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SUSTAINABLE PHARMACEUTICAL MANUFACTURING INNOVATION
SAVE THE DATE for the first CESPE Industrial Partnering Day!
December 2nd, 2.00pm – 5.00pm
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Interested in how Ghent University accelerates innovation and cultivates partnerships in Sustainable Pharmaceutical Engineering and Manufacturing? Innovating in the pharmaceutical or biotech industry? Equipment, infrastructure developer or system integrator? We gladly introduce you to CESPE and provide you with a selection of high-quality R&I pitches from both UGent and industry!
Speakers:
- UGent rector Rik Van de Walle
- Deputy mayor of the City of Ghent Sofie Bracke
- World class industry leaders: Janssen Pharmaceutica and Takeda.
Register now to receive your personal invite and program updates on the Keynote and pitching sessions!
Free of charge. Registration is closed.
End-to-end integrated pharmaceutical manufacturability of tomorrow’s medicines – Enabling sustainable innovation in drug substance and drug product production.
Thomas De Beer graduated in pharmaceutical sciences in 2002 at the Ghent University in Belgium. He obtained his PhD at the same university in 2007. For his PhD research, he examined the suitability of Raman spectroscopy as a Process Analytical Technology tool for pharmaceutical production processes. Within his PhD research period, he worked four months at University of Copenhagen in Denmark, Department of Pharmaceutics and Analytical Chemistry (Prof. Jukka Rantanen). After his PhD, he was an FWO funded post-doctoral fellow at the Ghent University (2007-2010). Within his post-doc mandate, he worked 9 months at the Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics from the Ludwig-Maximilians-University in Munich, Germany (Prof. Winter and Prof. Frieβ). In February 2010, he became professor in Process Analytics & Technology at the Faculty of Pharmaceutical Sciences from the university of Ghent. His research goals include bringing innovation pharmaceutical production processes (freeze-drying, hot-melt extrusion, continuous from-powder-to-tablet processing etc.). More specifically, Prof. De Beer contributes to the development of continuous manufacturing processes for drug products such as solids, semi-solids, liquids and biologicals (continuous freeze-drying of unit doses). Thomas De Beer is also director of Ghent University’s Center of Excellence in Sustainable Pharmaceutical Engineering (CESPE) which is founded in 2016.
Sarah Costers joined the CESPE team as project manager with expertise in discovery and development of biologics.
Sarah graduated as bioengineer cell and gene biotechnology and obtained a PhD in veterinary science in the field of virology/immunology, both at Ghent University. After 14 years of R&D in the biotech/pharma industry, she now returns to the alma mater/CESPE to facilitate and organize knowledge exchange and collaboration between industry and academia via strategic projects. She will attract additional funding for the equipment of the CESPE Innovation accelerator and incubator and provide support for the commercialization of the CESPE Innovation incubator.
Prof. Dr. Ir. Christian V. Stevens (°1965) is professor at the Department of Green Chemistry and Technology at the Faculty of Bioscience Engineering (Ghent University). He graduated at the same department as bio-engineer in chemistry in 1988 and obtainded a PhD in 1992 as fellow of the National Fund for Scientific Research. During his PhD he also worked as a research assistant of the University of Southern California (USC), Los Angeles, USA with Prof. C.E. McKenna.
After his PhD at Ghent University under the direction of Prof. N. De Kimpe, he did post-doctoral work at the Center for Heterocyclic Compounds at the University of Florida, USA under the direction of Prof. A. R. Katritzky as a NATO Research Fellow. He became group leader in the group of Prof. Katritzky in 1993. He returned as a postdoctoral fellow of the National Fund for Scientific Research. In 1994, he also made a short postdoctoral stay at the University of Alicante (Spain) under the direction of Prof. M. Yus.
In 1995, he became group leader of the National Fund for Scientific Research and became guest professor in 1997 at Ghent University. In 2000, he became professor at the current Faculty of Bioscience Engineering and developed the research group SynBioC of which he is the director. Since 2014, he is senior full professor.
His major research topics are:
- Heterocyclic Synthesis
- Microreactor Technology
- Chemical modification of Renewable Resources
Catherine S. J. Cazin received her MSc from the Université Montpellier II in 1999 and her PhD from the University of Exeter where she worked under the supervision of Robin B. Bedford on Pd-based catalytic systems. Catherine carried out a postdoctoral stay at the Universität des Saarlandes with Michael Veith and one at the Institut Français du Pétrole with Hélène Olivier-Bourbigou. She then obtained a position as Chargée de Recherche at the CNRS. She joined the EaStCHEM School of Chemistry of St Andrews in 2009 where she held a Royal Society University Research Fellowship from 2011 until 2016. She then joined the Department of Chemistry of Ghent University as a full professor. Her research interests lie in the development of sustainable synthesis through mechanochemistry (synthetic and catalytic), electrochemistry, and the design of high activity transition metal catalysts for fine chemical synthesis.
