Continuous Biomanufacturing: Current Success and Future Trends

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1 WORLD BIOPHARM FORUM 2017 Continuous Biomanufacturing: Current Success and Future Trends Lady Margaret Hall, University of Oxford, Oxford, UK 26th-28th June,

2 A WARM INVITATION TO COME AND JOIN US IN OXFORD I invite you to join us at the fourth international conference on Continuous Biomanufacturing: Current Success and Future Trends which will be held at Lady Margaret Hall, University of Oxford, Oxford, UK on June 26-28, With the continuous advancement of technologies and developments the adaption of Continuous Biomanufacturing in Biotech Industries seems challenging and intriguing. The Biotech industries are at present in the initial stage of a new technology adaptation cycle. Even though the benefits from Continuous Biomanufacturing are already well documented they are yet to establish its true meaning. Various technologies are continuously emerging both in upstream and downstream processing, the future trends should focus on proven technologies on integration of multiple unit operations into a single process, thus optimising the entire biomanufacturing systems as a whole. The conference is enhanced by participation of several leading industrial scientists, technologists and also academics from Europe, USA and Asia. They have come forward to share their experiences and knowledge not only to provide a better understanding of the current success but to project the future trends that are needed to fulfil its true definition. Sponsored by By joining us at Oxford we will together drive change, innovate growth and pioneer smart technologies to ensure they reach its complete potential. I look forward to welcoming you at Lady Margaret Hall with its beautiful surrounding in the city of Oxford. G.Subramanian * MONDAY 26TH JUNE Registration Introduction Dr G Subramanian Strategies and Theory in CB Chairman: Miriam Monge Strategies and points to consider for Continuous Biomanufacturing Dr Parrish Galliher, Chief Technology Officer, GE Healthcare, USA. 1.30pm Process design and engineering challenges for continuous biomanufacturing Professor Jochen Strube, Director, Institute for separation technology, T.U.Clausthal, Germany 2.00pm Chromatography Solutions for Integrated Continuous Bioprocessing Dr Dana Pentia, Senior Application Scientist RepliGen BioProcessing, USA. 2.30pm Developments in countercurrent protein polishing: theory and experiments Professor Ajoy Velayudhan, Department of Biochemical Engineering, University College of London, UK. 3.00pm Round-table discussion: on optimisation and control of SMB for proteins. Chairman: Professor Ajoy Velaudhan 3.30pm Process and control Engineering Chairman Dr Paarish Galliher 4.15pm Integrated control and monitoring of continuous biomanufacturing Professor Richard Baartz, MIT, USA 4.45pm Multi-Parametric Control Strategies for Enabling Continuous Biomanufacturing Professor Christoph Herwig, Institute of Chemical Engineering, VUT, Vienna, Austria 5.15pm Process Intensification: Increased efficiency through coupling single-pass TFF to chromatography Dr Mathilde Bourguignat, Merckgroup, Strasbourg, France. 5.45pm The latest developments in process intensification and integration Dr Gerben Zijlstra, Sartorius-Stedim Biotech, France. TUESDAY 27TH JUNE Materials, Design and Equipment Engineering Chairman Professor Jochen Strube 8.00am Being spoiled for choice: single-use or stainless steel and how to perform proper scale-up Dr Stefen Whieschaka, Rentschler Biotechnologie GmbH, Germany. 8.30am Process intensification strategies by Novasep Dr Thomas Flouquet, Group Novasep, France. * The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada.

