September 17-21, 2017 - Hotel Cascais Miragem, Cascais, Portugal

Editors:   Suzanne Farid, University College London, United Kingdom
  Chetan Goudar, Amgen, USA
  Paula Alves, IBET, Portugal
  Veena Warikoo, Axcella Health, Inc., USA

The articles for these proceedings are not peer-reviewed.

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Conference Program, Suzanne Farid, Chetan Goudar, Paula Alves, and Veena Warikoo (Article)

Are we prepared to meet the demands of a challenging, but promising future?, James N. Thomas (Abstract)

Continuous bioprocessing for biologics manufacturing, Hang Zhou and Weichang Zhou (Abstract)

Development of highly intensified cell culture perfusion media and process with tremendous productivity potential, while having a low cell bleed requirement for maintaining an overall high yield, Henry Lin, Samantha Wang, Daisie Ogawa, Lili Zheng, Janani Ravikrishnan, and Jon Coffman (Abstract)

Scalable technologies for process intensification in the continuous biomanufacturing factories of the future, Gerben Zijlstra (Abstract)

Process development in screening scale bioreactors and perspectives for very high cell density perfusion, Veronique Chotteau (Abstract)

Evaluating options objectively – Resisting the "purist" approach to arrive at the most productive, robust, and practically implementable perfusion utilizing processes, Gregory Hiller and Henry Lin (Abstract)

Systemic rejuvenation: From blood to molecular therapies, Ludwig Aigner (Abstract)

Development of continuous production and purification processes for the integrated manufacture of monoclonal antibodies, Fabian Steinebach, Daniel Karst, Nicole Ulmer, Moritz Wolf, Sebastian Vogg, and Massimo Morbidelli (Abstract)

From development to implementation with a fully integrated downstream bioprocess, Jeff Salm, Rob Fahrner, Raquel Orozco, Min Zhang, Marcus Fiadeiro, Jill Kublbeck, Scott Godfrey, Bob Kottmeier, Dave Sullivan, Jon Coffman, and Samet Yildirim (Abstract)

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Process intensification: Enabling technologies and methodologies, Jonathan Souquet, Xavier LeSaout, and Herve Broly (Abstract and Presentation)

A disruptive alternative to semi-continuous multi-column chromatography (MCC) processes, Michael Rose, Chris Le Page, and Mark Pearce Higgins (Abstract)

Multi-column chromatographic purification of influenza virus-like particles, Sofia Carvalho, Ricardo Silva, Cristina Peixoto, Paula Alves, and Manuel Carrondo (Abstract)

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Fouling mitigation in membrane based perfusion systems by oscillating tangential flow, Maria Weinberger and Ulrich Kulozik (Abstract and Presentation)

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Bioprocess intensification and optimisation using macroscopic predictive models of cell culture processes, Bassem Ben Yahia, Boris Fessler, Gwendal Gränicher, An-vy Tran, Mareike Harmsen, and Elmar Heinzle (Abstract and Presentation)

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Use of a biphasic perfusion process based on mild hypothermia for recombinant glucocerebrosidase (GBA) production, Filipa M. Gonçalves, Leda R. Castilho, and Juliana Coronel (Abstract and Presentation)

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Ultra scale-down mimics for perfusion culture: Experimental study for rapid biopharmaceutical process development, Molly Tregidgo, David Pollard, and Martina Micheletti (Abstract and Presentation)

Evaluation of pseudo-perfusion feeding strategies for mAb production using a CHO cell line adapted to concentrated feed media, Leda R. Castilho, Ioná W. Bettinardi, and Vitória São José (Abstract)

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Conversion of an industrial batch separation process to an autonomous integrated downstream process – A case study Anton Lofgren, Lund University, Sweden, Anton Löfgren, Niklas Andersson, Joaquin Gomis Fons, Anton Sellberg, and Bernt Nilsson (Abstract and Presentation)

Continuous protein precipitation – A robust antibody purification method without the need for steady state conditions during continuous integrated production., Daniel Burgstaller, Peter Satzer, Steffen Großhans, Simon Caserman, and Alois Jungbauer (Abstract)

