We are pleased to announce that registrations for the CESPE conference on Manufracturing Innovations for a Sustainable (Bio)Pharmaceutical Industry have been opened.
For information on sponsorships and exhibition booths, as well as general questions considering the conference and CESPE, feel free to contact Dr. Christoph Portier (Christoph.Portier@UGent.be) or Dr. Wouter De Soete (Wouter.DeSoete@UGent.be).
CESPE is pleased to announce its yearly conference on Thursday September 15, 2022 focusing on Manufacturing Innovations for a Sustainable (Bio)Pharmaceutical Industry. This event will cover both drug substance and drug product manufacturing innovations, demonstrating the position of Flanders and Belgium as global leaders in (bio)pharmaceutical manufacturing. During this physical event in Ghent, you will have the opportunity to network with our academic members, industrial partners and policy makers. Therefore, this event is perfectly suited for senior scientists, industrial decision makers and policy makers active within the ecosystem.
Stay tuned for more information on the program and registration!
2 PhD Positions to develop a Predictive Framework enabling Real-Time Release Testing in Solid Dosage Manufacturing
Overview
This PhD project aims to develop a knowledge-based predictive framework for dissolution testing to enable real-time release testing (RTRt) in solid dosage manufacturing. The research will be conducted in close cooperation with pharmaceutical companies and the UGent research accelerator Centre of Excellence in Sustainable Pharmaceutical Engineering and Manufacturing (CESPE). The research outcome will be published in important scientific journals.
Traditionally, RTRt frameworks are developed by individual companies and partnering research institutions leading to a costly and resource-intensive process. Moreover, the development requires a thorough process understanding as well as controls embedded in the production processes. In this project, a predictive framework for dissolution testing will be developed using material, process, and PAT data from continuous direct compression process. This project presents a unique opportunity to work at the academia-industry interface on a very important and relevant topic to the pharmaceutical industry. A range of formulations and knowledge from multiple pharmaceutical companies involved in the project will lead to development of a generic and better predictive framework enabling RTRt.
The project currently has two open positions for PhD candidates: a PhD project with an Experimental focus and a PhD project with a mathematical modeling focus. The researcher with an experimental focus will get an in-depth scientific understanding, hands-on experience of direct compression based manufacturing and gain expertise in practical aspects of dissolution test development applicable to an industrial working environment. The researcher with a modeling focus will apply different modeling approaches of developing in vitro predictive dissolution models based on product and process understanding. Hence, a predictive dissolution modeling framework will be developed to support product development within the space explored during formulation and process optimization and as surrogate tests in a regulatory filing towards RTRt.
Profiles
Experimental research focus:
Master’s degree in pharmaceutical sciences, physical chemistry, or a related discipline
Experience in dissolution testing of pharmaceutical dosage forms.
Experience with various analytical techniques (DSC, XRD, IR, TGA, DVS, HPLC).
Experience in multivariate data analysis is desirable.
Mathematical modeling research focus:
Master’s degree in bioengineering, chemical engineering, and process engineering or a related discipline
Experience with the development of numerical methods
Experience with mechanistic and data-driven modeling methodologies
Experience in Python and/or MATLAB is desirable.
Candidates must have a strong interest in both experiments and theoretical modeling
More information For further information, please contact:
You have to use the online application tool available here or by sending an email to Ashish.Kumar@UGent.be to provide your CV with names of three references, motivation letter and transcripts of your bachelor and master studies.
Application deadline and start date
The position is available immediately and will remain open until it is filled. While the start date is flexible, the target is to start from Feb 2022.
2 PhD positions in Pharmaceutical Manufacturing Innovation with Focus on Continuous Pharmaceutical Freeze-Drying
Overview
The general goal of these PhD research projects is to further innovate in a continuous freeze-drying technology for (bio)pharmaceuticals and explore its potential as an enabler for different pharmaceutical products.
Topic 1: The evaluation of different energy supply systems for the continuous & controlled (mechanistic based) freeze-drying of biopharmaceutical unit doses.
Topic 2: Continuous freeze-drying as an enabling technology for different types of pharmaceutical products (e.g., lipid nano-particle based products, highly concentrated protein formulations, vaccines, cold chain distributed products, etc.) The research projects may be conducted in close cooperation between Ghent University (Belgium) and pharmaceutical companies and equipment manufacturers. The PhD project will be executed in Ghent, Belgium. The research outcome will be published in important scientific journals.
Profile
Master’s degree in Pharmaceutical Drug Development, Industrial Pharmacy, Pharmaceutical Engineering, Bio-science Engineering, Chemical Engineering or a related discipline.
Experience with pharmaceutical technology is desirable.
Candidates must have a strong interest in biopharmaceutical product development manufacturing innovation, analysis and data-analysis.
Pharmaceutical Process Analytics & Technology research group (Ghent University) Faculty of Pharmaceutical Sciences Prof. Dr. T. De Beer – Thomas.DeBeer@UGent.be – +32-9-2648097
How to apply
Please send your CV with names of three references, motivation letter and transcripts of your bachelor and master studies to Thomas.DeBeer@UGent.be
Belgium has an excellent position in the development of new medicines. ‘To continue to play that leading role, we also need to focus on innovation in drug production,’ says Professor Thomas De Beer.