Delphine De Smedt, PhD, has a master in biomedical sciences (2006) a master in business economics (2007) an a PhD in medical sciences (2014). She started her professional career as attaché at the RIZIV/INAMI (Dienst voor geneeskundige verzorging/Le Service des soins de santé). Since august 2008, she has been working at the Ghent University, Department of Public Health and Primary Care, first as junior researcher and PhD student, later as FWO post-doctoral fellow and since 2017, as assistant professor. In January 2014, she obtained her PhD entitled ‘Health-related quality of life and psychological distress in patients with coronary heart disease’ for which she was nominated as Laureate faculty doctoral price 2013-2014.
Delphine De Smedt is experienced in health economics and epidemiology. Her main research interest are related to health-related quality of life, disease burden, disease modelling and health economic evaluations. Delphine De Smedt is national coordinator of the EUROASPIRE survey, which has the aim to assess whether the guidelines on cardiovascular prevention are being follow in clinical practice. Within this European project, she acts as principal investigator for the EUROASPIRE health economics project. Furthermore, she is the main supervisor of the QAPICHE study, which has the aim to investigate the health-related quality of life in adults with chronic diseases. Furthermore, she is activily involved in the research activities of the European Society of Cardiology.
Delphine De Smedt has extensive experience in measuring patients reported outcomes, and in cost-effectiveness analysis. She has published over 45 publications, and has an H-index=16 (ISI).
Stefaan C. De Smedt (°1967) studied pharmacy at Ghent University (Belgium) and received his MS degree in pharmaceutical sciences in 1990. He graduated from Ghent University in 1995. In 1995 he joined the pharmaceutical development group of Janssen Research Foundation. Since 1997 he has been a post-doctoral fellow of the Flemish Fund for Scientific Research at the Departments of Pharmacy of respectively Ghent University and the University of Utrecht (the Netherlands). In October 1999 he became Professor in Physical Pharmacy and Biopharmacy at Ghent University where he founded the Ghent Research Group on Nanomedicines. In 2007 Stefaan C. De Smedt was Guest Professor at the Catholic University of Leuven (Belgium) and from 2012 till 2014 he was appointed Guest Professor at the University of Antwerp (Belgium). Currently he is Guest Professor at the Shanghai Jiao Tong University (2016-2019), Distinguished Visiting Scientist of the Chinese Academy of Sciences at the University of Science and Technology of China (Hefei; 2017), and Specially Appointed Professor of Nanjing Foresty University (2016-2018). He served as dean of the Faculty of Pharmaceutical Sciences at Ghent University from 2010 till 2014. Since 2014 he is a member of the Board of Directors of Ghent University. Since 2004 Dr. De Smedt serves as the European Associate Editor of the Journal of Controlled Release (JCR), being a leading journal in Pharmacology & Pharmacy; In 2015 he became Editor of JCR (for the region Europe- the Middle East & Africa). In 2015 he has been elected as member of the Belgian Royal Academy of Medicine. In 2017 he joined the board of CRIG (cancer research institute Ghent). Dr. Stefaan De Smedt filed 15 patents on carriers (and adjuvants) for drug delivery, and materials (and methods) for diagnostics. He is a scientific founder of Memobead Technologies, a spin-off from Ghent University, whose technology was further developed by Biocartis in Lausanne (Swiss) and Mechelen (Belgium). Currently MyCartis (Ghent) commercializes the technology. Dr. De Smedt is a member of the Drug Delivery Advisory Panel of Santen (Japan) specialized in ophthalmological medicines.
I obtained a Ph.D. in Chemistry at UGent in 1988 and began an industrial career in Bekaert Technology Centre as R&D manager, process development engineer and finally global process owner wet drawing lubrication and steel cord – rubber adhesion; my main responsibility was leading Operation Excellence (OPEX) and product development projects. In this position I gained a wide experience in quality improvement tools, statistical data analysis & modelling and Design of Experiments. Achieving key process improvement projects goals I got qualified as ASQ Certified Six Sigma Black Belt by American Society for Quality. After my industrial period, as independent consultant in R&D support and Design of Experiments, I was trainer Green Belt and Lean Six Sigma in pharma industry.
Actually at HOGENT for 10 years now, I am teaching TQM, Chemometrics, applied statistics and Industrial Chemistry. My mission is to put professional experience at the service of a next generation junior engineers and managers. I am also member of the HOGENT Centre of Applied Data Science platform that provides support in data processing to a variety of industrial service and R&D projects. In the JMP User Community I participate in instructive discussions about statistical data analysis and present case studies on discovery summits.
