SPICA 2014
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Workshops

Two sessions of 3 workshops will be held during the afternoon of Sunday, October 5.

  Session 1 Workshop 1 Workshop 2 Workshop 3
    Chairman: Michael Schulte

 Chairman: Alessandro Butté

Chairman: Arvind Rajendran


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

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

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

  Session 2

Workshop 4

Workshop 5 Workshop 6
 

 Chairman: Eric Valery

Chairman: Jochen Strube

 Chairman: Alois Jungbauer
 

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) 

Process Design for Purification of Small Molecules and Peptides  Process Design for Purification of Biomolecules  



Workshop 1: Preparative HPLC: Phase Screening, Method Optimisation, Process Development. Troubleshooting a Preparative Chromatographic Device

Chair: Michael Schulte, Merck KGaA, Darmstadt DE
Co-speaker: Joachim Kinkel, Technical University Georg-Simon-Ohm, Nuremberg DE

Abstract
Where to start in preparative HPLC when a certain substance has to be isolated? For many of the substance to be purified by preparative HPLC a certain method and process development is needed. Either a generic method has to be developed which is able to separate a large number of substances following a certain protocol or – for production purposes – a specialized, highly optimized and economic production route has to be developed. This workshop will try to help developing a good, robust and efficient preparative HPLC method. It will show examples mainly for adsorption chromatography on silica phases and will illustrate e.g. how important the choice of the right stationary and mobile phase is and how methods developed at analytical column dimensions can be used to optimize a preparative method in different chromatographic regimes. In addition practical advice will be given how to troubleshoot a preparative HPLC-system.

Keywords: Preparative HPLC, phase screening, method development, troubleshooting, stationary and mobile phase selection

Lecturers
Michael Schulte is Director of Perfomance Materials – Emerging Businesses Energy at Merck KGaA. He did is Ph.D. work in the group of Professor Blaschke at the University of Münster, developing new chiral stationary phases. Since joining Merck in 1995 he has more than 15 years of experience in stationary phase design and process development in preparative chromatography.

Joachim Kinkel is professor at the Georg-Simon-Ohm University of Applied Sciences at Nuremberg, Germany, Faculty of Applied Chemistry. After his studies 1978 - 1984 at the University of Mainz under the supervision of Klaus Unger on packings for biochromatography, he joined R&D chromatography of E. MERCK from 1984 to 1995. During this time he was involved in the development of packings, method development and instrumentation in the field of downstream processing, chiral separations and industrial scale chromatography, with its most important part: SMB technology. Since 1995 he teaches analytical chemistry and separation technology at Nuremberg.


Workshop 2: From Development to Commercial Scale: Rules to Scale up, QbD, Regulatory, Process Validation

Chair: Alessandro Butté, ETH Zurich, CH

Abstract
In this workshop, the complex path that is connecting the choice of the appropriate purification method to the start of a production campaign is discussed. The choice of the purification process will be challenged from different perspectives, which are often enter in conflict with the classical tools to evaluate the performance of a purification, like yield, throughput. All side aspects of a purification process will be discussed, starting from tank volumes, sampling, pooling, storage conditions, hold times, waste treatment, etc., to finish with how the process fits to the rest of process and, most importantly, to the final isolation step. The problems related to process scale up will be discussed and, in particular, how to handle the passage from the early phases of a process to the commercial scale, passing through process validation. To this regard, an important part of the discussion will focus on the regulatory aspects connected to the scale up of the process, like the definition of the critical process parameters, and on how concepts like Quality by Design (QbD) can help correctly framing the scale up process and dealing with the risks associated to it. In particular, basic concepts of Design of Experiments (DoE) and Multi-Variate Data Analysis (MVDA) will be introduced.

Lecturer
Alessandro Butté received his Ph.D. in Chemical Engineering in 2000 from ETH Zurich. After a two-year post-doc at the Georgia Institute of Technology, he join the group of Prof. Morbidelli at ETH Zurich and completed his habilitation in 2008. During this period, his research activities focused on polymer engineering, production of nano-materials for protein purification (monoliths by reactive-gelation) and chromatography purifications of peptides, proteins and Mabs. In 2008, he joined Lonza as responsible for downstream activities in the sectors small molecules and peptides and as project manager. He was also involved in the pilot program to introduce Quality by Design into R&D. In 2013, he joined back ETH as senior researcher to further develop the latter concepts. He is author of more than 50 papers on international peer reviewed journals and several book chapters.


