Final Program

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)