3 9.00am Impact of facility design and operation (operating model) when mounting into CM Dr Morten Munk, Global Technology Partner, NNEpharmaplan, Denmark. 9.30am Panel discussion Roadblocks to implementation of CB and how to remove them. Chairman, Dr Joanne Beck, EVP Global pharmaceutical development and operation, Celgene, USA. Panel TBA am Networking and refreshments Emerging Applications, and Regulation Chairman Andrew Clutterbuck 10.30am Continuous manufacturing of extracellular vesicle reference materials Dr William Whitford, Strategic Solutions Leader Cell Culture, Bioprocess, GE Healthcare, USA 11.00am Integrated upstream and downstream process in protein manufacturing Professor Masimo Morbidelli and Nicole Ulmer, Institute of Chemical Engineering, Zurich, Switzerland 11.30am Continuous Chromatography and its role in process intensification Linda Matthiasson, GE Healthcare, Uppsala, Sweden Robust operation of Protein SMB Chris Wayne, Department of Biochemical Engineering, University College of London, UK 12.30pm Regulatory aspects of integrated continuous downstream processing: continuously making safe biotherapeutics and maintaining traceability Dr Marc Bisschops, Principal Scientist, Pall Lifesciences Lunch Continuous Cell Culture/ Perfusion Bioreactors Chairman Marc Bisschops 2.00pm Invited Lecture: Perspective of scale-down systems for high-cell density perfusion of mammalian cell culture Dr Veronique Chotteau, KTH, Royal Institute of Technology, Sweden 2.30pm Perfusion-based production of inoculum cultures for Large volume cell banks Ina Dittler, Institute of Chemistry and Biotechnology, Switzerland 3.00pm Plug-flow tubular and stirred tank for continuous vaccine production: virus stability and interference by defective particle Dr Filipe Tapia, Maxplank Institute Magdeburg, Germany. 3.30pm Accelerate Cell Culture Development Using the Modular Automated Sampling Technology (MASTTM) Platform Dr Clint Pepper, Director, MAST Products Capsugel BRIO: Corporate Pl. Bend OR, USA 4.00pm 4.30pm Single-use considerations for the high yield production of glyco-optimized biopharmaceuticals with human cells in perfusion bioreactors Dr. Rainer Stahn. Director Process Development, Glycotope GmbH, Germany 5.00pm Influence of cell culture medium on the economy of perfusion processing Delia Lyons, Sial, USA 5.30pm Application of perfusion in vaccine production using drosophila S2 insect cells Dr Wian de Jung, CSO, Expres2ion, Denmark. 6.00pm Continuous processing for vaccine manufacturing - challenges and opportunities by Yan-Ping YANG, PhD, Head BioProcessing R&D NA, Sanofi Pasteur, Toronto, Canada WEDNESDAY 28TH JUNE Monoclonal Antibody Processing Chairman Dr Yan-Ping Yang 9.00am Qualification and validation approach for phase 1 GMP continuous manufacturing of Mab Maarten Pennings, CTO, Biosanapharma, The Netherlands 9.30am Continuous countercurrent tangential chromatography for monoclonal antibody purification Professor Andrew Zydney, Department of Chemical Engineering, PSU, USA 10.00am Evolution of Mab processing: The opportunity represented by next generation processing Dr Chase Duclos Orsello, Global Marketing Head, MilliporeSigma, USA am 11.00am Optimising multi-column Protein A chromatography Dr Michael Rose, UCB, Slough, UK 11.30am Case Study: Comparing Cost of Manufacturing between Batch vs Continuous Manufacturing Process for Mabs. Priyanka Gupta global senior bioprocess modelling consultant, India Case Study: Large scale continuous purification of Mab: seamless scale-up from grams to kilograms Dr Marc Bisschops, Principal Scientist, Pall Lifesciences pm Concluding Remarks: Dr William Whitford, Strategic Solutions Leader Cell Culture and Bioprocess. GE Healthcare, USA. Lunch

COMING SOON This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous

Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream

The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.

Edited by Ganapathy Subramanian Continuous Biomanufacturing Innovative Technologies and Methods WORLD BIOPHARM FORUM 2017 To reserve your place please complete the registration form in BLOCK LETTERS

4 COMING SOON This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as quality by design and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities. Published by Wiley-VCH and available online and at all academic bookshops. Edited by Ganapathy Subramanian Continuous Biomanufacturing Innovative Technologies and Methods WORLD BIOPHARM FORUM 2017 To reserve your place please complete the registration form in BLOCK LETTERS and post it with full remittance to: Dr. G. Subramanian, 44 Oaken Grove, Maidenhead, Berkshire, SL6 6HH or, to Full Name:... Job Title:... Organisation:... Address: Postcode:... Country:... Tel: Any Special Requirement (Dietary):... Questions or Comments:... Registration Fees: Attendance, all meals and accommodation: 850 Attendance, all meals and no accommodation: 700 Payment Method: Online at www. subramanian.org.uk/ Conferences Cheques payable to Dr G. Subramanianin Pound Sterling only and drawn on a UK based bank or direct bank transfer. Cancellation: Should you be unable to attend, a substitute delegate is welcomed at no extra charge.

5 Produced by Hayward Design & Print hayward-design.co.uk

Continuous Biomanufacturing: Achievements and Challenges for Commercial Implementation

World Biopharm 2018_A5_Digital Proof 2 15/03/18 12:17 WORLD BIOPHARM FORUM 2018 Continuous Biomanufacturing: Achievements and Challenges for Commercial Implementation Lady Margaret Hall, University of