Jo Dewulf is full professor at Ghent University, Department of Sustainable Organic Chemistry and Technology. He holds a Ph.D., M.S. and B.S. in Bioscience Engineering. He focuses on resource consumption and efficiency analysis, relying mainly on thermodynamic principles and life cycle thinking. He makes thorough analyses at the process, plant and overall industrial system level, based on life cycle thinking and thermodynamic principles in order to find out opportunities for improvement (techniques: Exergy Analysis: EA; (Exergetic )Life Cycle Analysis: (E)LCA). Apart from methodological improvements, implementations and collaborations with industrial partners have been put in practice in three areas: fine chemicals and pharma, agro/bio/food, and secondary and primary raw materials. For his work, he obtained the prize of the Laureate of the Royal Academy of Sciences and Arts of Belgium in 2008. During 2013-2015, he worked as senior scientist at the European Commissions’ Joint Research Centre on the sustainable use of natural resources including resource efficiency, criticality, supply resilience, etc. His work is visible on the international scene, with more than 230 papers in international peer reviewed journals included in the Web of Science (Science Citation Index Expanded only), with about 6000 citations and an h-index of 42. He assisted to several international conference organisations and international journals, e.g. serving at the RCR editorial board.
Richard Hoogenboom (1978) studied chemical engineering at the Eindhoven University of Technology (the Netherlands). In 2005, he obtained his Ph.D. under the supervision of Ulrich S. Schubert and continued working as a project leader for the Dutch Polymer Institute. After postdoctoral training with Martin Moeller and Roeland Nolte, he was appointed as associate professor at Ghent University in 2010 and in October 2014 he was promoted to full professor. His research interests include stimuli-responsive polymers, supramolecular polymers, and poly(2-oxazoline)s. He has published > 400 scientific articles and is currently editor-in-chief for European Polymer Journal and associate editor for Australian Journal of Chemistry. Prof. Hoogenboom is the recipient of the inaugural Polymer Chemistry Lectureship (2015), the fifth PI IUPAC award (2016) and the ACS Macromolecules/Biomacromolecules young investigator award (2017).
Jeroen Lauwaert is an assistant professor in sustainable industrial chemistry at the Industrial Catalysis and Adsorption Technology research group of Ghent University, since September 2021. He started his doctoral research, on the design of cooperative acid-base catalysts for aldol reactions, at the Laboratory for Chemical Technology (LCT) in collaboration with the Center for Ordered Materials, Organometallics and Catalysis (COMOC) at the same university, in 2011. In 2014, he gained international experience while working in the group of prof. Jones in Atlanta, USA. Following the completion of his PhD in 2015, he joined Ghent University’s Industrial Catalysis and Adsorption Technology (INCAT) research group as a postdoctoral assistant. In 2017 and 2020, his expertise in the broad field of chemical engineering, ranging from heterogenous catalysis and reaction engineering to thermodynamics and separation train design, was honored by FWO (Research Foundation – Flanders) with, respectively, a junior and a senior postdoctoral fellowship. In 2021, he was appointed as part-time (50%) assistant professor.
Today, prof. Lauwaert supervises 10 young researchers who primarily focus on process intensification for applications spanning from biomass valorisation to fine chemical and pharmaceutical industries. His research activities comprise a wide spectrum of fields.
One of the major themes is heterogeneous catalysis and reaction engineering, which involves synthesizing and characterizing catalysts and testing their performance in terms of activity, selectivity, and stability. Additionally, he develops intrinsic kinetic and industrial reactor models to optimize reaction conditions and design catalysts.
Secondly, prof. Lauwaert has expertise in adsorption technologies for the recovery of high value components that are present in low concentrations in waste streams. Furthermore, he aims to unravel the thermodynamics of molecules containing multiple functionalities and/or heteroatoms by developing thermodynamic models that can be applied to separation train design. Finally, a minor research topic of prof. Lauwaert aims at developing multidimensional chromatographic analysis techniques (liquid and gas) for complex mixtures, e.g., non-volatile aromatics.
Prof. Dr. ir. Clara Mihaela Ionescu is docent at the Faculty of Engineering and Architecture, Dynamical Systems and Control research laboratory. She has 15 years expertise in process control, both in basic and advanced control strategies applied to chemical processes and manufacturing plants. Her know-how varies from fundamental control algorithms to hands on control tuning for non-control-specialised process operators. Her interests are in the pragmatic development of tools from control engineering area to the deployment thereof at the core of the production units. Specific challenges addressed in the past included: variable time delays, plant mismatch, multiple objective optimization in real time (with priorities) and sub-process interaction (train of process subunits). Specific control methodologies include: PID type, robust compensators design, predictive control and automatic tuning based on changes in operating point or product specification. She has an h-index of 22 in Web of Science with about 100 peer reviewed published articles.
Steven P. Nolan was born in Québec City. He obtained his B.Sc. from the University of West Florida in 1983 before moving to the University of Miami to work with Prof. Carl Hoff on the thermochemistry of organometallic compounds. After a postdoctoral stay with Prof. Tobin J. Marks at Northwestern University, he joined the University of New Orleans in 1990 rapidly raising to the rank of University Research Professor in 1999. In 2006 he joined the Institute of Chemical Research of Catalonia (ICIQ). In early 2009, he moved to the School of Chemistry at the University of St Andrews in Scotland and in 2017 moved to his present position in the Department of Chemistry of Ghent University as Senior Full Professor.
