Innovative technologies and methods in supporting continuous Biomanufacturing

Transcription

1 World Biopharm 2015_A5 Proof 8 10/03/15 9:21 WORLD BIOPHARM FORUM 2015 Innovative technologies and methods in supporting continuous Biomanufacturing Robinson College, Cambridge, UK 23rd-24th June,

2 A WARM INVITATION TO COME AND JOIN US IN CAMBRIDGE I invite you to join us at the Second International Meeting on Innovative Technologies & Methods Supporting Continuous Biomanufacturing which will be held at Robinson College, Cambridge, UK on June 23/24, Continuous biomanufacturing requires the ability to think laterally and have a proactive mindset across the entire team from development to production. Today Biopharma industries accept Continuous Manufacturing Process as a novel approach to efficiently and economically produce a therapeutic product. However there are some bottlenecks still to overcome. Single use continuous processing has yet to tick all the boxes from the industry s viewpoint. Over the last few years interest in continuous bioprocessing has grown considerably due to the ongoing developments of technologies and advancing their application to meet the need of the manufacturers. Such is the interest that several leading biopharm companies together with vendors and academics are developing the technologies to apply in their manufacturing process. The conference is enhanced by the participation of 26 leading industrial technologists, scientific vendors and also six leading academics from Europe and USA. They have come forward to share their experience and knowledge to provide a better understanding of the current technologies and their application in continuous biomanufacturing. There is also a plenary lecture by a distinguished professor in the field of bioprocessing, and you will also benefit from access to unpublished data. This meeting will address several advancements and their successful application with data, and project to the future direction of the industry. By joining with us you can benefit from the current state of-the-art advancements in continuous manufacturing and also learn about the successful organisations that are developing these methods in-house. Together we will drive change, innovate growth and pioneer smarter technologies to ensure they reach their full potential. I look forward to welcoming you to Robinson College in the beautiful city of Cambridge. G.Subramanian TUESDAY 23RD JUNE Noon Registration 1.00pm Welcome and Introduction Dr G Subramanian 1.15pm Plenary Lecture - From advanced PAT to QbD-compliant quasi-continuous integrated pharmaceutical production Prof. Reiner Luttmann, HAW-Hamburg University of Applied Sciences, Germany Upstream Biprocessing: approaches and application in CB Chairman: Professor Peter Neubauer 2.00pm Perfusion-Based Production platform for Biopharmaceuticals Professor Roland Wagner, VP Bioprocess Development, Rantschler Biotechnologie GmbH, Germany 2.15pm Perfusion process and medium development for production of Biopharmaceuticals Dr Jochen R. Sieck, Head of Lab, Cell Culture Peformance, Merck Millipore, Germany 2.30pm Development of Perfusion process: aspects related to temperature and medium supplementation Professor Leda Castilho, Universitade de la Federal de Rio de Janeiro, Brasil 2.45pm Perfusion based production of vaccines using Drosophila S2 insect cell Dr Wian de Jongh, Expre2ionbio, Denmark 3.00pm Scanning growth space of cells using continuous cultivation as a tool for the understanding of quantitative peculiarities of cellular metabolism and optimization of biotechnological process Professor Raivo Vilu, Tallinn University of Technology, Estonia 3.15pm Refreshments and Networking Downstream processing in CB Chairman: Professor Leda Castilho 4.00pm Continuous downstream processing for monoclonal antibodies - Are we there yet??dr Sanchayita Ghose, Associate Director/principal Engineer, Biogen Idec, USA 4.15pm Bringing continuous chromatography to your bench Jill Simon Global Product Manager, GE Healthcare, Sweden 4.30pm Disposable continuous chromatography as an enabling technology, across for continuous manufacturing during the life cycle of pharmaceutical product Dr Marc Bisschops, Scientific Director, Tarpon Biosystem, The Netherlands