Continuous extraction strategies for monoclonal antibodies: From macro- to micro- scale, Ana M. Azevedo and M. Raquel Aires-Barros (Abstract)

Design of a novel continuous flow reactor for low pH viral inactivation, Stephanie A. Parker; Raquel Orozco; Linus Amarikwa,; Scott Godfrey; Jon Coffman; Parviz Shamlou; and Cameron L. Bardliving (Abstract)

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Supervisory control of integrated continuous downstream processes, Bernt Nilsson, Niklas Andersson, Joaquin Gomis Fons, and Anton Löfgren (Abstract and Presentation)

Digitalization platform and supervisory control of a continuous integrated bioprocess based on Raman spectroscopy, Fabian Feidl, Michael Sokolov, Sebastian Vogg, Moritz Wolf, Alessandro Butté, and Massimo Morbidelli (Abstract)

Up and down scale considerations for the continuous production of glycooptimized biopharmaceuticals, Steffen Kreye and Rainer Stahn (Abstract)

Scalable lentiviral vector production using stable producer cell lines in perfusion mode, Aziza Manceur, Stéphane Lanthier, Sonia Tremblay, July Dorion-Thibaudeau, Julia Transfiguracion, Hafida Aomari, Rénald Gilbert, and Sven Ansorge (Abstract)

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Continuous gas processing without bubbles using thin liquid film bioreactors containing biocomposite biocatalysts, Michael C. Flickinger, Christopher Duran, Adam Wallace, Mark J. Schulte, Orlin D. Velev, Nilay Chakraborty, Michael Guarnieri, and Kamelia Boodhoo (Abstract and Presentation)

Enabling next-generation cell line development using continuous perfusion and nanofluidic technologies, Chetan Goudar, Jennitte Stevens, Kim Le, Shivani Gupta, Christopher Tan, and Trent Munro (Abstract)

Towards the implementation of a continuous bioprocess in single use technology, Jorgen Magnus, Maike Temming, Peter Schwan, Viktorija Kistler, Stefan Sievers, Martin Poggel, Thomas Daszkowski, and Martin Lobedann (Abstract)

Implementation of an end-to-end continuous bioprocessing platform using novel technologies, Peter Levison, Mark Schofield, Rene Gantier, and Xhorxhi Gjoka (Abstract)

Fully integrated continuous antibody processing demonstrates improved productivity, Kenneth Lee, Joanna Pezzini, Lindsay Arnold, Jeong Lee, Jim Dyer, Venkat Raghavan, and Jean Bender (Abstract)

Balancing continuous, integrated, and batch processing, Jon Coffman, Henry Lin, Samantha Wang, Scott Godfrey, Raquel Orozco, Samet Yildirim, Jeff Salm, Greg Hiller, Matt Gagnon, Rob Farner, Bob Kottmeier, and Dave Sullivan (Abstract)

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Continuous freeze-drying and its relevance to the pharma/biotech industry, Roberto Pisano, Luigi C. Capozzi, and Bernhardt Trout (Abstract and Presentation)

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Continuous manufacturing - EMA perspective and experience, Nino Mihokovic (Abstract and Presentation)

Continuous bioprocessing and process analytical technologies: A path towards quality by design, Nuno Pinto, Mark Brower, Adrian Gospodarek, William Napoli, David Pollard, and Douglas Richardson (Abstract and Presentation)

Commercialization of a 2nd generation intensified perfusion process during life cycle management, Jiuyi Lu, Myles Hollenbach, Jonathan Wang, Jason Walther, and Jean McLarty (Abstract)

Regulatory aspects of continuous downstream processing, Marc Bisschops (Abstract)

Integrating analysis with process control for continuous bioprocessing: Extending the lifecycle concept to process analytical technologies, José C. Menezes, Pedro M. Felizardo, and Francisca F. Gouveia (Abstract)

A comprehensive study in PAT-applications for a QbD-compliant development of continuous biopharmaceutical production, Reiner Luttmann, Jens Fricke, Sven-Oliver Borchert, and Jan-Patrick Voss (Abstract)