Professor Nolan’s work has been recognised with numerous awards such as the recent A. C. Cope Scholar award from the ACS (2023) along with various other recognitions such an an ERC advanced grant and election to learned Societies. He is Fellow of the Royal Society of Canada, the Royal Society of Edinburgh and the European Academy of Sciences.
Steve has published 3 monographs and over 680 research papers. His work has a H-index of 120.
Professor Nolan’s research interests revolve around the design and synthesis of catalytic complexes enabling organic transformations.
Joris W. Thybaut (°1975, Ghent Belgium) is full professor in catalytic reaction engineering at the Laboratory for Chemical Technology at Ghent University since October 2014. He obtained his master’s degree in chemical engineering in 1998 at the same university, where he continued his PhD studies on single-event microkinetic (SEMK) modeling of hydrocracking and hydrogenation. In 2003 he went to the ‘Institut des Recherches sur la Catalyse’ in Lyon, France, for a postdoc on high throughput experimentation, before being appointed in 2005 at Ghent University.
Today, prof. Thybaut is heading the Catalytic Reaction Engineering (CaRE) research group, comprising about 15 junior researchers and post-docs, within the Laboratory for Chemical Technology at Ghent University. Prof. Thybaut and his group actively investigate a variety of large-scale industrial reactions and more particularly, the rational design of the corresponding catalysts as well as of the reactors in which the corresponding reactions are exploited. Ideal gas phase reactions as well as strongly non-ideal liquid phase reactions are addressed. Research projects range from bilateral contracts with industry up to government funded large scale integrated projects. Prof. Thybaut holds an ERC consolidator grant to innovate the SEMK methodology and use it in the framework of renewable, oxygen containing feeds. More recently, as part of bilateral collaborations the scope of the investigated chemistry is further being extended towards inorganic reactions. Major efforts also go into VOC elimination using various oxidizing agents and conditions.
Chris Vervaet is a pharmacist and obtained his PhD in Pharmaceutical Sciences at Ghent University in 1997. After a post-doc in the Aerosol Research Group at the Virginia Commonwealth University (Richmond, Virginia, US) he was appointed in 2000 as professor at the Department of Pharmaceutics (Faculty of Pharmaceutical Sciences, Ghent University). Since 2013 he is chair of the Department of Pharmaceutics, and since 2015 he is director of the Laboratory of Pharmaceutical technology. His research focuses on drug delivery, more specifically on the development of innovative solid dosage forms for oral applications. His fields of expertise are drug compounding, pharmaceutical technology, sustained drug release, continuous manufacturing, granulation/tableting, hot-melt extrusion and extrusion/spheronisation. His research intensively collaborates with equipment manufacturers as well as pharmaceutical companies for the introduction of continuous manufacturing within the pharmaceutical industry, e.g. continuous wet granulation, continuous feeding/blending, continuous freeze drying. The department is affiliated with several international research clusters, e.g. the Pharmaceutical Solid State Research Cluster (with partners from Helsinki, Lille, Leuven, Dusseldorf, Cambridge, Graz, Otago, Lisbon, Ljubljana and Copenhagen) and the Interreg IMODE cluster (with members of Lille, East Anglia, London, Greenwich and Cambridge). He has supervised 38 PhD students (since 2000), published about 260 internationally peer reviewed articles and 8 books chapters, and has filed 19 patent applications. He is member of the board of the Belgian Society of Pharmaceutical Sciences (since 2013), and is on the editorial board of the Journal of Drug Delivery Science and Technology and the International Journal of Pharmaceutics.
In 2018, Jan Verwaeren became associate professor at Ghent University and member of the research unit on Knowledge-based systems (KERMIT, https://kermit.ugent.be/). As a computer scientist, his research interests lies on the crossroads between machine learning, mathematical optimization and image processing. His expertise include methodological and algorithmic development as well as applied research in these areas.
From a methodological point of view, he likes to combine novel insights from the fields of convex and discrete optimization to develop new data analysis strategies for solving predictive modelling, data-reduction and image processing problems. From an application point of view, through collaborations with research units and companies in pharmaceutical engineering, he is currently active in model driven experimental design (active learning) for pharmaceutical product formulation and model-driven predictive maintenance in pharmaceutical production facilities. In the (broader) field of applied biological sciences, he works on projects related to the use of image processing techniques for plant phenotyping, food processing and precision livestock farming.
Prof. dr. Paul Van Liedekerke is assistent professor at Ghent University. He holds a MSC in physics (University of Ghent), a PhD in bio-engineering (KULeuven) and a Habilitation from Sorbonne University, Paris.
Paul has worked at KULeuven (2001-2011) where has developed Discrete Element Methods to simulate granular flows in machinery, as well as Computation Fluids dynamics methods to simulate complex fluids. From 2012 to 2022 he worked at INRIA de Paris as expert engineer where he created models and software to predict cellular growth (in vitro and in-vivo) and living tissue development. During these years he collaborated with industrial partners on several occasions.
