SPICA 2014

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
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Roman BURJA

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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.

Keynote Lecture
Continuous Processing by CCC/CPC: Where to Plug and How to Play When Everything is Fluid

Svetlana IGNATOVA

BRUNEL UNIVERSITY, Uxbridge, United Kingdom
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Svetlana IGNATOVA

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Dr Svetlana Ignatova is an Associate Professor at the Institute of Environment, Health and Societies and a Director of the Advanced Bioprocessing Centre at Brunel University, London. Her career has involved the application and development of Counter-current liquid-liquid extraction technology (often referred to as CCC). After she graduated from the Chemistry Department of Moscow State University (Russia) in 1993, she focussed on CCC theory and its application to inorganic and radioactive analysis culminating in her PhD, awarded in 2001 from Russian Academy of Sciences. After moving to Brunel University in 2003, Dr Ignatova worked closely with industry developing novel applications of CCC/CPC and its scale up. Her work on the recovery of actives from waste streams won a prize at SPICA 2012 in Brussels and she was recently invited to participate in a UK Government “Mission to China on Sustainable Manufacturing”.

Keynote Lecture
Multi-Column Chromatography: Challenges and Opportunities

Yoshiaki KAWAJIRI

GEORGIA INSTITUTE OF TECHNOLOGY, Atlanta, United States
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Yoshiaki KAWAJIRI

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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.

Keynote Lecture
Peptide Purification: State-of-the-Art and Challenges

Thomas MEIER

BACHEM AG, Bubendorf, Switzerland
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Thomas MEIER

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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.

Keynote Lecture
Pharmaceutical Small Molecule Purification: Where Are We and Where Do We Need to Be?

Larry MILLER

AMGEN, Thousand Oaks, United States
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Larry MILLER

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Larry Miller is a Principal Scientist in the Discovery Analytical Sciences group at Amgen in Cambridge, MA. He graduated with a BS degree from the University of Illinois in Urbana-Champaign and a MS from Roosevelt University. He has over 30 years of experience performing small molecule achiral and chiral purifications at the mg to multi-kg scale/ During his career he spent 20 years at Searle/Pharmacia and has spent the last 10 years at Amgen At Amgen he is responsible for discovery and early development purification support utilizing preparative SFC and HPLC. Larry has over 30 peer reviewed publications and over 35 presentations at scientific meetings and serves as co-instructor for SFC short courses in the US and Europe. In addition Larry is the current president of the Green Chemistry Group which organizes the annual SFC conference.

Keynote Lecture
Chromatographer: What Could Modeling Do for You?

Roger-Marc NICOUD

FOUNDER AND FORMER CEO NOVASEP, CONSULTANT, Nancy, France
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Roger-Marc NICOUD

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Roger-Marc Nicoud got a PhD from University of Lorraine in process simulation for the nuclear industry. He joined Separex in 1987, first as a Technical Director and then as a Managing Director until 1995. Between 1993 and 1995, he also occupied a position of Professor and head of a research laboratory involved in thermodynamics at the University of Lorraine. Roger-Marc Nicoud founded Novasep in 1995 with the vision to develop comprehensive solutions for the production of bio- and synthetic molecules. Novasep became a leader serving the life sciences industry with a recognized portfolio of innovative technologies. He held the position of CEO of Novasep until October 2012, and Chairman of the Novasep Supervisory Board until February 2014. Roger-Marc Nicoud is currently writing a book `Chromatographic processes: modelling, simulation and design` to be published early 2015 by Cambridge University Press .

Keynote Lecture
Chromatography and Crystallization: Good Partners in Separating Enantiomers

Andreas SEIDEL-MORGENSTERN

MAX PLANCK INSTITUTE FOR DYNAMICS OF COMPLEX TECHNICAL SYSTEMS, Magdeburg, Germany
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Andreas SEIDEL-MORGENSTERN

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Prof. Seidel-Morgenstern graduated at Technische Hochschule Leuna-Merseburg in 1983 (Dipl.-Ing. in Chemcial Engineering) and received a Ph.D. in 1987 from the Institute of Physical Chemistry of the Academy of Sciences in Berlin. Between 1991 and 1992 he worked as a postdoctoral fellow at the University of Tennessee in Knoxville. In 1994 he finished the Habilitation at the Technical University in Berlin. He acquired industrial experience working for Schering AG in Berlin (1995) before becoming Professor of Chemical Process Engineering at the Otto von Guericke University in Magdeburg. In 2002 he was appointed as a Director at the Max Planck Institute for Dynamics of Complex Technical Systems in Magdeburg, where he leads the department “Physical and Chemical Foundations of Process Engineering”. His research fields are mainly reaction engineering, heterogeneous catalysis, preparative chromatography and crystallization based separation processes.