Workshop 3: Multicolumn Processes: From Historical SMB to the Latest Advances in the Purification of Biomolecules

Chair: Arvind Rajendran, University of Alberta, CA
Co-speakers: Jose P. Mota, University of Nova Lisboa, PT | Thomas Müller-Späth, ETH and Chromacon

Abstract
Multi-column (MCC) processes have become the workhorse of chromatographic separations. They are able to overcome the limitations of low throughputs and excessive solvent consumption that characterize conventional single-column processes. Despite the higher complexity as compared to single column processes, the design and operation of a MCC separations is in fact rather simple. The workshop will trace the developments in MCC starting from the classical SMB mainly used for small molecule purification and slowly progress to more recent innovations related to large-molecule purifications. The workshop will be held in three parts.
The first part aims at providing the fundamentals of the SMB technology. We will cover the basics of SMB technology: modeling, design, and optimization of SMBs; engineering issues associated to the industrial use of SMBs.
The second part covers recent advancements in multi-column chromatography. The increasing use of the SMB as a multipurpose unit in the pharmaceutical and fine chemistry industries has led to the development of novel cyclic operating schemes, some of which are substantially different from the conventional process. Broadly speaking, the new operating schemes introduce periodic modulations of selected control parameters into the operating cycle. We shall discuss concepts such as asynchronous port switching, cyclic modulation of feed concentration, time-variable manipulation of the flow rates, and solvent-gradient operation. We shall end our presentation with a discussion of the pros and cons of using SMBs with very few columns.
The final part deals with the use of multi-column chromatography for the purification of biomolecules. In the downstream processing of valuable therapeutic proteins, achieving high purity and high yield simultaneously, is a key prerequisite for the production of safe biopharmaceuticals at low and competitive costs. On the chromatography side, the use of cost-effective, non-affinity stationary phases and gradient chromatography in combination with multicolumn continuous chromatographic processes (MCSGP) presents an option for biopurifications. Advantages over batch chromatography include the possibility of simultaneous achievement of high yield and purity, a higher throughput and lower buffer consumption. We will discuss the fundamentals of these operations and discuss academic/industrial case studies.
The workshop is designed in such a way to require only a basic understanding of chromatography as a prerequisite; no previous exposure to the SMB technology is required. It will be an in-depth primer for the newcomers to the field, and it will offer a structured presentation of the MCC fundamentals to those aiming at a better understanding of the technology. The workshop will put all participants in the position to be able to follow and profit from the scientific presentations about MCC during the conference

Lecturers
Arvind Rajendran is an associate professor of chemical engineering at the University of Alberta  (Canada). He has authored more than 50 papers in the area of separation sciences. His research interests are in large-scale adsorption and chromatography. He is on the scientific committee of important scientific meetings and on the editorial boards of Chemical Engineering and Technology and Adsorption- The journal of the International Adsorption society.

Jose P. Mota is full professor of chemical and biochemical engineering at the department of chemistry of University Nova de Lisboa (Portugal). He has authored over one hundred papers in the areas of separation science and transport phenomena. He has received 8 international awards, is member of the Scientific Council of Sciences and Engineering (CCCE) of the Portuguese National Science Foundation (FCT/MCTES), and member of the Board of Directors of the International Adsorption Society (IAS).

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.


Workshop 4: 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)

Chair: Eric Valery, Novasep, FR
Co-speaker: Joachim Kinkel, Georg-Simon-Ohm University, DE

Abstract
As the evaluation of a continuous process may involve the use of experimental and theoretical tools, some may think that such a choice will obviously always be incredibly complex… It is true, that like looking at a fractal object, one can zoom in again and again and observe incredibly interesting details to fine-tune the understanding of a separation. This workshop will aim to provide a vision with a limited level of details, and give tools and keys to select between the numerous applications of chromatography. The instructors will first present the main performance drivers of preparative chromatographic separations (e.g. solubility, loadability, efficiency) and the way they define the size and production of an equipment. Then, a comparison of the different chromatographic solutions will be made through their different characteristics (i.e. physico-chemical properties, mechanical constraints…). The attendees will learn valuable information and techniques to apply in the laboratory as well as at manufacturing scale to improve their developments and production by making the right choices.

