Session 5: Protein and Peptide Purification
Session Chair
Olivier LUDEMANN-HOMBOURGER
POLYPEPTIDE LABORATORIES FRANCE, Strasbourg, France
Session Co-Chair
Jeannie HORAK
UNIVERSITY OF TUEBINGEN, Tuebingen, Germany
08:30
Keynote Lecture
Peptide Purification: State-of-the-Art and Challenges
Thomas MEIER
BACHEM AG, Bubendorf, Switzerland
Thomas Meier is Vice President Manufacturing and member of the Executive Committee at Bachem AG, Bubendorf, Switzerland. He studied Chemistry at the Swiss Federal Institute in Zurich (ETHZ, Switzerland) and the Zurich University of Applied Science. He joined Bachem AG in 1993 as a peptide bench chemist. In 1997 he was promoted Director API. From then on, he led the API manufacturing department in Bachem, and was promoted Vice President Production in 2008. He was involved in numerous interdisciplinary teams developing, implementing and executing cGMP peptide API manufacturing processes, thus innovating large scale peptide manufacturing in a cGMP regulated environment. In addition he led the Solid-Phase Peptide Synthesis and Purification extension project that designed, installed and qualified large scale peptide synthesizer and preparative HPLC systems.
From 2001 till 2004 he was in charge of Peptide manufacturing at Peninsula Inc. in San Carlos, California.
09:10
High Yeld Protein Refolding by Integrating Single-Column Chromatoghraphy and Membrane Filtration
Sebastian NIMMIG
FRIEDRICH-ALEXANDER-UNIVERSITY, Hanau, Germany
Mr. Sebastian Nimmig studied process engineering at the Otto-von-Guericke University in Magdeburg, Germany. He obtained his Diploma in 2011. Subsequently he became a researcher at the Institute of Separation Science and Technology in Erlangen, Germany, at the group of Prof. Kaspereit. Currently Mr. Nimmig is doing his research in the field of integrating chromatography, membrane processes and biochemical reactions to graduate as PhD.
09:30
Saturation Capacity for Proteins in Ion Exchange Chromatoghraphy
Fabian STEINEBACH
ETH ZÜRICH, Zurich, Switzerland
Fabian Steinebach grew up in Konstanz, Germany. In 2008 he joined ETH Zurich to study chemical engineering. He obtained his MSc in Chemical and Bioengineering in 2012, after completing his master thesis, entitled “Development of a PID controller for the twin-column MCSGP process” in the Morbidelli group. In 2012 he became a PhD candidate under supervision of Prof. Morbidelli, working on multi-column chromatography and fundamental understanding of ion exchange chromatography.
09:50
HTS Chromatographic Platforms: Small is Beautiful
David DELVAILLE
MERCKSERONO, Martillac, France
David Delvaille studied biotechnology and received his engineer degree at ENSTBB (Bordeaux Biotech school) before joining Serono based in Martillac (Bordeaux's area). After acquisition of Serono by Merck KgAa and the decision to turn the site to production of biomolecule using microorganisms, he became Dowstream supervisor in the Process Development group. Responsible for development of processes from tox phase up to phase III and ensuring technical transfers at large scale. His interests moved towards the assessment and integration of New technologies in the filed of process downscaling, technically mandatory to ensure QbD approaches applied in Merck Serono's Biotech processes. His group develops future platform that should ensure fast, reliable and cost effective processes for large scale production.
10:10
Peptide Purification Via Ion-Exchange Doped Reversed Phase Chromatography: a Combined Experimental and Modeling Approach
Gianluca BUFFOLINO
ZEOCHEM AG, Uetikon am See, Switzerland
Gianluca Buffolino was born in 1989 in Zurich, Switzerland. He graduated with a bachelor's degree in 2012 at the Zürcher Fachhochschule für Angewandte Wissenschaften (ZHAW). After his degree he started as projectleader at the Zeochem AG in Uetikon (Switzerland). The huge part of his job was to synthesize new reversed phases on spherical Silicagel and to compare with the main phases on the market.