His interests and expertise lie in developing numerical models and new conceptual ideas such as hybrid modelling and digital twins, and applying those techniques in industry and medicine. In a nutshell: simulations of granular flow and powders, simulations of cell growth and living tissues, simulations of bioreactors: cell yield and biologics, and software development.
Kevin Van Geem (full professor) is member of the Laboratory for Chemical Technology of Ghent University and director of the Center for Sustainable Chemistry. Thermochemical reaction engineering in general and in particular the transition from fossil to renewable resources are his main research interests. He is a former Fulbright Research Scholar of MIT, visiting professor of Stanford and coordinates the experiments on more than a dozen pilot plant an d bench scale units. He is the author of more than two hundred scientific publications and has recently started his own spin-off company. He is involved in on-line and off-line analysis of complex petrochemical and biochemical samples using comprehensive two-dimensional gas chromatography. Artificial intelligence, first principle model development, scale-up, and process intensification belong to his main expertise. He is currently the coordinator of 3 different large-scale projects: IMPROOF (SPIRE H2020, Scientific coordinator 2016-2020), OPTIMA (ERC consolidator, Scientific coordinator, 2019-2024), WATCH (Catalisti, Scientific coordinator 2019-2023).
Categories
DySC
Field of Expertise:Modelling, process control, identification, multi-objective process optimization, multivariable control
The Dynamical Systems and Control (DySC) group has research expertise on modelling and control of dynamical systems in several application fields from biomedical to industrial processes.
In the last years the group of Prof. Ionescu has focused on the application of fractional order control as an intermediate control strategy for industry and manufacturing processes, between basic control (such as PID type) and advanced control (such as MPC). Part of this scope is the industrial relevant implementations of MPC and multi-objective optimization algorithms as a function of changing operating context.
Furthermore, there is an ongoing ERC Consolidator grant focusing on the use of computer based constrained optimization of multi-drug infusion rates for anesthesia with strong effects on hemodynamics.
As current topics, the DySC group focusses on modelling and control of dynamical systems with application fields in:
- Biomedical
- Chemical
- Pharmaceutical
- Mechanical
- …
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Epidemiology of Chronic Diseases
Field of Expertise:Burden of disease, patient-reported health outcomes, health economic techniques
The Epidemiology of Chronic Diseases Research Unit conducts several research projects relating to disease prevention and burden including risk factors epidemiology, lifestyle changes, risk management, physical activity at work and psychosocial risk factors.
The Unit is in close collaboration with the Belgian institute for health Sciensano (Brussels), the National Research Centre for the Working Environment Copenhagen, Jožef Stefan Institute Ljubljana, Imperial College London, Karolinska Institute Stockholm and University of Galway, with whom it shares several projects on the epidemiology and prevention of major health problems in developed and developing countries.
Within the faculty of Medicine and Health sciences, the department of Public Health and Primary Care is internationally renowned for its research in health economics and epidemiology. The research of Prof. Delphine De Smedt, associate Professor, is mainly focused on the burden of disease, patient-reported health outcomes and health economic techniques. She has experience in developing health economics models in different chronic disease areas.
Categories
INCAT
Field of Expertise:Heterogeneous catalysis, reaction engineering, adsorption technology, thermodynamics, separation train design, applied multidimensional chromatography
The Industrial Catalysis and Adsorption Technology research group (INCAT) is part of the Materials, Textiles, and Chemical Engineering department (MaTCh, EA11) within the Faculty of Engineering and Architecture at Ghent University. INCAT primarily focuses on the development of catalysts and adsorbents, with a strong emphasis on renewable resources and environmental management. A major objective is the catalytic conversion of biomass-derived streams, encompassing their upgrading and separation into valuable chemicals. INCAT’s research endeavours have a practical, application-oriented approach, addressing the specific needs of industries. To achieve this, the group actively collaborates with consortiums and industrial partners, including small and medium-sized companies in the broader chemical industry.
INCAT encompasses a diverse range of expertise across various chemical engineering domains. INCAT specializes in heterogeneous catalysis and reaction engineering, involving the synthesis, characterization, and performance testing of catalysts, as well as developing intrinsic kinetic and industrial reactor models to optimize reaction conditions and design efficient catalysts.
The research group also has extensive knowledge in adsorption technologies and focusses on developing methods to recover high-value components from waste streams that are present in low concentrations. By designing and implementing efficient adsorbents and recovery techniques, INCAT contributes to sustainable resource management.
Thermodynamics and separation train design also form an essential part of INCAT’s expertise, as the group delves into the thermodynamics of molecules containing multiple functionalities and/or heteroatoms, creating thermodynamic models that aid in the design of effective separation trains for various chemical processes.
Additionally, INCAT explores the development of multidimensional chromatographic analysis techniques, encompassing both liquid and gas phases to enable the analysis of complex mixtures, such as non-volatile aromatics, providing valuable insights for various applications.
The Laboratory for Chemical Technology (LCT) integrates chemical science and engineering in its research on catalysis, polymerization, kinetics, reactor design and process design. LCT is part of the Department of Materials, Textiles and Chemical Engineering within the Faculty of Engineering and Architecture at Ghent University in Belgium. LCT aims at research excellence and bottom-up innovation in the framework of technological, industrial, and societal challenges.