Highly Active Small Molecules and Peptides: Intrinsic Reduction of Risks by the Use of Preparative Chromatography and Flow Technologies

Modeling and Optimization of the Twin Column Capture SMB Process

Overcoming Challenges in the Industrial Production of OMEGA-3S

Advances in Model-Based Inline Peak Deconvolution: Process-Data-Based Model Calibration and Real-Time Pooling Decisions

Peptide Purification Via Ion-Exchange Doped Reversed Phase Chromatography: a Combined Experimental and Modeling Approach

Extraction-Injection: an Alternative Sample Introduction Method for SFC

Implementation of Continuous Chromatography Under cGMP for the Pharmaceutical Industry

HTS Chromatographic Platforms: Small is Beautiful

Methodology for Scale-Up in Countercurrent Chromatography

Modelling and Simulation of the Purification of Cell Culture-Derived Influenza Virus Via Continuous Size Exclusion Chromatoghraphy

Reliable Scale-Up from Analytical to Large Scale Instrumentation in Chiral Supercritical Fluid Chromatography

Torgny FORNSTEDT

KARLSTAD UNIVERSITY, Karlstad, Sweden
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Torgny FORNSTEDT

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Torgny Fornstedt is a professor in Analytical Chemistry at Karlstad University, Sweden. He obtained a M.Sc. in Pharmacy at Uppsala University 1986, obtained a PhD in Analytical Pharmaceutical Chemistry at Uppsala University 1992 and was promoted to professor in Analytical Biotechnology at Uppsala University 2008. Torgny Fornstedt heads the internationally competitive Fundamental Separation Science Group (www.separationscience.se) at Karlstad University. The goal of the group is to conduct theoretically advanced fundamental research in the field of separation science and to cooperate with industry regarding purification of drug molecules and high-value chemicals. The group cooperate both with leading academic groups in Europe and USA and with leading companies. Specifically the group develops and applies numerical tools to characterize, validate and optimize analytical and preparative separation methods important for analytical chemists, biochemists and pharmaceutical chemists. The group is currently working with liquid chromatography (HPLC/UHPLC), Supercritical Fluid Chromatography (SFC) and biosensors (SPR/QCM). Two recent joint projects with AstraZeneca R&D in Mölndal aim (i) at linking solid separation theory in Quality by Design (QbD) of analytical processes and (ii) at deeper understanding and reliable scale up of SFC.

Preparative Chiral Chromatography. Summa Chiralogica

Pilar FRANCO

CHIRAL TECHNOLOGIES EUROPE, Illkirch, France
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Pilar FRANCO

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http://www.chiral.fr

Dr. Pilar Franco is the Technical Operations Manager at Chiral Technologies Europe (CTE). Pilar is an expert in the separation of enantiomers by chromatography at the analytical and preparative scale, and she oversees all technical operations for Chiral Technologies Worldwide. She joined CTE in 2002 as a Product Manager having previously worked with Ciba-Geigy (Basel, Switzerland), now known as Novartis, and in research and development with Almirall Prodesfarma (Barcelona, Spain). Dr. Franco earned her Ph.D. in Pharmacy from the University of Barcelona, studying the preparation and use of polysaccharide derivatives as chiral stationary phases for HPLC. As a Marie Curie Fellow from the European Commission, she also performed postdoctoral work on chiral separations with Dr. W. Lindner at the University of Vienna. Dr. Franco has authored more than 30 publications and five book chapters in her area of expertise.

Continuous Manufacturing in Biopharmaceutical Industries

Implementation of Model-Based Approach for Chromatography Development

pH Zone Refining in Centrifugal Partition Extraction. A Step Change in Productivity for Liquid-Liquid Chromatography Processes?

A New Dynamic Fractionation Method and Column Design for Size Separation of Bio-Polymer Particles

Three Column Intermittent Simulated Moving BED (3C-ISMB) Cromatoghraphy: Cascade Operation for Center-Cut Separations

Design of an Agarose Based Platform for Large Scale Chromatography

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
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Alois JUNGBAUER

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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.

