November 1-5, 2015 - Claremont Hotel Club & Spa, Berkeley, California, USA
| Editors: | Chetan Goudar, Amgen Inc. |
|---|---|
| Suzanne Farid, University College London | |
| Christopher Hwang, Genzyme-Sanofi | |
| Karol Lacki, Novo Nordisk |
The articles for these proceedings are not peer-reviewed.
Final Program, Kathy Chan (Conference Proceeding)
Delivering steady-state product quality with an intensified and integrated perfusion cell culture process, Jason Walther, Neha Shah, Myles Hollenbach, Jonathan Wang, Marcela Yu, Jiuyi Lu, Konstantin Konstantinoc, and Chris Hwang (Conference Proceeding)
Exometabolome characterization of high cell density culture perfusion and optimization of the cell specific perfusion rate, Veronique Chotteau, Leila Zamani, Ye Zhang, Magnus Aberg, Anna Lindahl, and Axel Mie (Conference Proceeding)
Development of a first generation perfusion process and medium for continuous processing based on existing fed-batch platform media, Henry Lin, Samantha Wang, Robert Leighty, Scott Godfrey, Samet Yildirim, Adam Osborne, Flaka Radonigi, Jens Vogel, and Jon Coffman (Conference Proceeding)
Medium optimization case study for continuous upstream process, Rashmi Kshirsagar and Alan Gilbert (Conference Proceeding)
Upstream perfusion process: Back to the future, Jean-Marc Bielser, Henri Kornmann, and Herve Broly (Conference Proceeding)
Integration of continuous ethanol precipitation and flocculation into manufacturing of antibodies, Alois Jungbauer, Nikolaus Hammerschimidt, and Peter Satzer (Conference Proceeding)
Towards continuous aqueous two-phase extraction (CATPE), Bettina Bommarius, Andres Bommarius, Irene Kaplanow, Julianne Merz, and Gerhard Schembecker (Conference Proceeding)
Considerations for an incubation chamber for continuous viral inactivation, Raquel Orozco, Nancy Guillen, Loleta Chung, Scott Godfrey, and Jon Coffman (Conference Proceeding)
Robust design and operation of quasi-continuous adenovirus purification by two-column, simulated moving-bed, size-exclusion chromatography, Jose Mota, Ricardo Silva, Piergiuseppe Nestolla, Cristina Peixoto, and Manuel Carrondo (Conference Proceeding)
Continuous downstream process or connected batch process: Which one makes most sense for Biogen?, John Pieracci, Sanchayita Ghose, and Venkatesh Natarajan (Conference Proceeding)
What is holding the industry back from implementing CBP (Continuous Bioprocessing) more broadly?, Morten Munk (Conference Proceeding)
Evaluating facility design and capacity planning decisions for clinical and commercial supply with hybrid continuous processes, Suzanne Farid (Conference Proceeding)
What are the facility design requirements to fit biologics pipeline demands?, Thomas Sauer (Conference Proceeding)
A biomanufacturing facility based on continuous processing and single use technology, Jorgen Magnus, Maike Temming, Peter Schwan, Jovana Micovic, Martin Lobedam, and Stefan Sievers (Conference Proceeding)
Impact of closed and continuous processing on biopharmaceutical facility layouts, Marc Pelletier (Conference Proceeding)
Innovations in bioreactor operational modes – Hybrid semi-continuous processes to push beyond the limits of conventional fed-batch cultures, Gregory Hiller, Matthew Gagnon, Ana Maria Ovalle, Wenge Wang, and Elizabeth Eydelman (Conference Proceeding)
Development of functionally closed downstream operations for continuous biomanufacturing of recombinant therapeutic proteins, Rohan Patil, Rahul Godawat, Tarl Vetter, Yogesh Waghmare, Konstantin Konstantinov, and Veena Warikoo (Conference Proceeding)
Integrated continuous bioprocessing – opportunities and challenges, Mats Akesson, Martin Heitmann, Ditte Skipstrup, and Peter Tiainen (Conference Proceeding)