The research within LCT is based around six themes:
- Polymer design: This research theme specifically aims at the design of new polymeric materials up to industrial scale, considering advanced multi-scale computational tools. Our goal is to take control over the entire microstructure of individual polymer chains, taking into account economic and environmental constraints.
- Catalyst design: This research theme aims at the full exploitation of existing reactor technologies and the development of new reactor technologies. Main focus is on the study of the delicate interplay between reaction kinetics and mass, energy and momentum exchange phenomena.
- Reactor engineering: This research theme aims at the full exploitation of existing reactor technologies and the development of new reactor technologies. Main focus is on the study of the delicate interplay between reaction kinetics and mass, energy and momentum exchange phenomena. Given the large scale of most commercial chemical processes, the smallest improvement in reactor design has a huge impact on the use of resources and the operating costs.
- Circular process design: Today we must consider the whole lifecycle of our resources. Fundamental changes are needed in all these parts of the process industry, in particular in the design of these processes where exergy analysis, resource efficiency and life cycle analysis are fed by fundamental process simulation data that account accurately for the important chemical and physical phenomena on different scales.
- Low carbon technology: The transition from a raw material base towards an almost carbon neutral economy is one of the biggest challenges. Catalysis is a key enabling factor to allow the development of new sustainable processes and technologies and thus plays a critical role to realize transition from a linear to a circular economy. Consequently, the development of catalysts and related catalytic technologies for the use of CO2 to produce chemicals and fuels, and renewable energy in chemical production is becoming a key area.
- Renewable chemicals and technology: In this research theme, emphasis is on the development of fundamental so-called microkinetic models together with dedicated ab initio calculations and elaborate catalyst characterization to enable this extension. The individual phenomena investigated range from the chemical kinetics, over mass and heat transport phenomena and phase/thermodynamic effects, to non-ideal reactor hydrodynamics.
Categories
Laboratory of General Biochemistry and Physical Pharmacy
Field of Expertise:Nanomedicines, biopharmacy
Currently the Laboratory of General Biochemistry & Physical Pharmacy houses 4 closely collaborating research groups: the Biophotonic Research Group, the Ocular Delivery Group, the Lung Delivery Group and the Vaccine Delivery Group. The global research focus of our teams is on the delivery of bio-therapeutics, especially nucleic acids. Our teams offer a multifaceted portfolio of competencies including pharmacology, material knowledge and expertise in drug delivery, nanotechnology, cell biology, immunology, biophysics, optics and bio-photonics.
- Biophotonics Research Group: Research of this team is as aimed at the development of biophotonics-based technologies to (i) study the biophysical behavior of nanomedicines in cells and tissues and (ii) enable more efficient drug delivery. With regard to the former, the Biophotonics Research Team has specialized in the development of advanced light microscopy methods and their application to study the interaction of nanomedicines with biological barriers.
- Ocular Delivery Group: This group is highly experienced in developing (and using) in vitro, ex vivo and in vivo models for the evaluation of non-viral nucleic acid delivery to the retina. This team recently developed an ex vivo retinal explant from bovine eyes which keeps the vitreous and inner limiting membrane (ILM) intact during dissection. This allows to evaluate the potential of intravitreally injected nanoparticles to deliver therapeutics to the retina.
- Lung Delivery Group: The Lung Delivery Group mainly focuses on exploring novel ‘bio-inspired’ approaches for the delivery of nucleic acids. A major aim of this team is to develop innovative strategies to stimulate cytosolic delivery of nucleic acids in lung-related target cells for the treatment of pulmonary pathologies with a clear unmet medical need, including obstructive lung diseases and respiratory infections. To reach this goal, the team focuses on (i) exploiting endogenous materials for drug delivery, such as pulmonary surfactant, (ii) repurposing of small molecular drugs as adjuvants to promote nucleic acid delivery and (iii) improving nanomedicine design for in vivo use.
- Vaccine Delivery Group: Research projects of the Vaccine Delivery Group are situated at the interface of drug delivery and immunology. As such, we explore the potential of nanotechnology or physical approaches (ultrasound) to manipulate the immune system.
The Laboratory of Pharmaceutical Process Analytical Technology (LPPAT) focuses on the implementation of PAT systems in innovative pharmaceutical production processes and therefore has always worked in close collaboration with the Laboratory of Pharmaceutical Technology of Prof. Dr. C. Vervaet and is part of the QbD and PAT Sciences Network.
Manufacturing processes of interest:
- Freeze-drying
- Continuous wet granulation
- Production of solid oral dosage forms
- Continuous melt granulation
Implementation of PAT systems:
- The development and implementation of process analyzers in the process stream allowing real-time collection of critical process and (intermediate) product information.
- Data-analysis methods (chemometrics) allowing to extract useful information from the large datasets that process analyzers supply. Process analyzers are only valuable if they provide the desired information with sufficient accuracy. Being able to build accurate and robust models to reliably translate the data (e.g., obtained spectra) into process or product knowledge is crucial.
