Integrated Continuous Biomanufacturing
Castelldefels, Spain
October 20-24, 2013
Sunday, October 20
Session 1
Continuous Processing: Learning from Related Industries
Session Chairs: Nigel Titchener-Hooker (University College London), Chetan Goudar (Amgen Inc.)
The amazing ability of continuous chromatography to adapt to a moving environment
Roger-Marc Nicoud, Founder of Novasep, Consultant
Semi-continuous manufacturing of personal care liquids
Peter Divone, Unilever
The Promise of Continuous Biomanufacturing – Keynote Lecture
Konstantin Konstantinov, Genzyme-Sanofi
Monday, October 21
Session 2
Upstream Processing
Session Chairs: Veronique Chotteau (Royal Institute of Technology), Gerben Zijlstra (DSM Biologics B.V.)
Desiccated cellular composites could enable modular continuous upstream biomanufacturing
Michael C. Flickinger, North Carolina State University
Continuous and semi-continuous cell culture for production of blood clotting factors
Sunil Desai, Pfizer
Upstream development of high cell density, perfusion processes for continuous manufacturing
Timothy Johnson, enzyme-Sanofi
Multiplicity of steady states in continuous culture of mammalian cells
Wei-Shou Hu, University of Minnesota
Case study: Challenges and learning in implementing ATF perfusion process
Jarno Robin, Novo Nordisk
Session 3
Downstream Processing
Session Chairs: Alois Jungbauer (University of Natural Resources and Life Sciences), Brian Hubbard (Amgen Inc.)
Twin column Capture SMB: A novel cyclic process to increase the capacity utilization in protein A chromatography
Massimo Morbidelli, ETH Zurich
Continuous chromatography: Disruptive technology for downstream processing
Fabien Rousset, Novasep
A process for next generation antibody production: Cold ethanol precipitation and calcium-phosphate flocculation of recombinant antibodies
Nikolaus Hammerschmidt, University of Natural Resources and Life Sciences Vienna
Continuous antibody capture with protein A countercurrent tangential chromatography: A new column-free approach for antibody purification
Andrew Zydney, Pennsylvania State University
Nanofibres for high productivity downstream processing
Oliver Hardick, Puridify
A new, integrated, continuous purification process template for monoclonal antibodies
Alex Xenopolos, EMD Millipore
Workshop 1: Addressing the Process & Economic Dimensions of ICB
Workshop Chairs: Suzanne Farid (University College London), Andrew Sinclair (BioPharm Services)
Fully automated end-to-end continuous manufacturing of small molecule pharmaceuticals and implications for biologics – Keynote Lecture – Bernhardt Trout, Massachusetts Institute of Technology
Poster Viewing Poster Chairs: Richard Biener (University of Applied Sciences, Esslingen), James Michaels (BioMarin)
Tuesday, October 22
Session 4
Case Studies of Integrated Continuous Processing in Practice
Session Chairs: Bernhard Helk (Novartis Pharma AG), Veena Warikoo (Genzyme-Sanofi), Jens Vogel (Boehringer Ingelheim)
Integrated and scalable cyto-technology (InSCyT) platform for biopharmaceutical manufacturing on demand
Chris Love, Massachusetts Institute of Technology
Single-use systems supporting continuous biomanufacturing for current and “next-gen” products
William Whitford, Thermo Fisher Scientific
New approaches in continuous biomanufacturing: Continuous XD® cell cultures (At 100 million cells/mL and beyond) coupled to the Rhobust® EBA integrated clarification and purification technology
Gerben Zijlstra, DSM Biologics B.V
Platform downstream processes in the age of continuous chromatography: A case study
Mark Brower, Merck & Co.
End-to-end continuous production of complex recombinant proteins, integration of perfusion cultivation and automated multi-step purification
Peter Tiainen, Novo Nordisk A/S
How to purify a monoclonal antibody in one shot: Continuous chromatography applied to the entire purification process
Laure Landric-Burtin, Sanofi
Continuous processing in biotech production as an alternative to a modern batch, single-use facility
Thomas Daszkowski, Bayer Technology Services
Biologicals for global health: The case for lower cost drugs – Keynote Lecture
Stephen Hadley, Bill and Melinda Gates Foundation
Session 5
PAT, Process Modeling, Monitoring and Control
Session Chairs: Thomas Scheper (University of Hannover), Reinhard Baumfalk (Sartorius Weighing Technology GmbH)
PAT for real time monitoring and control of continuous drug manufacturing process: Lessons learned
Peter McDonnell, Sanofi
Requirements for process control of continuous processes: sensorics and automation
Marek Hoehse, Sartorius Stedim Biotech GmbH
From design of experiments to closed loop control
Petter Moree, Umetrics
A label-free methodology for selective in-line quantification of co-eluting proteins in chromatography by means of spectral data
Nina Brestrich, Karlsruhe Institute of Technology
Session 6
Process Validation and Regulatory Considerations
Session Chairs: Chantal Cazeault (Amgen Inc.), Mark Heintzelman (Genzyme-Sanofi)
Integrated continuous biomanufacturing: Quality and regulatory considerations
Chantal Cazeault, Amgen Inc.
A quality perspective on continuous biomanufacturing
Frank Lammers, Sanofi
Tecnological, regulatory, and validation considerations for single-use downstream processing
Marc Bisschops, Tarpon Biosystems Europe B.V.
A regulatory perspective on continuous perfusion production of rFVIII
Robert W. Kozak, Bayer HealthCare LLC
Wednesday, October 23
Session 7
Clinical and Commercial Facility Design for Continuous Biomanufacturing
Session Chairs: Thomas Daszkowski (Bayer AG), Marc Pelletier (CRB)
Operational and economic evaluation of integrated continuous biomanufacturing strategies for clinical and commercial antibody production
Suzanne S. Farid, University College London
Implementing process closure and continuous processing into the modern biopharmaceutical future facility
Marc Pelletier, CRB
Data management and control strategies for continuous bioproduction
Kjell Francois, Siemens AG
Facility drivers for housing start-to-finish continuous bioprocessing: Disruptive changes in scale and operational expectations vs. traditional batch operations
Bradley E. Kosiba, BK Collaborative, LLC
Building a business case for fully integrated continuous biomanufacturing platform
Jason Walther, Genzyme-Sanofi
Session 8
Continuous Processing in Vaccine Manufacturing, Stem Cells, and Microbial Cultures
Session Chairs: James Piret (University of British Columbia), Jean-Marc Guillaume (Sanofi-Pasteur)
Options for continuous production of cell culture-derived viral vaccines
Udo Reichl, Max Planck Institute for Dynamics of Complex Technical Systems
Sequential/parallel production of potential Malaria vaccines – a fast way from single batch to quasi continuous production
Reiner Luttmann, Hamburg University of Applied Sciences
Bioengineering approaches for up- and down- stream processing of human stem cells for clinical application
Margarida Serra, ITQB-UNL/iBET
Optimization of T cell expansion in a perfusion bioreactor
Clive Glover, GE Healthcare UK Limited
Matching Flows: The development of continuous bioprocessing, new initiatives in the approval of bioproducts, and assurance of product quality throughout the product lifecycle – Keynote Lecture
Jeffrey Baker, FDA
Workshop 2: New Modalities, Enabling Technologies and Unit Operations
Workshop Chairs: Uwe Gottschalk (Sartorius-Stedim Biotech), Karol Lacki (GE HealthCare)