Design and control of chromatography step in an integrated column sequence, Bernt Nilsson, Niklas Andersson, Anders Holmqvist, Anton Sellberg, Peter Tiainen, and Arne Staby (Conference Proceeding)
Integrated continuous processing for the manufacture of monoclonal antibodies, Daniel Karst, Fabian Steinenbach, and Massimo Morbidelli (Conference Proceeding)
Continuous culture and downstream processing of algae with recycle: An integrated large-scale approach for production of renewable crude oil, Matt Croughan (Conference Proceeding)
Continuous beer production methods: A review of chances and risks, Konrad Müller-Auffermann (Conference Proceeding)
Monitoring and control of reproducibility in quasi-continuous integrated production processes of Active Pharmaceutical Ingredients, Reiner Luttman, Sven Oliver Borchert, Jan Patrick Voss, and Gesine Cornelissen (Conference Proceeding)
Protein Refinery Operations Lab (PRO Lab): A sandbox for continuous protein production & advanced process control, Mark Brower, David Pollard, and Finn Hung (Conference Proceeding)
The use of dynamic control in periodic counter current chromatography, Hans Blom and Helena Skoglar (Conference Proceeding)
Leveraging large data sets in continuous chromatography applications: Monitoring critical process parameters using MVDA, Engin Ayturk (Conference Proceeding)
PAT concepts for chromatography: Real-time monitoring, real-time control, and cause of error diagnostics, Nina Brestrich, Tobias Hahn, Adrian Sanden, Till Briskot, and Jurgen Hubbuch (Conference Proceeding)
Dynamic oncolytic measles virus production, Tanja Grein, Denise Salzig, Michael Muehlebach, and Peter Czermak (Conference Proceeding)
How continuous-like processes improve affordability for viral vaccines - Example of LAIV, Jose Castillo (Conference Proceeding)
Small-scale platform for rapid on-demand manufacturing of recombinant proteins, J. Christopher Love (Conference Proceeding)
Exploring continuous and integrated strategies for the up- and downstream processing of human mesenchymal stem cells, Barbara Cunha, Tiago Aguiar, Ricardo Silva, Cristina Peixoto, Manuel Carrondo, Margarida Serra, and Paula Alves (Conference Proceeding)
CDER's emerging technology team, Kurt Brorson and Sau Lee (Conference Proceeding)
Quality systems for continuous manufacturing, Ron Branning (Conference Proceeding)
Regulatory challenges of continuous biomanufacturing, Andy Papas (Conference Proceeding)
A regulatory perspective on continuous perfusion production of rFVIII, Robert Kozak (Conference Proceeding)
Transforming the present into the future with uncertainty and imprecision, Chales Cooney (Conference Proceeding)
Spectral deconvolution of chromatograms without offline analytics, Matthias Rudt, Nina Brestrich, Florian Dismer, and Jurgen Hubbuch (Conference Proceeding)
PAT concepts for the process monitoring and control of continuous biomanufacturing, Eike Zimmerman, Jeff Goby, and Anoushka Durve (Conference Proceeding)
Inline spiking for viral clearance validation of continuous processes, Herb Lutz (Conference Proceeding)
Advanced computational tools to enhance continuous monoclonal antibody production, Maria M. Papathanasiou, Ana Quiroga, Athanasios Mantalaris, and Efstratios Pistikopoulos (Conference Proceeding)
Optical enzymatic sensors for continuous monitoring of bioreactors, Kenneth Reardon, Brian Heinze, and Trenton Danna (Conference Proceeding)
Optimal control of a continuous bioreactor for maximized beta-carotene production, Nazmul Karim, Jonathan Raftery, and Xinghua Pan (Conference Proceeding)
Strategy for scaling semi-continuous downstream and integration of process analytical tools for monoclonal antibody toxicology, Darshini Shah, Rebecca Chmielowski, Colette Cutler, Hong Li, David Roush, and Nihal Tugcu (Conference Proceeding)
