October 6-10, 2019
Ocean Edge Resort
Brewster (Cape Cod), Massachusetts, USA

Editors:   Veena Warikoo, Roche, USA
  Alois Jungbauer, BOKU, Austria
  Jon Coffman, Boehringer Ingelheim, USA
  Jason Walther, Sanofi, USA

The articles for these proceedings are not peer-reviewed.



Conference Program, Veena Warikoo, Alois Jungbauer, Jon Coffman, and Jason Walther (Article)

Advanced manufacturing of complex biologics: A CBER perspective, Manuel Osorio (Abstract)


Workshop: Regulatory Gaps in Continuous Processing, Andrew Sinclair and Karen Sitney (Abstract and Presentation)

Workshop: High-throughput Methodologies for ICB, Marcel Ottens and Rohan Patill (Abstract)

Pushing the closed and continuous boundary: End-to-end ICB at the pilot scale, Kevin Brower, Michael Coolbaugh, Tarl Vetter, Marcus Fiadeiro, Brad Bouchard, Nihal Tugcu, Emily Davenport, and Chad Varner (Abstract)

Performance evaluation of an automated and continuous antibody purification process in a side-by-side comparability study, Benjamin Maiser, Klaus Kaiser, Martin Lobedann, and Laura David (Abstract)

Implementing connected processes at-scale - Challenges and opportunities for streamlining operations, Mark Brower, Nuno Pinto, Gregg Nyberg, Eva Gefroh, Rob Piper, and Tim Wanek (Abstract)

Integrated continuous bioprocessing: Costs of goods versus cost of development, Hanna Mahal, Christos Stamatis, and Suzanne S. Farid (Abstract)

iSKID: From integrated pilot scale runs to GMP implementation approach, Raquel Orozco, Scott Godfrey, Joelle Koury, Aaron Kwong, Charles Capron, Zack Kyser, Matt Brown, Eike Zimmerman, Daisie Ogawa, Jon Coffman, Jeff Salm, Mike Jankowski, Robert Kottmeier, Matt Stork, and Rob Fahrner (Abstract)

Development and future manufacturing of live biologicals, John Aunins (Abstract)

The next generation of therapeutics face dramatic challenges – is ICB an answer?, Joseph Shultz (Abstract)

Complex new modalities require advanced bio manufacturing platforms: The case of exosome biotherapeutics, Konstantin Konstantinov (Abstract)

Design of a periodic counter-current chromatography process for efficient oncolytic virus purification, Ricardo Silva, João Mendes, Mikael Berg, Linda Mathiasson, Manuel J.T. Carrondo, Paula M. Alves, Tecnologia Química e Biológica António Xavier, and Cristina Peixoto (Abstract)

Continuous mode of production for two classes of defective interfering influenza A virus particles as antiviral candidates, Marc Hein, Felipe Tapia, Yvonne Genzel, Sascha Young Kupke, and Udo Reichl (Abstract)

Towards continuous bioprocessing of lentiviral vectors, Sven Ansorge, Maurizio Cattaneo, Anja Rodenbrock, July Dorion-Thibaudeau, Sonia Tremblay, Aziza Manceur, Louis-Patrick Gagnon, Krishna Raj Tiwari, Rénald Gilbert, and Stéphane Lanthier (Abstract)

The new manufacturing paradigm: Challenges and opportunities of integrated continuous bioprocessing, Matt Shields (Abstract)

GMP implementation of connected and continuous process at Amgen, Art Hewig (Abstract)

Continuous bioprocessing with Ultra-high productivity to expedite biologics development, Weichang Zhou (Abstract)

Developing a flexible automated continuous downstream processing system for research to clinical supply, Louise Taylor, Harvey Branton, Daniele Messina, John Welsh, Spyridon Gerontas, Martyn Hulley, Richard Krucia-Tran, Tibor Nagy FujiFilm, and Ferran Sanchez (Abstract)

GMP design of a single-use integrated continuous bio manufacturing system, Robert E. Kottmeier, Rob Fahrner, Scott Godfrey, Greg Hiller, Phil McCormick, Raquel Orozco, and Jeff Salm (Abstract)

Application of continuous processing in cell and gene therapy: Current state and future opportunities, Susan Abu-Absi, Lesley Chan, and Ken Kotz (Abstract)

Leveraging development to advance digital and PAT technologies in manufacturing, Rick St. John (Abstract)


Control strategies for integrated continuous bioprocessing, Christoph Herwig (Abstract and Presentation)

