Session 5: Pharmaceutical Industry
08:30
Introduction by session chair
08:35
Small Molecule Chromatographic Purification in Pharmaceutical R&D and Manufacturing (KL05)
Dr Larry MILLER
AMGEN, Thousand Oaks, United States
Larry Miller is a Senior 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 16 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, over 40 presentations at scientific meetings and serves as co-instructor for SFC short courses in the US, Europe and Asia. In addition, Larry is the President of the Green Chemistry Group which organizes the annual SFC conference.
09:15
Preparative Separation by Chromatography from Laboratory to Industrial Scale in a Pharmaceutical Environment Applied to Small Molecules (IL05)
Dr Antoni SEVERINO
UCB, Braine-l'Alleud, Belgium
Antoni Severino is currently Principal Scientist - Global Analytical Sciences at UCB Biopharma Belgium for 8 years. As a Chemical Process Engineer, he completed a PhD in Chemical Engineering at the University of Mons in Belgium. This thesis was entitled “Experimental Study, Dynamic Modelling and Optimization of the Operating Conditions of Chromatographic Separation Processes by Simulated Moving Bed (SMB)”. At UCB, he is responsible for the large scale purification and chiral separation platform within Global Discovery Chemistry Department. His group supports Medicinal Chemistry Research in Braine-l’Alleud (Belgium) and Slough (UK) by HPLC and SFC but also Development and Manufacturing for MCC processes. In addition to daily support within NCE research, Antoni and his team contribute to the development of integrated automated platforms for small/mid-scale achiral purification as part of the global effort to improve digitalization and data management.
09:40
New Purification Strategy of Polyether Block Copolymers by Means of Simulated Moving Bed Size Exclusion Chromatography (OC09)
Dr Pedro SÁ GOMES
BASF SE, Ludwigshafen am Rhein, Germany
10:00
New Approaches in Preparative Chromatography for Lipid Nanoparticle (LNP) Building Blocks (OC10)
Dr Markus JUZA
CORDEN PHARMA SWITZERLAND, Liestal, Switzerland
Dr. Juza studied in Stuttgart, Germany, and received his doctorate in Tübingen in the field of enantioselective chromatographic methods in GC, HPLC, SFC and CE.
After a post-doctoral stay at the ETH in Zürich with Professor Morbidelli, Mr. Juza headed the preparative HPLC / SMB department for companies in Switzerland and France for over a decade before returning to analytical work in the field of pharmaceuticals again.
Since 2015, Mr. Juza is working with Corden Pharma Switzerland as a senior expert for chromatographic separation processes.
10:20
Coffee break & Exhibition
Session 6: Automation and Simulation
10:50
Introduction by session chair
10:55
Automation and Digitalization in the Manufacturing of Therapeutic Proteins (KL06)
Prof. Massimo MORBIDELLI
POLITECNICO MILANO, Milano, Italy
Massimo Morbidelli received his Laurea in Chemical Engineering at the Politecnico di Milano and PhD at the University of Notre Dame. He is currently Professor at the Politecnico di Milano (Italy) and Professor Emeritus at the ETH Zurich (Switzerland).
His main research interest is in the area of biopharmaceutics and specifically on the integrated continuous manufacturing of therapeutic proteins, and its automation and digitalization.
Massimo Morbidelli is co-author of more than 750 papers, 23 international patents and six books, including the very recent ones on Continuous Biopharmaceutical Processes (2018), Cambridge University Press, coauthored with D Pfister and L Nicoud and Perfusion Cell Culture Processes for Biopharmaceuticals (2020), Cambridge University Press, coauthored with M Wolf and J-M Bielser. He is the first chemical engineer elected to the Italian Academy of Science (Accademia dei Lincei), serves as the Executive Editor of the ACS journal of Industrial & Engineering Chemistry Research, and is the recipient of:
- R.H. Wilhelm Award in Chemical Reaction Engineering by the American Institute of Chemical Engineers, 2005
- Gerhard Damköhler-Medaille of DECHEMA.and VDI-GVC, 2014
- Excellence in Process Development Research Award by the American Institute of Chemical Engineers, 2017
- Separations Science and Technology Award by the American Chemical Society, 2018
- ICB Award, Contributions to Integrated Continuous Biomanufacturing, 2019
- Laurea Honoris Causa, Slovak University of Technology, Bratislava, 2019
In his career he advised more than 100 PhD students. He is a cofounder of ChromaCon Ltd., a spin-off company from his research group, which brings new chromatographic processes (MCSGP-technology) for the purification of proteins and peptides to the market (now acquired by YMC, Japan) and of DataHow Ltd. for the application of data science and machine learning in Biotechnology and specifically in the Biopharma Industry.