3 Cell Retention Technologies 4.45pm Continuous processing beyond traditional perfusion using single-use centrifuge Dr Sunil Mehta, VP Operations, KSep Systems, USA Integration of continuous upstream and downstream in CB Chairman: Dr Nico Oosterhuis 5.00pm Continuous manufacturing in biopharmaceutical industries Dr Steffen Zobel, Clausthal University of Technology, Germany 5.15pm Technologies upstream and downstream to aid in continuous biomanufacturing Dr James Rusche, Sr VP Research and Development, Repligen Corp, USA 5.30pm MoBIDIK: fully integrated continuous processing for mabs Dr Peter Schwan, Filtration and membrane technology, Bayer Technology Services GmbH, Germany Engineering and Materials design 5.45pm Equipment and material design enabling upstream CB Dr William Whitford, GE Healthcare, Utah, USA Quality and Regulatory Chairman: Dr Marc Bisschops 6.00pm Continuous processing: Quality by design approaches for process control strategy and batch definition Richard Francis, Francisbiopharma, UK 6.15pm Towards industry 4.0 in biotech: QBD by parallelisation, automation and model supported design Professor Peter Neubauer, Technische University at Berlin, Germany 6.30pm Requirements for continuous chromatography in biopharmaceutical manufacturing. A CMO End user s perspective Dr Lee Allen, Lonza Biologics, UK 8.00pm Gala Dinner WEDNESDAY 24TH JUNE Single use Solutions Chairman: Dr William Whitford 8.00am Implementation of single use technologies for continuous processing and facility Fit applications Dr Michael W. Phillips, Director, Process Development R&D, EMD Millipore, USA 8.15am Continuous culture in the age of single use Dr Miriam Monge, Director of Marketing Integrated Solution, Sartorius Stedim, FMT, S.A.S, France 8.30am Continuous Bioproecessing in single use bioreactors, trends and developments Dr Nico Oosterhuis, Celltainer Biotech BV, The Netherlands 8.45am Evaluation of single use bioreactors for continuous processing Dr Andrew Clutterbuck, Biomanufacturing Engineer, Merck Millipore, France Continuous control systems Chairman: Dr Christel Fenge 9.00am Automation of single use harvest steps facilitates the control of continuous culture Dr Nick Hutchinson, Parker Hannifin, UK 9.15am Advances towards automated continuous processing Mabs Dr David Pollard, Merck Inc., USA 9.30am Data management and control strategies for continuous bioprocessing Dr Kjell Francois, Siemens NV, Belgium 9.45am Software developments to help optimise manufacture-lucullus Dr Timo Keijzer, Applokon, The Netherlands 10.00am Refreshments and Networking 11.00am Bioprocess monitoring challenges in continuous processing Dr Jarka Glassey, Reader, Newcastle University, UK Continuous case studies Chairman: Dr David Pollard 11.15am Continuous manufacturing, an overview cost and facility impact implications Dr Andrew Sinclair, CEO, Biopharmservices, UK 11.30am Business case study for continuous biomanufacturing Dr Veena Warikoo, Scientific Director Purification, Genzyme, A Sanofi company USA 11.45am Case Study: Continuous processing at 2000L single use bioreactor scale Dr Christel Fenge, VP Fermentation Technologies, Sartorius Stedim Biotech, Germany 12.00pm Once through continuous slurry processing Professor Frans Muller University of Leeds, UK Continuous Business Case 12.15pm Cost of goods Modelling and optimisation of continuous and pre-packed disposable chromatography. Dr Richard Allmendinger, The advanced centre for Bioprocess Engineering, University College of London, UK 12.30pm Integrated Continuous Manufacture of mabs Prof. Dr. Massimo Morbidelli, Institute for Chemical and Bioengineering, ETH Zurich, Switzerland 1.00pm Concludes and Lunch

4 AVAILABLE NOW With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems. WORLD BIOPHARM FORUM 2015 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 gsub@subramanian.org.uk Full Name:... Job Title:... Organisation:... Address:... Edited by Ganapathy Subramanian Continuous Processing in Pharmaceutical Manufacturing... Postcode:... Country:... Tel: Any Special Requirement (Dietary):... Questions or Comments:... Registration Fees: Attendance, all meals and accommodation: 750 Attendance, all meals and no accommodation: 600 Cheques payable to Dr. G. Subramanian in Pound Sterling only and drawn on a UK based bank or by Direct bank transfer. For other methods please see Cancellation: Should you be unable to attend, a substitute delegate is welcomed at no extra charge.

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