Digital transformation in bio manufacturing, Amos E. Lu and Richard Braatz (Abstract)

Development of scalable semi-continuous downstream processes, Xuankuo Xu, James Angelo, Daniel Baur, Srinivas Chollangi, Thomas Müller-Späth, Weixin Jin, Zizhuo Xing, Chao Huang, Jie Chen, Michael Borys, Massimo Morbidelli, and Sanchayita Ghose (Abstract)

Process validation approaches to continuous/connected downstream process, Huanchun Cui, Mathias Goebel, Rui Claudio Dos Reis Rodrigues, and Joseph Shultz (Abstract)

Continuous virus inactivation using a packed-bed reactor, Duarte L. Martins, Nikolaus Hammerschmidt, Björn Tille, Johanna Kindermann, Thomas R. Kreil, and Alois Jungbauer (Abstract)

Continuous viral inactivation: Understanding fundamental mass transfer enables simplified virus validation, Matthew Brown (Abstract)

Viral clearance validation for a fully continuous manufacturing process for phase 1 studies, Maarten Pennings and Ard Tijsterman (Abstract)

Strategy for targeted delivery of key nutrients in high cell density perfusion, Veronique Chotteau, Hubert Schwarz, Liang Zhang, Ye Zhang, Caijuan Zhan, Matthew Cheeks, Richard Turner, Andreas Castan, and Francisco Vilaplana (Abstract)

Process characterization for dynamic design space development: An intensified design of experiment method, Rui Manuel Freitas Oliveira (Abstract)

High density perfused batch: Robustness and scalability of perfusion processes from lab scale to commercial scale, David Garcia, Ying Jing, Joerg Altekrueger, and Joseph Shultz (Abstract)

Successful scale up of an intensified perfusion process to clinical and commercial scales, Charles Budde, Daryl Powers, Jeff Swana, and Jean McLarty (Abstract)

Tailor-made aqueous two-phase systems for application in continuous separation of potent biomolecules, Christoph Brandenbusch, Maximilian Wessner, Fabian Görzgen, Bettina Bommarius, Andreas Bommarius, and Gerhard Schembecker (Abstract)


Workshop 3: Business Cases for Integrated and Continuous Biomanufacturing, Jessica Molek and Daisie Ogawa (Abstract and Presentation)

Workshop 4: Big Data Analytics for Continuous Manufacturing, Christian Airiau, Christoph Herwig, and Joseph Horwitz (Abstract)

Automated continuous integrated manufacturing of monoclonal antibodies, Massimo Morbidelli (Abstract)

Exploring metabolic demands of high density CHO-cell cultures, Matthias Noebel, Verónica S. Martínez, Stephen Mahler, Cristiana Dal’Molin, and Esteban Marcellin (Abstract)

Modeling the residence time distribution of an end to end integrated biomanufacturing process, Jure Senčar and Alois Jungbauer (Abstract)


Experimental design and small-scale model for high-performing perfusion media and processes scalable to 50 L bioreactors, Andreas Castan, Patrick M ayrhofer, and Renate Kunert (Abstract and Presentation)

Elution profile from periodic counter current capture step as an on-line monitoring and control tool for perfusion bioreactors, Daniel Komuczki, Peter Satzer, Gerald Striedner, and Alois Jungbauer (Abstract)

Straight-through process development of up and downstream integration of monoclonal antibodies production using flocculation, AEX and one pass TFF, Rimenys J. Carvalho (Abstract)


Hydrocyclones for single-use perfusion application, Ioná W. Bettinardi, Andreas Castan, Ricardo A. Medronho, and Leda R. Castilho (Abstract and Presentation)

Flow-through chromatography as a continuous and integrated purification method, Shuichi Yamamoto, Chyi-Shin Chen, and Noriko Yoshimoto (Abstract)

Development of integrated continuous bioprocessing using Continuous Countercurrent Tangential Chromatography (CCTC) platform for capture and polishing of monoclonal antibodies, Oleg Shinkazh, Andrew Zydney, Bayard D. Kunkle, and Dmitriy Fedorenko (Abstract)

Intensifying the manufacture of hiPSC therapy products through metabolic and process understanding, Margarida Serra, Pedro Vicente, Catarina Gomes, Joana Almeida, Daniel AM Pais, Bernardo Abecasis, Marta Paiva, Inês A Isidro, Paula M Alves, Rebeca Mertinez-Turrillas, Juan R. Rodriguez-Madoz, Anders Aspegren, and Ibrahim Domian (Abstract)