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Delivering a toolbox of flexible platforms for clinical and commercial bioprocessing production: ‘Defining the business drivers for development and implementation’, Mark Brower and David Pollard (Abstract and Presentation)

Are integrated processes a solution looking for a problem to solve, or a tool to solve the problem?, Joseph Edward Shultz, David Garcia, Rui Dos Reis Rodrigues, and Huanchun Cui (Abstract)

Process economics in biologics manufacturing, John Machulski (Abstract)

Next generation manufacturing for biologics: Integration of a hybrid model for continuous manufacturing concepts into a clinical facility, Michael Borys, Sanchayita Ghose, Joon Chong Yee, Frank Ritacco, Srinivas Chollangi, Xuankuo Xu, James Angelo, Nripen Singh, Timothy Erlandson, Jita Ray, and Zheng Jian Li (Abstract)

Beyond CHO – Non-mammalian hosts could be the future expression systems of choice for recombinant biotherapeutics, Chapman Wright, Carl Co, Matthew Westoby, Venkatesh Natarajan, Heather Saforrian, Andrew Horwitz, Jeff Ubersax, and Christopher Love (Abstract)

Integrated manufacturing with microbial hosts for fast process development and production, J. Christopher Love (Abstract)

Continuous biomanufacturing concepts for cell therapy processes, Erika McAfee (Abstract)

Bioprocess intensification for the continuous expansion of 3D human induced pluripotent stem cell aggregates in bioreactors, Bernardo Abecasis, Tiago Aguiar, Émilie Arnault, Rita Costa, Patricia Gomes-Alves, Margarida Serra, Paula M. Alves, and Anders Aspegren (Abstract)

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Development and large scale manufacturing of exosome-based therapeutics, Konstantin Konstantinov (Abstract and Presentation)

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Optimizing media for perfusion combining predictive scale-down models and multivariate approaches, Jochen Sieck, Christian Schultheiss, and Pedro Felizardo (Abstract and Presentation)

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Development of a scale down toolbox for perfusion process development, Jean-Marc Bielser (Abstract and Presentation)

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Development and application of screening scale bioreactor systems for very high cell density perfusion of mammalian cells, Caijuan Zhan, Hubert Schwarz, Magnus Lundqvist, Atefeh Shokri, Ray Field, Richard Turner, Mathias Uhlén, Johan Rockberg, and Veronique Chotteau (Abstract and Presentation)

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Fouling mitigation in membrane based perfusion systems by oscillating tangential flow, Maria Weinberger and Ulrich Kulozik (Abstract and Presentation)

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Bioprocess intensification and optimisation using macroscopic predictive models of cell culture processes, Bassem Ben Yahia, Mareike Harmsen, An-vy Tran, Gwendal Gränicher, Boris Fessler, and Elmar Heinzle (Abstract and Presentation)

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Ultra scale-down mimics for perfusion culture: Experimental study for rapid biopharmaceutical process development, Molly Tregidgo, Martina Micheletti, and David Pollard (Abstract and Presentation)

Evaluation of pseudo-perfusion feeding strategies for mAb production using a CHO cell line adapted to concentrated feed media, Leda Castilho, Vitória São José, and Ioná W. Bettinardi (Abstract)

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Use of a biphasic perfusion process based on mild hypothermia for recombinant glucocerebrosidase (GBA) production, Filipa Gonçalves, Juliana Coronel, and Leda R. Castilho (Abstract and Presentation)

Enhancing crispr-mediated CHO cell antibody productivity through concentrated fed- batch or continuous perfusion, Ching-Jen Yang, Ming-Hung Hsu, Hsin-Lin Lu, Dalton Chen, Hsueh-Lin Lu, and Wei-Kuang Chi (Abstract)

Evaluation of cell culture with a simulated continuous manufacturing (sCM) process in 50mL tubespins for clone selection, Natalia Gomez, Jonathan Lull, Mike Pritchard, and Kristi Daris (Abstract)

