effective, and robust monoclonal antibody, Sanket Jadhav, Abijar Bhori, Priyanka Gupta, and Himanshu Gadgil (Abstract)
Cost and life cycle assessment of upstream monoclonal antibody production, Sara Badr, Eri Amasawa, and Hirokazu Sugiyama (Abstract)
Process intensification - So much more than continuous bioprocessing, Niklas Jungnelius and Marc Bisschops (Abstract and Presentation)
Assessing the sustainability of fed batch and continuous process formats for mAb manufacturing via bioprocess modeling, Caroline Mueller, Saman Salike, Megan McClure, Yvenna Chen, Priyanka Gupta, Daniel D'Aquila, Niklas Jungnelius, Lisa Connell-Crowley, and Ken Hamilton (Abstract)