Continuous production of proteins: Integration of polishing using MCSGP, Fabian Steinebach, Daniel Karst, and Massimo Morbidelli (Conference Proceeding)
Process time and cost savings achieved through automation and islands of integration in existing facilities., Rob Noel, Yuki Abe, Andrew Sinclair, and Lynne Frick (Conference Proceeding)
Tools for process intensification upstream and continuous processing downstream, James Rusche (Conference Proceeding)
Integrated solutions for continuous processing in Mobius® bioreactor systems, Andrew Clutterbuck (Conference Proceeding)
Laboratory scale continuous linear purification as a development tool for recombinant blood protein processing, using chromatographic resins and membranes, MIchael Hughson, Rimenys Carvalho, Thaynna Araujo Cruz, and Leda dos Reis Castilho (Conference Proceeding)
Integrated and single use continuous manufacturing, Atul Mohindra (Conference Proceeding)
Enabling technologies for integrated / continuous downstream processing of biologics, Jeff Salm, Marcus Fiadeiro, Raquel Orozco, Jill Kublbeck, Aaron Noyes, Jeff Horne, Daniel LaCasse, Ashley Sacramo, Suhani Gupta, John Coffman, and Robert Fahrner (Conference Proceeding)
Design criteria and requirements for development of perfusion media, Jochen Sieck (Conference Proceeding)
GlycoExpress: A toolbox for the high yield production of glycooptimized fully human biopharmaceuticals in perfusion bioreactors at different scales, Steffen Kreye (Conference Proceeding)
Novel compact cell settlers for continuous perfusion bioreactor cultures of microbial (and mammalian) cells, Dhinakar Kompala and Brian Batt (Conference Proceeding)
Continuous countercurrent tangential chromatography for purification of high value therapeutic proteins, Andrew Zydney, Oleg Shinkazh, Boris Napadensky, and Amit Dutta (Conference Proceeding)
Factors affecting the productivity of 4-Column Periodic Counter Current Chromatography (4C-PCC), Hani El-Sabbahy, Laura Fagan, and Verity Nancollis (Conference Proceeding)
Monitoring intracellular component pools to identify steady state in mammalian cell perfusion culture, Daniel Karst, Robert Steinhoff, Marie Kopp, Renato Zenobi, Massimo Morbidelli, and Miroslav Soos (Conference Proceeding)
Simple method transfer from batch to continuous chromatography process to fit parameters to business needs, Rene Gantier, Karl Rogler, Xhorxhi Gjoka, Ron Noel, Alexander Martino, and Mark Schofield (Conference Proceeding)
EcoPrime twin – Scale-up of CaptureSMB to the process scale, Kathleen Mihlbachler, Thomas Muller-Spath, Lars Auman, Michael Bavand, Rick Langone, and Gerard Gach (Conference Proceeding)
A novel plant cell culture platform for semicontinous production of recombinant proteins: Butyrylcholinesterase as a case study, Jasmine Corbin, Bryce Hashimoto, Kalimuthu Karuppanan, Raymond Rodriguez, Somen Nandi, Brian Roberts, Amy Noe, and Karen McDonald (Conference Proceeding)
Case study: Optimisation of a stabilised large scale atf perfusion process, Jarno Robin (Conference Proceeding)
Evaluation of a continuous chromatography process through process modeling and resin characterization, Ketki Behere and Seongkyu Yoon (Conference Proceeding)
Comparison of bioreactor systems operated at high bacterial cell density for the production of lactic acid: Batch – CSTR – CSTR cascade – Tubular reactor, Ulrich Kulozik (Conference Proceeding)
Scale up and implementation of a high density long-term perfusion suspension cell culture in a 250L single use bioreactor, Weichang Zhou and Hang Zhou (Conference Proceeding)