- Design of Experiments (DoE) to maximize the information content from experimental series while keeping the number of experiments low. As the process (step) endpoints and the intermediate or end product properties (e.g., product solid state, chemical properties, physical properties,…) are influenced by numerous process and formulation variables, appropriate experimental design approaches must be applied to find out which variables and variable interactions significantly influence processes and product properties.
- Statistical process control and visualization: a final aim of implementing PAT systems in pharmaceutical production processes is complete process control. Based on process knowledge and process models, the information obtained in real-time should be used for guiding the process to its desired state, possibly allowing real-time release. Early warnings should be given when a process is moving into an unwanted direction and the process models should allow to determine how process settings must be adapted by operators to lead the process to its desired state, thereby reducing batch rejection.
- Mechanistic modelling: empirical modelling is based on historical data and as such they are of limited use in new applications outside the experimental space studied. Apart from cause-and-effect between variables, not much else is required in terms of process knowledge. Mechanistic modelling is based on the fundamental understanding of the underlying physics and chemistry governing the behaviour of the process. Hence, mechanistic modelling does not require much data for model development, and hence is not subject to the idiosyncrasies in data. Mechanistic modelling forces to fundamentally and completely understand processes. The different steps of mechanistic modelling are mentioned in appendix. This new approach of modelling of pharmaceutical processes should allow making useful process simulations and process predictions.
The research at the Laboratory of Pharmaceutical Technology (Ghent University) focuses on the development of innovative drug dosage forms (mainly solid dosage forms) for human application as well as for veterinary use. These dosage forms are based on pharmaceutical accepted excipients used as such or as mixtures to impart specific drug release properties (immediate, controlled or sustained release) to the formulation. The lab has a strong research focus on continuous manufacturing techniques.
The projects at the Laboratory of Pharmaceutical Technology are focused on the following topics:
- Granulation: Current research mainly focusses on process and formulation development for twin screw wet and melt granulation as well as their downstream processes. Therefore, evaluating the interplay between raw material properties and process settings is of high interest. This approach is used to (i) derive preferred excipients platforms for novel APIs, (ii), evaluate the impact of batch-to-batch variability and (iii) evaluate the applicability of botch conventional and non-conventional excipients for continuous processing.
- Tabletting: Ongoing work investigates the influence of raw material and blend properties on the die-filling and tabletability during continuous manufacturing. Residence time distributions in the feedframe and influence of different process parameters are being studied. In addition, the influence of feeding and blending during continuous direct compression on the tablet content uniformity is evaluated.
- Compaction simulation: Currently, our team is working on the evaluation of the external lubrication system on the compaction simulator (Styl’One Evolution). In addition, the correlation between the tableting process and tablet quality of tablets produced on the Styl’One Evolution tableting instrument and Modul™ P rotary tablet press is studied.
- Hot-melt extrusion and 3D-printing: Hot melt extrusion is used for designing sustained release dosage forms using conventional and non-conventional polymeric materials for controlled drug release. On the other hand, the extrusion process is used to enhance the bioavailability of poorly soluble drugs by preparing molecular dispersions for immediate release dosage forms. The development of personalized 3D dosage forms with versatile release profiles is also one of our research interests. Recently, FDM 3D printing was used as an alternative HME downstream processing technique to produce personalised medicines for the manufacturing of high drug loaded dosage forms, hence offering a lot of formulation freedom for the on-demand production of personalized dosage forms at the point-of-care.
- Spray-drying: Research on the spray dryers is focussed on formulation of particles for dry powder inhalation, co-processing to obtain particles with the desired properties (e.g. improved compressibility, flowability) and creation of micro-particles for oral antigen delivery.
- Freeze-drying: Our lab developed a continuous freeze-drying process in collaboration with the Laboratory of Pharmaceutical Process Analytical Technology. This continuous freeze-drying concept is based on spinning the vials during freezing (I.e. spin-freezing) and on non-contact energy transfer via infrared radiation during drying. This improves process efficiency and product uniformity compared to conventional batch drying. Our research focus is development of a formulation strategy and optimisation of the models used in the different steps of continuous freeze-drying.
Categories
Supramolecular Chemistry Group
Field of Expertise:Polymer chemistry and polymer materials
The research of the Supramolecular Chemistry Group (Ghent University) focuses on the molecular design of polymer materials for a broad range of applications, including drug delivery, biomaterials and excipients. The group has a strong expertise in the synthesis of defined (functional) polymer structures with a special emphasis on poly(2-oxazoline)s, responsive polymers and supramolecular materials.