10:30
Session 6: Purification of Biopharmaceuticals
Session Chair
Michael SCHULTE
MERCK KGAA, Darmstadt, Germany
Session Co-Chair
Kathleen MIHLBACHLER
LEWA GMBH, Leonberg, Germany
11:00
Integration of Continuous Precipitation and Flow Through Chromatography with Monoliths for Purification of Recombinant Antibodies
Alois JUNGBAUER
UNIVERSITY OF NATURAL RESOURCES AND LIFE SCIENCES, Vienna, Austria
Professor Alois Jungbauer received his PhD in Food Technology and Biotechnology from the University of Natural Resources and Life Sciences Vienna, Austria 1986. He serves since then as a professor at the Department of Biotechnology. He teaches Protein Technology and Downstream Processing and Biochemical Engineering. Professor Jungbauer is head of the laboratory for Protein technology and Downstream Processing. He also acts as area head and Dep. Director of Research in the Austrian Centre of Industrial Biotechnology. He is currently working in the field of bioengineering of proteins, plasmids and viruses with special focus on expression, downstream processing and characterization of large biomolecules. As a proliferate researcher he has more than 250 publications on recombinant protein production and bioseparation, 15 patents and 12 book contributions and recently a monograph entitled “Protein Chromatography , Process Development and Scale Up”. He is executive editor and co-founder of Biotechnology Journal, and member of editorial boards from numerous journals in the area of biochemical engineering.
11:20
Purification of Antibody Conjugates by MCSGP Chromatography
Thomas MÜLLER-SPÄTH
CHROMACON AG, Zurich, Switzerland
Thomas Müller-Späth, Dr. sc. ETH, Dipl.-Ing., holds a COO position at ChromaCon AG, Switzerland. He finished his studies in chemical engineering with a diploma thesis in the area of fermentation technology at the Technical University Hamburg, Germany. During a 1-year stay at the University of California, Berkeley (USA), he deepened his knowledge in biotechnology. During an 8-month internship in the Factor-VIII production at Bayer Healthcare in Berkeley (USA), he investigated the application of chromatography for purification and participated in further education in the area of GMP (Good Manufacturing Practice). Thomas obtained his PhD in the area of continuous chromatography for the purification of proteins in October 2008 under the guidance of Prof. Morbidelli.
11:40
Implementation of a Negative Mode Platform for Virus Purification
Ricardo SILVA
IBET - INSTITUTO DE BIOLOGIA EXPERIMENTAL E TECHNOLOGICA, Oeiras, Portugal
Ricardo Silva received his Master degree in Chemical and Biochemical Engineering from Faculdade de Ciências e Tecnologia – Universidade Nova de Lisboa in 2008. His Phd studies, developed under the supervision of Prof. José Paulo Mota, focused on the development and optimization of countercurrent adsorption processes.
At the moment, he is a post-doc at Animal Cell Technology Unit in iBET, working in downstream processing targeting continuous purification processes and identification of new purification strategies for viral vaccines and vectors.
12:00
Optimizing the Separation of MAB Charge Variants Using Model-Based Approaches
Rushd KHALAF
ETH ZÜRICH, Zurich, Switzerland
Rushd Khalaf grew up in Montréal, Québec, Canada. From 2006 to 2010, he attended McGill University in Montréal, graduating with a B.Eng. in chemical engineering, having completed projects in the fields of pulp and paper and thermodynamics. In the fall of 2010, he joined the ETH in Zurich for master level studies. He completed his master thesis, entitled “Experimental Study and Modeling of a Purification Process”, in the Morbidelli Group. He obtained a Master of Science degree from the ETH in chemical and bio-engineering in early 2012. Shortly after, he joined the Morbidelli group as a PhD candidate, working towards better understanding and application of chromatographic processes.
12:20
Lunch Break sponsored by AMPAC FINE CHEMICALS
Vendor Seminars by Novasep, Merck Millipore, Chiral Technologies Europe and Agilent Technologies (12:30-13:30)
13:30
Poster Session #2
(presentation of posters with odd numbers)
Session 7: Industrial Purification Processes
Session Chair
Eric VALERY
NOVASEP CDMO, AN AXPLORA COMPANY, Pompey, France
Session Co-Chair
Galatea PAREDES
NOVARTIS PHARMA, Basel, Switzerland
14:30
Keynote Lecture
Industrial Preparative HPLC for Production of API Including Most Common Unit Operations; Membrane Operations, Evaporation, Crystallization
Roman BURJA
LEK PHARMACEUTICALS D.D., Menges, Slovenia
Roman Burja is Head Technical Life Cycle Management and Manufacturing Science & Technology Site Head at Lek Pharmaceuticals d.d. at Menges Site. He finished study of Chemical engineering at University of Ljubljana in 2001. The same year he joined Lek as Process Engineer in Development and then assumed roles with increased responsibility. In 2003 he worked as Project Manager responsible for pHPLC process scale up and production of API. In 2007 he joined API Production as site leadership team member for the execution of product and technology transfers, validation of manufacturing processes and use of up to date technology. In his current role he works in the field of technology transfers, scale up and process optimization including pHPLC, synthesis, membrane operations and complex API crystallization.