11:35
Strategies and Emerging Technologies for Downstream Purification (IL06)
Dr Gunnar MALMQUIST
CYTIVA, Uppsala, Sweden
Dr. Gunnar Malmquist is a Senior Principal Scientist within the BioProcess R&D at Cytiva and has over four decades of chromatography experience. His current focus is resin design strategies, Quality by Design, and process analytical technology together with empirical and mechanistic modelling of chromatography data for smarter process development and increased process understanding. Gunnar started his career at Pharmacia Biotech in 1979, working with quality control of chromatographic separation resins. He was later involved in the development of the ÄKTA chromatographic system and the UNICORN software, before moving on 1997 to characterization strategies and design of preparative chromatographic resins. He has been responsible for the design of several of the leading resins on the market, including MabSelect and Capto. Gunnar graduated 1993 from Uppsala University with a Ph. D. in Analytical Chemistry with emphasis on multivariate data analysis applied to chromatographic separations.
12:00
General Bio-Chromatographic Digital Twin in Quality-By-Design Based Process Design and Machine-Learning Based Process Control (OC11)
Mr Florian VETTER
TU CLAUSTHAL, Clausthal-Zellerfeld, Germany
12:20
Hybrid Models for the Simulation and Prediction of Chromatographic Processes (OC12)
Dr Alessandro BUTTE
DATAHOW, Zurich, Switzerland
12:40
Lunch break, Exhibition & Vendor Seminars
12:50
12:50
Tosoh Bioscience Seminar
Multi-column chromatography – A powerful tool to enhance productivity in downstream processing
12:50
RotaChrom Technologies LLC Seminar
CPC Simulator – Accelerating Method Development in Centrifugal Partition Chromatography
12:50
De Dietrich & Thar Process Seminar
Title to be announced
Session 7: Continuous Chromatography
13:55
Introduction by session chair
14:00
Cyclic Adsorption Processes. What else? (KL07)
Prof. Alirio RODRIGUES
UNIVERSITY OF PORTO, Porto, Portugal
Alírio Rodrigues graduated in Chemical Engineering (1968) at University of Porto (Portugal) and received his Dr. Ing degree (1973) from the Université de Nancy (France). After teaching at the University of Luanda and University of Évora, he joined the Chemical Engineering Department at FEUP in 1976, where he is an Emeritus Professor (since 2013). He has been Visiting Professor at Université Technologie Compiègne, University of Virginia, Universidad de Oviedo and Universidade Federal Ceará. He was the founder of LSRE. His research activities are focused on cyclic adsorption/reaction processes (pressure swing adsorption, simulated moving bed, electric swing adsorption, expanded bed adsorption, parametric pumping) for olefins/paraffins separation, CO2 capture, hydrogen purification, proteins separation, etc., lignin valorization, perfume engineering and microencapsulation. His teaching activities were focused on chemical reaction engineering, separation processes, product engineering and system dynamics and process control. He has supervised more than 60 PhD students and published 740 papers in peer-reviewed journals (h-index of 67; source: Scopus, February 2020), several books and patents.
14:40
Chromatography in Colour – Application of Processes Chromatography to the Efficient Recycling of Critical Metals (IL07)
Dr Paul O'SHAUGHNESSY
JOHNSON MATTHEY, Oxfordshire, United Kingdom
Dr Paul O’Shaughnessy is a Senior Principal Scientist at Johnson Matthey’s R&D centre in the UK - JMTC. He joined Johnson Matthey’s Platinum Group Metal Refining Research Group in 2003 following graduate and post-doctoral work as a chemist working on novel metal-ligand chemistries for homogeneous catalysis applications. Since that time his work has focused on separation and purification science and process technologies, specialising in liquid/liquid and solid/liquid separation processes including solvent extraction, chromatography, ion exchange and solid phase extraction. Working in a cross disciplinary commercial research environment he has worked on diverse separation R&D challenges in a wide range of businesses from hydrometallurgy and critical metals recycling to small molecule API and bio-chromatography processes. His work focuses on developing a fundamental understanding of the separation chemistry and applying that understanding to the design and optimisation of separation materials and processes at scale. He has developed patents for novel PGM chromatography separation processes, new solid phase materials for selective PGM and battery materials recycling and was also responsible for successfully introducing chromatography modelling and simulation tools into JMs commercial small molecule API chromatography process development and plant operations. For this work he was awarded the JM global technology innovation prize in 2019.