Screening cell growth in simulated continuous manufacturing spin tubes determines optimal media conditions for cell lines, Jonathan Lull, Michael Shearer, Luis Diaz, Natalia Gomez, Mike Pritchard, and Chetan Goudar (Abstract)

Development of a novel automated perfusion mini bioreactor ‘ambr® 250 perfusion, Barney Zoro and Andrew Tait (Abstract)

More than 15 years of continuous processing using chemostat cultures. A Shire niche?, Daniel Fleischanderl (Abstract)

Small-scale development and optimization of stirred tank mammalian cell perfusion cultures, Moritz Wolf, Massimo Morbidelli, and Daniel Karst (Abstract)

Intensification of a multi-product perfusion platform through medium and process development, Shawn Barrett, Andrew Chang, and Nathan Bandow (Abstract)

Computational Fluid Dynamics (CFD) modelling and experimental confirmation of hollow fiber tangential flow filtration (HFTFF) and alternating tangential flow filtration (ATF) In a perfusion bioreactor, Flaka Radoniqi, Samantha Wang, Jon Coffman, Arash Abedijaberi, Cameron Bardliving, Parviz A. Shamlou, and Hu Zhang (Abstract)

Up and down scale considerations for the continuous production of glycooptimized biopharmaceuticals, Steffen Kreye and Rainer Stahn (Abstract)

Ultra scale-down concepts to address early stage process development challenges in integrated continuous bioprocessing, Andrea CME Rayat and Gary J. Lye (Abstract)

Continuous protein precipitation – A robust antibody purification method without the need for steady state conditions during continuous integrated production, Daniel Burgstaller, Peter Satzer, and Alois Jungbauer (Abstract)

Continuous in-line virus inactivation for next generation bioprocessing, Melissa Holstein, Christopher Gillespie, Lori Mullin, Ronald Tuccelli, John Caulmare, Luc Messier, and Michael Phillips (Abstract)

Consideration of filter design space for validation of virus filtration in continuous processing applications, Nigel Jackson (Abstract)

Impact of product and recycle times in MCSGP polishing on charge variant separation, Sebastian Vogg, Nicole Ulmer, Fabian Steinebach, and Massimo Morbidelli (Abstract)

Novel single-column simulated moving-bed chromatography platform for quasi- continuous biopurification, José P. B. Mota, Abimaelle Chibério, Cristina Peixoto, and Manuel Carrondo (Abstract)

Design of a novel continuous flow reactor for low pH viral inactivation, Stephanie A. Parker, Parviz Shamlou, Cameron L. Bardliving, Raquel Orozco, Scott Godfrey, Jon Coffman, and Linus Amarikwa (Abstract)

Progress towards continuous aqueous two-phase extraction via TAPPIR, Andreas S. Bommarius, Bettina R. Bommarius, Juliane Merz, Carolin Stark, and Gerhard Schembecker (Abstract)

Continuous extraction strategies for monoclonal antibodies: From macro- to micro- scale, Ana M. Azevedo and M. Raquel Aires-Barros (Abstract)

Enabling end-to-end continuous biomanufacturing by exploring integration approaches of continuous TFF, Dejan Arzensek (Abstract)

Viral clearance considerations for continuous viral inactivation, Raquel Orozco, Linus Amarikwa, Stephanie Parker, Scott Godfrey, Marcus Fiadeiro, Rob Fahrner, Jeff Salm, and Jon Coffman (Abstract)

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Conversion of an industrial batch separation process to an autonomous integrated downstream process – A case study, Anton Lofgren, Niklas Andersson, Joaquin Gomis Fons, Anton Sellberg, and Bernt Nilsson (Abstract and Presentation)

Much-efficient and cost-effective manufacturing of antibody biotherapeutics employing integrated negative chromatography technology, Mariangela Spitali, Razwan Hanif, Nicola Roberts, Tara Lansink, Anna Trzuskolas, and Chad Zhang (Abstract)

A fully continuous downstream process concept without column chromatography, Todd Przybycien, Qin Gu, Zhao Li, and Andrew Zydney (Abstract)

Dynamic process control of twin-column periodic countercurrent chromatography processes, Thomas Müller-Späth and Massimo Morbidelli (Abstract)