BioSC® predict simulation software: FLexibility and optimization of your multi-column process, Fabien Rousset (Conference Proceeding)
Mathematical modeling of a bioreactor producing Epo-hr operating in perfusion mode, Osman Fernandez, Raydel Alvarez, Ernesto Chico, Adolfo Castillo, and Julio Dustet (Conference Proceeding)
Efficient approaches for perfusion medium development, Thomas Falkman, Andreas Castan, Eric Faldt, Teres Persson, Jill Simon, and Helena Nordvarg (Conference Proceeding)
Continuous production of viral vaccines with a two-stage bioreactor system, Felipe Tapia, Yvonee Genzel, Ingo Jordan, Volker Sandig, and Udo Reichl (Conference Proceeding)
Continuous downstream processing of a monoclonal antibody using Periodic Counter Current Chromatography (PCC) and Straight Through Processing (STP), Hans Blom, Christer Eriksson, Annika Forss, and Helena Skoglar (Conference Proceeding)
Bioprocess economics and optimization of continuous and pre-packed disposable chromatography, Richard Allmendinger and Suzanne Farid (Conference Proceeding)
Modeling perfusion at small scale using ambr15TM, Dustin Davis, Delia Lyons, and Scott Ross (Conference Proceeding)
Evaluation of novel CEX resin for continous processing of MAb purification, Takuya Muramoto, Satoshi Murakami, Shinsuke Higuchi, and Keiji Iwamoto (Conference Proceeding)
Designing a microbial cultivation platform for continuous biopharmaceutical production, Nicholas Mozdzierz, Kerry Love, Alan Stockdale, John Clark, Noelle Colant, and Christopher Love (Conference Proceeding)
Continuous purification of hepatitis C virus-like particles by multi-column chromatography, Ricardo Silva, Alex Xenopoulos, Jose Mota, Cristina Peixoto, Manuel Carrondo, and Paula Alves (Conference Proceeding)
BHK cells physiological response to spin-filter stress condition, Bruno Labate and Aldo Tonso (Conference Proceeding)
mAb product consistency achieved in long duration microfiltration-based CHO perfusion process, Douglas Rank, Christopher Martin, Lee Madrid, and Michael Phillips (Conference Proceeding)
Design of a continuous precipitation operation for protein capture, Todd Przybycien, Orlando Jaquez, and Robert Gronkel (Conference Proceeding)
Biopharmaceutical capacity planning for batch and semi-continuous bioprocesses under various strategic criteria, Cyrus Siganporia, Thomas Daszkowski, Andreas Schluk, Brijesh rao, Lazaros Papageorgiou, and Suzanne Farid (Conference Proceeding)
Salt-tolerant cation exchange HD-Sb hydrogel membrane: mAb purification performance in flowthrough mode, Dharmesh Kanani, Daniel Luo, Nirali Paghdal, Navneet Sidhu, Annabel Shang, and Jim Stout (Conference Proceeding)
Toward complete continuity in antibody biomanufacture: Multi-column continuous chromatography for Protein A capture and mixed mode hydroxyapatite polishing, Anthony Grabski, Tom Van Oosbree, Beth Hammer, Alla Zilberman, and Robert Mierendoff (Conference Proceeding)
Alternating flow filtration as an alternative to internal spin filter based perfusion process: Impact on productivity and product quality, Guillermina Forno, Cristian Paillet, Laura Mauro, Ignacio Amadeo, and Eduardo Orti (Conference Proceeding)
Pilot scale hybrid fed batch and continuous processing of biologics, Dave Sullivan, Michael O'Connor, Samir Gondalia, and Matt Gagnon (Conference Proceeding)
From fed-batch to perfusion: Productivity and quality considerations for a late-stage program, Sen Xu and Hao Chen (Conference Proceeding)
Continuous culture in the age of single-use, Christel Fenge and Melisa Carpio (Conference Proceeding)
Genomics based methodology of cell-culture media formulation for improved biotherapeutic productivity and quality consistency, Hemlata Bhatia and Seongkyu Yoon (Conference Proceeding)