15:05
Continuous Size Fractionation of Nanoparticles for Biomedical Purposes Using Magnetic Field Controlled SMB (OC13)
Ms Laura KUGER
KARLSRUHE INSTITUTE OF TECHNOLOGY (KIT), Eggenstein-Leopoldshafen, Germany
Laura Kuger studied Bioengineering at Karlsruhe Institute of Technology (KIT), Germany. She is now working as a associate researcher at the Institute of Functional Interfaces (IFG) and pursuing her PhD in the group of Prof. Matthias Franzreb. Her research focuses on the fractionation of ultra-fine particles by magnetic field controlled chromatography, including process transfer to continuous working systems.
15:25
Simulated Moving Bed Chromatography - Mass Spectrometry (SMB-MS): Continuous On-Line Sample Preparation for Process Analytical Technology (OC14)
Ms Juliane DIEHM
KARLSRUHE INSTITUTE OF TECHNOLOGY, Karlsruhe, Germany
Juliane Diehm studied Bioengineering at the Karlsruhe Institute of Technology (KIT, Germany), where she is now pursuing her PhD at the Institute of Functional Interfaces in the Research Group of Prof. Matthias Franzreb.
15:45
Session 8: Optimization & Prediction
16:15
Introduction by session chair
16:20
What is the Right Level of Purity? Benefits of Overpurifying and Underpurifying in Chromatography (KL08)
Prof. Tuomo SAINIO
LAPPEENRANTA UNIVERSITY OF TECHNOLOGY, Lappeenranta, Finland
Tuomo Sainio is professor in Separation Processes at LUT University (Lappeenranta, Finland) since 2014. He graduated as Doctor of Science (Technol.) in 2005 from the same university. He is a member of the Editorial Board in Adsorption journal. Prof. Sainio’s research focuses on separation processes based on adsorption, ion exchange and reactive extraction. Process design methods for single and multicolumn chromatographic processes are of particular interest. The main applications of his research are in chemical conversion and chromatographic purification of plant based molecules. Another field is hydrometallurgical recovery and purification of valuable metals from primary and secondary sources.
17:00
Exploring Enhanced Selectivity of Mixed Mode Cation Exchange Resins in Bispecific and Complex Immunoglobulin Purification (IL08)
Mr Wolfgang KOEHNLEIN
F. HOFFMANN-LA ROCHE, Penzberg, Germany
Wolfgang Koehnlein graduated as a Dipl.-Ing. (FH) in Biotechnology at the University of Applied Sciences Weihenstephan in 2001 and started his work life at Roche in Penzberg. The first position included experience in the GMP environment at different scales as well as troubleshooting activities on Äkta Explorer in the small scale.
He has been in the late stage purification development since 2003 and has been involved in many collaborations with major vendors during the last 15 years. He likes to work with students and has seen many of them complete their Masters Thesis under his supervision.
He is an expert for chromatography in his department and has been working intensively on identifying proper conditions for the application of multimodal resins.
17:25
Short-Cut Design of Four-Zone Simulated Moving Bed Chromatography for Multi-Component Systems: Langmuir-Type Isotherms (OC15)
Dr Ju Weon LEE
OTTO VON GUERICKE UNIVERSITY, Magdeburg, Germany
17:45
Robustness Analysis by Predictive Distribution for Various Operating Configurations for Simulated Moving Bed Chromatography (OC16)
Mr Kensuke SUZUKI
NAGOYA UNIVERSITY, Nagoya, Japan
Kensuke Suzuki is a PhD student in the Department of Materials Process Engineering at Nagoya University, Japan. He has been working in the group of Prof. Yoshiaki Kawajiri for about five years on modeling, uncertainty quantification, and optimization of simulated moving bed chromatography processes. His research interests include pharmaceutical engineering.
18:05
Poster session 2 & Networking
19:15
20:30
Gala dinner at Monte Mar Restaurant
(subject to prior registration)