Inclined plate settlers with novel receiver section as a unit operation for complex continuous solid-liquid separation problems, Hannah Engelmaier, Nikolaus Hammerschmidt, Christoph Dattenboeck, and Alois Jungbauer (Abstract)

Perfusion microbioreactor with integrated cell retention device, Amer Al-Lozi and Delia Lyons (Abstract)

Decreasing drug development timeline via upstream process intensification, Daisie Ogawa (Abstract)

Virus reduction filtration in continuous bioprocessing: Critical flux concept for virus breakthrough, Dharmesh Kanani, Mi Jin, Rong Fan, Fu Namila, Ranil Wickramasinghe, and Xianghong Qian (Abstract)

Novel periodic alternating tangential filtration harvest approach provides incresed volumetric productivity, Sean Cole, Johanna Mullen, Chetan Goudar, and Natalia Gomez (Abstract)

Manipulations of antibody galactosylation in a fed-batch adapted perfusion process, Mao-shih Liang, Namratha Kuloor, Jessica Kurth, Bryon Martinez, Amlan Das, Sourav Kundu, and Mi Jin (Abstract)

Development of scale-down models for validation of integrated continuous virus filtrations, Julie Kozaili, Scott Lute, Sarah Johnson, and Daniel Strauss (Abstract)

Continuous integrated biologics manufacturing, John Welsh, Louise Taylor, Daniele Messina, Spyridon Gerontas, Martyn Hulley, Richard Krucia-Tran, Tibor Nagy FujiFilm, and Ferran Sanchez (Abstract)

Perfusion process for the production of a new, VLP-based yellow fever vaccine candidate, Renata G. F. Alvim, Túlio M. Lima, and Leda R. . Castilho (Abstract)

Critical quality attributes (CQAs) of a therapeutic antibody produced from integrated continuous bioprocessing, I-Fen Liu, Ho-Lung Jiang, Wei-Kuang Chi, Ching-Jen Yang, Shih-Lung Hsu, and Ming-Yen Hsu (Abstract)

Process simulation based decisional tool to evaluate strategies for continuous downstream bioprocess implementation - A CDMO perspective, Kristina R. Pleitt, Balaji Somasundaram, Bradley Johnson, Evan Shave, and Linda H.L. Lua (Abstract)

High cell density optimization strategies for continuous bioprocesses using perfusion bioreactors, Jana Mahadevan and Delia Lyons (Abstract)


Continuous process performance enhancements for 50 L to 500 L single-use bioreactors: A technical comparison of erformance characterization, cell culture, and scale-up modeling, Tony Hsiao, Nephi Jones, and Jordan Cobia (Abstract and Presentation)

Apply adsorption technology to solve the UV sensor instability of dynamic control on periodic counter current purification system, Wei-Kuang Chi, I-Fen Liu, and Ho-Lung Jiang (Abstract)

Acoustic Wave Separation – A non-filtration approach for continuous clarification of perfusion cell culture prior to capture chromatography, Peter Levison, Andrew Elliott, Ing-Kae Wang, and Michael Collins (Abstract)


Production of Zika virus-like particles (VLPs) by perfusion processes, Renata G. F. Alvim and Leda R. Castilho (Abstract and Presentation)

Integration of upstream and downstream for a hybrid continuous process development and manufacturing for a stable monoclonal antibody produced in CHO cell culture, Jianlin Xu, Chao Huang, Xuankuo Xu, Christopher Oliveira, Mengmeng Xu, Charles Hill, Joon Chong Yee, James Angelo, Sanchayita Ghose, and Michael Borys (Abstract)

Conversion of biomanufacturing processes from fed-batch into integrated continuous: Strategy, methods and case studies, Ying Jing, David Garcia, Joseph Shultz, and Nuno Carinhas (Abstract)

Continuous downstream process development following quality by design philosophy, Marc Bisschops and Denis Kole (Abstract)

Evaluation of ambr® 250 perfusion bioreactor system as a model for high-throughput perfusion cell culture process development, Jack Huang, William Napoli, Matt Manahan, Barney Zoro, Jennifer Pollard, Sen Xu, and Jack Huang (Abstract)

Upstream process intensification using frozen high cell density intermediates, Luis Fernando Ayala Solares, Christian Schultheiss, Mona Bausch, Doris Matheis, Jana Glawion, Melanie Feigenspan, Caroline Ströder, and Jochen B. Sieck (Abstract)

Validation aspects in the commercialization of integrated continuous biomanufacturing, Canghai Lu (Abstract)