Some illustrative examples of relevant projects are listed below:
- Poly(2-oxazoline) matrix excipients for oral dosage forms enabling high drug loading (up to 70%-80) amorphous solid dispersions of poorly water-soluble drugs, such as flubendazole, mebendazole and fenofibrate
- Poly(2-oxazoline) matrix excipients for oral dosage forms enabling high drug loading (up to 70%) sustained release formulations of drugs with good water solubility, such as metoprolol tartrate and metformin
- Cationic polymers for transfection of pDNA, siRNA, mRNA and saRNA enabling better in vitro transfection than lipofectamine and similar in vivo transfection as lipid nanoparticles
- Polymer-drug conjugates to reduce systemic toxicity and enhance blood circulation time, possibly in combination with targeting ligands, including antibody-drug conjugates
- Polymer-protein conjugates to enhance blood circulation time and enhance protein stability
- Responsive polymers that are insoluble in the blood stream but rapidly solubilize upon cell internalization, through either protonation or degradation of side chains under mild acidic conditions
The Synthesis, Bioresources and Bioorganic Chemistry (SynBioC) Research Group is active in the broad field of organic synthesis with projects ranging from the synthesis of new bioactive compounds for applications in the medicinal and the agrochemical field, the isolation and study of natural products, the use and chemical modification of renewable resources, to the implementation of green chemistry, microreactor technology and photo chemistry.
Within the framework of organic and bioorganic chemistry, the following research lines are elaborated:
- The chemistry of small-ring azaheterocycles: This research involves the study of regio- and stereoselective ring transformations of constrained (phosphonylated) azaheterocycles such as aziridines, azetidines and beta-lactams. Next to the fundamental aspect of designing and evaluating new synthetic methods, the application of these techniques is also employed for the construction of a broad variety of heterocyclic target compounds with biological interest (diversity-oriented approach).
- Synthesis of bioactive substances: Several projects are focused on the synthesis of specific classes of natural product analogues (e.g. curcuminoids, quorum sensing signaling compounds) and other new compounds associated with certain biological activities (target-directed approach). Examples include the synthesis of anticancer agents, antibiotics, antimalarials, analgetics, HDAC-inhibitors, crop protection products,…
- Green chemistry and renewable resources: Renewable chemicals and materials are currently a hot topic in research and industry. The depletion of fossil resources and the exhaust of greenhouse gases force us to think about alternative sources for the chemical industry and the energy sector..Our research group focuses on the modification of non-fossil resources towards renewable chemicals, such as the modicification of biopolymers (inulin, chitosan), the use of 10-undecenoic acid (derived from castor oil) and the production of biofuels and renewable fuel additives.
- Microreactor technology: Microreactor technology (MRT) provides a number of specific advantages compared to batch processes: it is often more selective and efficient, has a better mass and heat transfer capacity, consumes often less reagents and solvents, has good safety features and allows to work with very reactive and/or toxic reagents. The SynBioC research group is active in the application of microreactor technology for multicomponent reactions, reactions using dangerous reagents, fotochemical and low temperature reactions.
Fascinated by pharmaceutical process development and how novel drug manufacturing techniques contribute to that? Eager to pursue a PhD in Pharmaceutical Sciences on the industrial implementation of continuous tablet manufacturing via direct compression?
This could be your opportunity! A collaboration between Ghent University CESPE and Johnson and Johnson Belgium!
More information on the topic and how to apply on the UGent Job portal!
Short project description
The pharmaceutical industry is switching from batch-wise to continuous manufacturing of tablets. The aim of current project is to address crucial gaps of knowledge for industrial implementation of continuous tablet manufacturing via direct compression.
During drug product development limited amounts of new chemical entities are available to investigate the effect of formulation and process variables on the final drug product. The first aim is therefore to develop a strategy for identification of a surrogate component, i.e. a component with similar characteristics as the new chemical entity, to use during early process and formulation development trials. Furthermore, continuous feeding of very cohesive raw materials is often challenging and affects further downstream processing. Therefore, various formulation strategies to overcome feeding issues of very cohesive raw materials in function of process parameters will be developed. Finally, a control strategy based on residence time distributions is of utmost importance to ensure the final product quality and traceability along the manufacturing line. Therefore, the critical formulation and process parameters affecting residence time distributions on a continuous direct compression line will be investigated and predictive models will be built for each unit operation and for the integrated line.
Interested in the capabilities of continuous freeze-drying? What is the impact on stability, supply chain, manufacturing operations, quality control, etc.?
Subscribe to the hands-on workshop on batch versus continuous freeze-drying of pharmaceuticals!
- Demonstration of continuous freeze-drying prototypeF
- Formulation characterization for batch and continuous freeze-drying hands-on training
- DEMO PAT for continuous freeze-drying
- Dynamic design space determination
- Execution of batch and continuous freeze-drying processes for selected formulations
- Evaluation performed batch and continuous freeze drying runs
- Determination CQAs freeze-dried products: batch versus continuous
CESPE will present to you at Knowledge for Growth 2018 this week Thursday 17th in Ghent #KfG2018! Visit us at exhibition booth 75, first floor of TTO Flanders Ghent University Tech Transfer to get to know more about the Centre of Excellence in Sustainable Pharmaceutical Engineering. #KfG2018 with flanders.bio. https://www.knowledgeforgrowth.be/