15:10
Overcoming Challenges in the Industrial Production of OMEGA-3S
Jean BLEHAUT
NOVASEP GROUP, Pompey, France
15:30
Design of an Agarose Based Platform for Large Scale Chromatography
Hans JOHANSSON
PUROLITE, Uppsala, Sweden
Hans J Johansson is application manager at Purolite R&D, Llantrisant, Wales. He has over thirty years experience in the biotech industry. He has spent most of his professional career in research and development with a special focus on industrial chromatography applications. He frequently publishes in scientific papers and is the holder of many patents and patent applications in the area of resin design and large scale protein purification. He is currently working with the design and development of a new, agarose-based, chromatography platform.
15:50
Continuous Manufacturing in Biopharmaceutical Industries
Holger FROEHLICH
CLAUSTHAL UNIVERSITY OF TECHNOLOGY, Clausthal-Zellerfeld, Germany
16:10
Session 8: Multicolumn Chromatography
Session Chair
Massimo MORBIDELLI
ETH ZÜRICH, Milano, Italy
Session Co-Chair
Ernst FREUND
NOVARTIS PHARMA AG, Basel, Switzerland
16:30
Keynote Lecture
Multi-Column Chromatography: Challenges and Opportunities
Yoshiaki KAWAJIRI
GEORGIA INSTITUTE OF TECHNOLOGY, Atlanta, United States
Dr. Yoshiaki Kawajiri is an assistant professor in the School of Chemical & Biomolecular Egnineering at Georgia Institute of Technology, USA. He earned his Master and Bachelor of Engineering degrees in chemical engineering from Kansai University in Osaka, Japan in 1997 and 1999, respectively. After working as an R&D engineer at Organo Corporation in Saitama, Japan for four years, he completed his Ph.D. in chemical engineering at Carnegie Mellon University in the U.S. in 2007. Then he carried out his postdoctoral study at the Max Planck Institute for Dynamics of Complex Technical Systems in Magdeburg, Germany, supported by an Alexander von Humboldt Research Fellowship. His research interests include modeling, optimization, and design of novel separation processes for chemical, pharmaceutical, and energy industries, such as simulated moving bed chromatography, crystallization, and adsorption process for carbon capture.
17:10
Three Column Intermittent Simulated Moving BED (3C-ISMB) Cromatoghraphy: Cascade Operation for Center-Cut Separations
Simon JERMANN
ETH ZÜRICH, Zurich, Switzerland
Simon Jermann received his Bachelor degree in Chemical Engineering from ETH Zurich in 2008 after spending parts of his education at Imperial College London. He continued his studies at ETH Zurich within the Excellence Scholarship and Opportunity Programme and graduated 2009 with a Master degree in Chemical and Bioengineering. After his master thesis under the supervision of Prof. Dr. Manfred Morari (Automatic Optimizing Control of Simulated Moving Bed (SMB) Chromatography) he joined Prof. Dr. Marco Mazzotti's group to continue his research in the field of chromatography. His main research interest is the development of new intermittent SMB processes to both enhance the performance of binary separations and facilitate ternary separations. Besides that, he is interested in the quantitative description of the Delta-shock phenomenon.
17:30
Purification of an Intermediately Eluting Component from a Complex Mixture
Kiara KOCHENDOERFER
BASF SE, Ludwigshafen, Germany
Kiara Kochendörfer studied process engineering at Technische Universität Berlin. During her studies, she went to Imperial College London and National University of Singapore at the Department of Chemical Engineering. After her graduation in 2009, she was PhD student in the group of chromatography under the supervision of Prof. Dr. Arlt in Erlangen at the Friedrich-Alexander-University Erlangen-Nuremberg. Her research topic was “Purification of an Intermediately Eluting Component from a Complex Mixture”. In 2013, Kiara joint BASF and continued working in the field as a research engineer in the Team Adsorption and Ion Exchange.
17:50
Continuous Processing of Self-Cleaving Fusion Proteins by Matrix-Assisted Refolding Separation Using SMB Size Exclusion Chromatography with Buffer Recycling
Martin WELLHÖFER
CELONIC AG, Basel, Switzerland
Martin Wellhöfer studied biochemical engineering at the technical University of Karlsruhe (KIT), Germany, before he joined the working group of Prof. Alois Jungbauer at the University of Natural Resources and Life Sciences Vienna (BOKU), Austria. After receiving his PhD in 2013 he joined Celonic AG in Basel, Switzerland, where he is currently heading the DSP department responsible for process development and GMP production.
18:10
Panel discussion: Bridging Purification and Flow Chemistry?
Discussion animated by Berthold SCHENKEL (Novartis, Switzerland), Andreas SEIDEL-MORGENSTERN (MPI for Dynamics of Complex Technical Systems, Germany) and Olivier DAPREMONT (AMPAC Fine Chemicals, United States)
19:00
20:00