Direct inoculation of a perfusion bioreactor with a frozen intermediate seed train, Sofie Goetschalckx, Kathleen Barrette, Lada laenen, and Jiayi Zhang (Abstract)

A Virus Harvest Unit for the continuous harvesting of lentivirus from suspension cell cultures, Maurizio Cattaneo and Sven Ansorge (Abstract)

Definition of a platform continuous capture scale down model and link to scale-up for monoclonal antibody clinical manufacturing, Rebecca A. Chmielowski, Matt Kessler, Collette Cutler, Hong Li, and David Roush (Abstract)


Optimization study on periodic counter-current chromatography (PCC) integrated in a mAb downstream process, Joaquin Gomis Fons, Niklas Andersson, and Bernt Nilsson (Abstract and Presentation)

Flow-velocity programmed chromatography as an alternative method for increasing the efficiency of continuous- or integrated-chromatography processes, Chyi-Shin Chen, Noriko Yoshimoto, and Shuichi Yamamoto (Abstract)

Continuous aqueous two-phase system extraction using oscillatory flow reactor, Diogo Faria, Ana Azevedo, Raquel Aires Barros, and António Ferreira (Abstract)

Analytical and data strategy for continuous downstream manufacturing, Mehdi Ghodbane, Sobhana Sripada, Sayantan Bose, Patrick Pohlhaus, Jessica Molek, and Rajan Bhawnani (Abstract)

Accelerated process development for integrated end-to-end biologics manufacturing, Laura E. Crowell, Kerry Love, Steven Cramer, and J. Christopher Love (Abstract)

The NevoLineTM manufacturing system: Intensification & integration of upstream and downstream processing in a low-footprint, automated platform for viral production, Tania Pereira Chilima, Andy Reniers, Stéphanie Dubois, Tania Pereira Chilima, and José Castillo (Abstract)

Integration of XCellTM ATF perfusion with single column capture chromatography for production of monoclonal antibodies, Amit Dutta, Minghui Gui, and James Peyser (Abstract)

Model-based evaluation and process development of continuous chromatography, Dong-Qiang Lin, Ce Shi, and Shan-Jing Yao (Abstract)

Developing new perfusion capabilities for ambr(R) micro and mini bioreactors, Barney Zoro, Asma Ahmad, Alison Rees-Manley, James Edwards, Ellen Lam, and Ryan Cassidy (Abstract)

Leveraging Sanofi intensified ICB platform to enable early process development for a labile and hard-to-express molecule, Jiuyi Lu, Daryl Powers, Nathan Ostberg, Emily Davenport, Jason Walther, Kevin Brower, and Jean McLarty (Abstract)

Development of scale down models for perfusion bioreactor medium optimization, Meghan E. Casey, Jaimie Mastrogiacomo, Amy Johnson, Shawn Lawrence, Michelle LaFond, Hanne Bak, and Ashley Witmer (Abstract)

Introduction of intensified processes into the clinical supply center, Constanze Duerr, Gero Lipok, Alexander Herrmann, and Reinhard Braaz (Abstract)

Development of an N-1 perfusion medium to intensify seed train operation, Luis Fernando Ayala Solares, Caroline Ströder, Christian Schultheiss, Jana Glawion, Melanie Feigenspan, Jochen B. Sieck, and Luis Fernando Ayala Solares (Abstract)

A CDMO perspective toward the implementation of continuous bioprocessing stand- alone and integrated offerings, Claudia Berdugo-Davis, Kevin Humbard, Ben Kester, Emily Schirmer, Brian Follstad, Ian Collins, Li Yunsong, Victor Vinci, and William Wessel (Abstract)

Small-scale end-to-end mAb platform with a continuous and integrated design, Hubert Schwarz, Hubert Schwarz, Liang Zhang, Niklas Andersson, Bernt Nilsson, and Veronique Chotteau (Abstract)

Novel amino acid feeding strategy in perfusion cultures to enhance monoclonal antibody production, Hubert Schwarz and Veronique Chotteau (Abstract)

Continuous antibody capture step based on Magnetic Beads, Nils Arnold Brechmann, Joaquin Gomis Fons, Kristofer Eriksson, Sven Oscarsson, Atefeh Shokri, Bernt Nilsson, and Véronique Chotteau (Abstract)

Implementation of an integrated continuous downstream process for a monoclonal antibody production, Wei (Heidi) Gong, Ran Chen, Bin Yao, Xujun Chen, Biao Jiao, and Wei Wang (Abstract)