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Application of single pass TFF to enable intensified and continuous biological manufacturing, Herb Lutz (Abstract and Presentation)

Development of an N-1 perfusion process and optimized scale-down models for implementation in a platform CHO cell culture manufacturing process, Frank V. Ritacco, Yongqi Wu, Luzmary Sabino, Mina Chaudhry, Tim Erlandson, Joon Chong Yee, Anurag Khetan, and Zhengjian Li (Abstract)

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Process considerations for Protein A affinity capture, virus inactivation, and linked polishing steps in multi-column continuous purification of monoclonal antibodies, Robert Mierendorf, Tom Van Oosbree, Anthony Grabski, William Wessel, and Emily Schirmer (Abstract and Presentation)

Continuous purification of monoclonal antibody using periodic counter-current chromatography, Wei-Kuang Chi, Ho-Lung Jiang, Yue-Chang Chou, and San-Cher Chen (Abstract)

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Clarification and capture of a CHO-derived monoclonal antibody through flocculation and AEX processes, Rimenys J. Carvalho and Leda Castilho (Abstract and Presentation)

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Supervisory control of integrated continuous downstream processes, Bernt Nilsson, Anton Löfgren, Joaquin Gomis Fons, Niklas Andersson, and Lotta Berghard (Abstract and Presentation)

Process analytical technologies for a continuous capture and connected downstream process, Nina Brestrich, Herve Moebel, Iso Lengwiler, Huanchun Cui, and Joseph Shultz (Abstract)

Digitalization platform and supervisory control of a continuous integrated bioprocess based on raman spectroscopy, Fabian Feidl, Michael Sokolov, Sebastian Vogg, Moritz Wolf, Alessandro Butté, and Massimo Morbidelli (Abstract)

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Process analytical technology (PAT) in continuous bioprocessing, Edita Botonjic-Sehic (Abstract and Presentation)

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Qualification of single use in-line sensors for use in continuous bioprocessing, James Furey, Dennis Annarelli, and Josh Huang (Abstract and Presentation)

Time-series datamining for continuous bioprocess analysis, Yang Yang and Suzanne S. Farid (Abstract)

Enhancing multivariate calibration model reproducibility for the online monitoring of upstream processes in continuous biomanufacturing, Nicholas Trunfio, Brittany Chavez, SaiRashmika Velugula, Cyrus Agarabi, and Seongkyu Yoon (Abstract)

FDA/OBP laboratory research to support continuous bioprocessing, Scott Lute, Cyrus Agarabi, Sarah Johnson, Brittany Chavez, and Kurt Brorson (Abstract)

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Cost modeling of an integrated, continuous downstream mAb platform, Mark Schofield (Abstract and Presentation)

Facility design concepts for adoptive T-cell immunotherapy, Tania Pereira Chilima, Clive Glover, Fabien Moncaubeig, and Suzanne S. Farid (Abstract)

Continuous desalting of refolding solution by ion exchange chromatography, Nicole Walch and Alois Jungbauer (Abstract)

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Continuous gas processing without bubbles using thin liquid film bioreactors containing biocomposite biocatalysts, Michael C. Flickinger, Orlin D. Velev, Mark J. Schulte, Adam Wallace, Christopher Duran, Nilay Chakraborty, Michael Guarnieri, and Kamelia Boodhoo (Abstract and Presentation)

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Novel concepts for efficient and predictable membrane separation in continuous cell retention and downstream processing, Ulrich Kulozik, Martin Hartinger, and Maria Weinberger (Abstract and Presentation)

Stirred tanks in cascades and plug-flow tubular bioreactors for continuous production of viral vaccines, Felipe Tapia, Yvonne Genzel, Udo Reichl, and Volker Sandig (Abstract)

Scalable lentiviral vector production using stable producer cell lines in perfusion mode, Aziza Manceur, Sven Ansorge, Stéphane Lanthier, Sonia Tremblay, July Dorion-Thibaudeau, Julia Transfiguracion, Hafida Aomari, and Rénald Gilbert (Abstract)