Optimizing the Separation of MAB Charge Variants Using Model-Based Approaches

Purification of an Intermediately Eluting Component from a Complex Mixture

Separation of Lignans by Supercritical Fluid Simulated Moving BED

Implementing Integrated Continuous Downstream Processing

From Molecule to Process: Model-Based Design of Continuous Centrifugal Partition Chromatography

Mirjana MINCEVA

TECHNISCHE UNIVERSITÄT MÜNCHEN, Freising, Germany
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Mirjana MINCEVA

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Prof. Minceva studied Food science and biotechnology and Process engineering in Macedonia at the University Ss. Ciryl and Methodius. In 2004, she completed her PhD at the University of Porto (Portugal) in the group of Prof. Alirio Rodrigues. Subsequently she worked as an associate scientist in the same group and NATO Postdoctoral fellow in Macedonia. Between 2007 and 2014, she led the Chromatography group at the Chair of Separation Science and Technology (Prof. Wolfgang Arlt), University of Erlangen-Nuremberg, where she received her lecturer qualification in 2013. She was appointed assistant professor at Technische Universität München in July 2014.

Purification of Antibody Conjugates by MCSGP Chromatography

Modelling and Optimization of Preparative Chromatography Separation of Rare Earth Elements

Bernt NILSSON

LUND UNIVERSITY, Lund, Sweden
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Bernt NILSSON

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Prof. Bernt Nilson is professor at Department of Chemical Engineering, Lund University, Sweden. His research activities are in the field of mathematical modelling and simulation techniques, model calibration and optimization techniques, model based operation and control, model based engineering and computer tools with m ain applications:in protein chromatography for biopharmaceutical applications, and industrial chromatographic systems in pharmaceutical industries. He also conducts Industrial courses in industrial process simulation and process engineering. He has more than 70 peer reviewed publications in the field of process engineering and chromatography.

High Yeld Protein Refolding by Integrating Single-Column Chromatoghraphy and Membrane Filtration

Hardware Solutions Enabling Continuous Biomanufacturing

Integrated Reaction/Separation Process for High-Yield Pegylation

Unified Design of Chromatographic Separation Processes

Tuomo SAINIO

LAPPEENRANTA UNIVERSITY OF TECHNOLOGY, Lappeenranta, Finland
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Tuomo SAINIO

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Tuomo Sainio is currently professor in Laboratory of Separation Technology at Lappeenranta University of Technology (LUT), Finland. He earned his doctor of science degree from the LUT Laboratory of Industrial Chemistry at 2005. His research interests range from the fundamental phenomena in chromatography, ion exchange, and solvent extraction to development of process design methods for integrated separation processes. Main application areas are in biorefining and metal separations.

Implementation of a Negative Mode Platform for Virus Purification

Ricardo SILVA

IBET - INSTITUTO DE BIOLOGIA EXPERIMENTAL E TECHNOLOGICA, Oeiras, Portugal
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Ricardo SILVA

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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.

Saturation Capacity for Proteins in Ion Exchange Chromatoghraphy

Fabian STEINEBACH

ETH ZÜRICH, Zurich, Switzerland
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Fabian STEINEBACH

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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.

Scale-Up in Supercritical Fluid Chromatography

Continuous Processing of Self-Cleaving Fusion Proteins by Matrix-Assisted Refolding Separation Using SMB Size Exclusion Chromatography with Buffer Recycling

Integrated Counetr Current Chromatography (ICCC) - From SMB to a Fully Integrated Process

Steffen ZOBEL-ROOS

CLAUSTHAL UNIVERSITY OF TECHNOLOGY, Clausthal-Zellerfeld, Germany
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Steffen ZOBEL-ROOS

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Steffen Zobel was born in 1987. He studied process engineering at the Technical University of Clausthal and finished his studies in 2012 with the academical degree of Diplom Ingenieur. At the moment, He is a scientific assistant at the institute for separation and process technology at the technical university of clausthal. His field of research for his PhD studies under Prof. Strube are adsorptive processes, especially continuous chromatography.

From Development to Commercial Scale: Rules to Scale up, QbD, Regulatory, Process Validation

Alessandro BUTTE

ETH ZURICH, Zurich, Switzerland

Process Design for Purification of Biomolecules

Alois JUNGBAUER

UNIVERSITY OF NATURAL RESOURCES AND LIFE SCIENCES, Vienna, Austria
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Alois JUNGBAUER

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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.

Multicolumn Processes: From Historical SMB to the Latest Advances in the Purification of Biomolecules

Arvind RAJENDRAN

UNIVERSITY OF ALBERTA, Edmonton, AB, Canada

Preparative HPLC: Phase Screening, Method Optimisation, Process Development. Troubleshooting a Preparative Chromatographic Device

Process Design for Purification of Small Molecules and Peptides

Solving a Purification Process: Choice of the Appropriate Process (Centrifugal Partition Chromatography vs Countercurrent Chromatography, Batch vs Continuous, Low Pressure vs High Pressure, Liquid vs SFC)