Keywords: Batch, Continuous, Low Pressure, High Pressure, SFC, Centrifugal Partition Chromatography, Countercurrent Chromatography

Lecturers
Eric Valery field of expertise is design and optimisation of chromatographic processes, batch and continuous, on HPLC for small molecules but also for Biopharmaceuticals and Food applications. Graduation background : Paris Enginering School of Chemistry and a PhD in heterogenous catalysis, he joined NovaSep in 2002 where he started to be involved in developping theoretical, simulation and optimisation tools, he is now taking care of the innovation projects.

Joachim Kinkel is professor at the Georg-Simon-Ohm University of Applied Sciences at Nuremberg, Germany, Faculty of Applied Chemistry. After his studies 1978 - 1984 at the University of Mainz under the supervision of Klaus Unger on packings for biochromatography, he joined R&D chromatography of E. MERCK from 1984 to 1995. During this time he was involved in the development of packings, method development and instrumentation in the field of downstream processing, chiral separations and industrial scale chromatography, with its most important part: SMB technology. Since 1995 he teaches analytical chemistry and separation technology at Nuremberg.


Workshop 5: Process Design for Purification of Small Molecules and Peptides

Chair: Jochen Strube, Clausthal University of Technology, DE
Co-speaker: Olivier Ludemann-Hombourger, Polypeptide Laboratoires France, FR

Abstract
This workshop is dedicated to participants, who will either attend the symposium for the first time or will come to get trained on new job tasks related to preparative chromatography.
The workshop will give an experimental and theoretical insight into basic fundamentals. Based on molecular demands, organic chemistry synthesis tasks will be described. Synthesis routes and the integration of synthesis design with intermediate purification steps will be explained. Focus will be laid on small molecules and peptides using HPLC technology, from drug development to production scale.
Some interactive simulation tutorials will be offered on batch and multi-column chromatography process design. Actual laboratory steps to determine the physical properties needed for process design will be explained.
The course intends to generate a working basis to harmonize the differing view of chemists and engineers on HPLC chromatography.

Lecturers
Jochen Strube, is Univ.-Prof. Dr.-Ing. habil. at Clausthal University of Technology, Institute for Separation and Process Technology and director of that Institute since 6 years. Before that, Jochen has worked 7 years at Bayer Technology Services AG/Leverkusen in advance and education as chemical engineer at University of Dortmund with Diploma, Dr.-Ing and Habilitation.

Olivier Ludemann-Hombourger, is the General Director of Polypeptide Laboratories France. He received his PhD in 2001 in Chemical Engineering from “Institut National Polytechnique de Lorraine” in France in collaboration with Novasep. His research activities focused on the development of new multicolumn chromatography process (Varicol) and on the development of modeling tools for process optimization. He managed the R&D activity of Novasep during 10 years, before moving to peptide manufacturing. He was the chairman of SPICA 2012 organized in Brussels.


Workshop 6: Process Design for Purification of Biomolecules

Chair: Alois Jungbauer, University of Natural Resources and Life Sciences, AT
Co-speaker: Bernt Nilsson, Lund University, SE

Abstract
Scale up of process chromatography of large biomolecules such as proteins, plasmids, virus, and virus like particles is the topic of this workshop. An introduction to the biophysical properties of these molecules will be given and consequently, which chromatographic models apply to describe the adsorption and desorption on chromatographic media. Chromatographic media most suitable for this type of molecules will be reviewed. Scale up rules will be addressed and how a chromatographic processes can be designed to reach optimal productivity and selectivity. The critical process parameters will be highlighted and mathematical models will be described to explore the range of operation. The workshop will be completed with examples from industry, showing scale-up from mg to kg and highlighting operational constraints related to industrialization.

Keywords: Protein Purification, Scale Up, Modeling, Process Design

Lecturer
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.

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.


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