WORLD BIOPHARM FORUM

2017

Continuous Biomanufacturing: Current Success and Future Trends

Lady Margaret Hall, University of Oxford, Oxford, UK

26th-28th June, 2017

www.subramanian.org.uk

MONDAY 26TH JUNE12.00 Noon Registration

12.50 Introduction

Dr G Subramanian

Strategies and Theory in CBChairman: Miriam Monge

1.00pmStrategies and points to consider for Continuous Biomanufacturing

Dr Parrish Galliher, Chief Technology Officer, GE Healthcare, USA.

1.30pmProcess design and engineering challenges for continuous biomanufacturing

Professor Jochen Strube, Director, Institute for separation technology, T.U.Clausthal, Germany

2.00pmChromatography Solutions for Integrated Continuous Bioprocessing

Dr Dana Pentia, Senior Application Scientist RepliGen – BioProcessing, USA.

2.30pmDevelopments in countercurrent protein polishing: theory and experiments

Professor Ajoy Velayudhan, Department of Biochemical Engineering, University College of London, UK.

3.00pmRound-table discussion: on optimisation and control of SMB for proteins.

Chairman: Professor Ajoy Velaudhan

3.30pmNetworking and Refreshments

Process and control EngineeringChairman Dr Paarish Galliher

4.15pmIntegrated control and monitoring of continuous biomanufacturing

Professor Richard Baartz, MIT, USA

4.45pmMulti-Parametric Control Strategies for Enabling Continuous Biomanufacturing

Professor Christoph Herwig, Institute of Chemical Engineering, VUT, Vienna, Austria

5.15pmProcess Intensification: Increased efficiency through coupling single-pass TFF to chromatography

Dr Mathilde Bourguignat, Merckgroup, Strasbourg, France.

5.45pmThe latest developments in process intensification and integration

Dr Gerben Zijlstra, Sartorius-Stedim Biotech, France.

TUESDAY 27TH JUNE

Materials, Design and Equipment EngineeringChairman Professor Jochen Strube

8.00amBeing spoiled for choice: single-use or stainless steel and how to perform proper scale-up

Dr Stefen Whieschaka, Rentschler Biotechnologie GmbH, Germany.

8.30amProcess intensification strategies by Novasep

Dr Thomas Flouquet, Group Novasep, France.

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, 2017.

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.

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

Sponsored by

*

* The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada.

9.00amImpact of facility design and operation (operating model) when mounting into CM

Dr Morten Munk, Global Technology Partner, NNEpharmaplan, Denmark.

9.30amPanel 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.

10.00am Networking and refreshments

Emerging Applications, and Regulation Chairman Andrew Clutterbuck

10.30amContinuous manufacturing of extracellular vesicle reference materials

Dr William Whitford, Strategic Solutions Leader Cell Culture, Bioprocess, GE Healthcare, USA

11.00amIntegrated 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

12.00 NoonRobust operation of Protein SMB

Chris Wayne, Department of Biochemical Engineering, University College of London, UK

12.30pmRegulatory aspects of integrated continuous downstream processing: continuously making safe biotherapeutics and maintaining traceability

Dr Marc Bisschops, Principal Scientist, Pall Lifesciences

1.00pmLunch

Continuous Cell Culture/ Perfusion BioreactorsChairman Marc Bisschops

2.00pmInvited Lecture: “Perspective of scale-down systems for high-cell density perfusion of mammalian cell culture”

Dr Veronique Chotteau, KTH, Royal Institute of Technology, Sweden

2.30pmPerfusion-based production of inoculum cultures for Large volume cell banks

Ina Dittler, Institute of Chemistry and Biotechnology, Switzerland

3.00pmPlug-flow tubular and stirred tank for continuous vaccine production: virus stability and interference by defective particle

Dr Filipe Tapia, Maxplank Institute Magdeburg, Germany.

3.30pmAccelerate Cell Culture Development Using the Modular Automated Sampling Technology (MASTTM) Platform

Dr Clint Pepper, Director, MAST Products Capsugel BRIO: 63050 Corporate Pl. Bend OR, 97701 USA

4.00pmNetworking and Refreshments

4.30pmSingle-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

5.00pmInfluence of cell culture medium on the economy of perfusion processing

Delia Lyons, Sial, USA

5.30pmApplication of perfusion in vaccine production using drosophila S2 insect cells

Dr Wian de Jung, CSO, Expres2ion, Denmark.

6.00pmContinuous 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 ProcessingChairman Dr Yan-Ping Yang

9.00amQualification and validation approach for phase 1 GMP continuous manufacturing of Mab

Maarten Pennings, CTO, Biosanapharma, The Netherlands

9.30amContinuous countercurrent tangential chromatography for monoclonal antibody purification

Professor Andrew Zydney, Department of Chemical Engineering, PSU, USA

10.00amEvolution of Mab processing: The opportunity represented by next generation processing

Dr Chase Duclos Orsello, Global Marketing Head, MilliporeSigma, USA.

10.30amNetworking and Refreshments

11.00amOptimising multi-column Protein A chromatography

Dr Michael Rose, UCB, Slough, UK

11.30amCase Study: Comparing Cost of Manufacturing between Batch vs Continuous Manufacturing Process for Mabs.

Priyanka Gupta – global senior bioprocess modelling consultant, India

12.00 NoonCase Study: Large scale continuous purification of Mab: seamless scale-up from grams to kilograms

Dr Marc Bisschops, Principal Scientist, Pall Lifesciences.

12.30pmConcluding Remarks:

Dr William Whitford, Strategic Solutions Leader Cell Culture and Bioprocess. GE Healthcare, USA.

1.00pmLunch

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.

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, email to gsub@subramanian.org.uk

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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.

Edited by Ganapathy Subramanian

Continuous BiomanufacturingInnovative Technologies and Methods

Produced by Hayward Design & Print hayward-design.co.uk • 01227 721 864