With the CESPE Innovation Accelerator, Ghent University offers an answer to the need for top research infrastructure for innovation in pharmaceutical production technology. This is necessary to further anchor Belgium’s leading position in the field of drug development research and to guarantee its production in our region.
Need for innovation in pharmaceutical production
‘If you look at pharmaceutical manufacturing innovation over the last decades, it hasn’t kept up with the speed of drug development. Innovation in the pharmaceutical sector primarily focuses on the development of medicines. But the increasing complexity of medicines and their supply needs also requires innovation in production technology,’ says Professor Thomas De Beer. He is director of CESPE, the Center of Excellence for Sustainable Pharmaceutical Engineering & Manufacturing at Ghent University, which is the basis of the new innovation accelerator for production technology in the pharmaceutical sector.
‘Innovation in the pharmaceutical sector primarily focuses on the development of medicines. But the increasing complexity of medicines and their supply needs also requires innovation in production technology.’ Professor Thomas De Beer.
‘Unlike other sectors in the manufacturing industry, pharmaceutical products are often developed before it is clear how they can be produced on a large scale in a competitive, sustainable and flexible way. By linking the development of a medicine at an early stage to the development of the production process, you shorten the lead time,’ explains Professor De Beer.
‘The Corona pandemic has also increased the need for agile production technologies. Just think of the supply of intermediate substances in the event of an abruptly rising demand or local production of critical medicines, and the associated cold chain distribution at -80°C of certain vaccines. This requires new technologies and we will research and develop them in the new CESPE center in collaboration with the industry,’ says Wouter De Soete, manager of CESPE at Ghent University.
Unique research infrastructure
The CESPE Innovation Accelerator will include cleanrooms, lab and office space as well as a (bio)pharmtech incubator. ‘This combination of research infrastructure in the field of production innovation is unique in Belgium. With this we make a huge difference, not only for academic research but also for industry,’ emphasizes Professor De Beer.
‘This research infrastructure in the field of production innovation is unique in Belgium. With this we make a huge difference, not only for academic research but also for industry.’ Professor De Beer.
There are strict requirements for the production of medicines. You have to create the right conditions for researchers and for the products you work with. Thanks to the modular and flexible layout of the cleanrooms and lab areas, large companies, start-ups and research institutions can perform tests and collaborate under optimal conditions. This is the only way to create the right environment for innovation.’
The center also provides the necessary space to accommodate spin-offs resulting from this innovative research. ‘We strongly believe that cross-fertilization between industry and academia will lead to innovative production technologies. In the field of production technology within the pharmaceutical sector, we want to become the reference point, both for research and training of the right profiles. For that reason, we will start with a new master in pharmaceutical engineering in the academic year 2022-2023. This combination of pharmaceutical and engineering skills is much needed in the sector to realize innovation. By focusing on that, we are firmly convinced that this will lead to new start-ups. We also want to offer them the necessary support in the CESPE center to start up and grow.’
‘The main goal of CESPE is to be the leading innovation hub in Europe for the end-to-end pharmaceutical production of tomorrow’s medicines,’ according to Wouter De Soete. ‘That means that we examine the entire drug production chain, from development to its supply to the market, and examine how we can model and optimize it as best as possible. For this we have to call on different expertise. Just think of experts in the field of big data, AI, automation and robotization, energy-efficient production,…’ According to De Soete, the center in Zwijnaarde will be a game changer for the pharmaceutical industry in Flanders, which will also provide a lot of jobs.
Given the complexity and increasing diversity of products and technologies in (bio-)pharmaceuticals processing, it is clear that there will be no “one size fits all” solution for new process development and manufacturing requirements. The research in Pharmaceutical Engineering (PharmaEng) group involves development and application of a digital twin of equipment, processes, and the environment, where functions and properties are treated using various mechanistic frameworks. The research group aims to apply these digital twins to deliver solutions covering all the three aspects of pharmaceutical process development – product design, process design, and process improvement. Modeling frameworks based on first-principles such as DEM, FEM, CFD, and PBM in combination with kinetic, thermodynamic models will be used to design and optimize the system to deliver drug substances and products with desired physical properties.
Our research areas include both classical batch and continuous processing unit operations. Within these fields, we have an extensive expertise in following domains:
Process equipment design and optimization
Process and equipment scale-up
Detailed modeling of pharmaceutical processes for mechanistic insights
Advanced pharmaceutical manufacturing control strategy
Ghent University
Centre of Excellence in Sustainable Pharmaceutical Engineering
Faculty of Pharmaceutical Sciences
Campus Heymans
Ottergemsesteenweg 460
B-9000 Gent, Belgium
Christoph Portier is Project Manager, Operations at the Centre of Excellence in Sustainable Pharmaceutical Engineering and Manufacturing (CESPE). His focus is project portfolio management, supporting academic CESPE members during the project proposal phase, and facility management of the CESPE Innovation Accelerator. After obtaining his Master in Drug Development and Advanced Master in Industrial Pharmacy, he joined the Laboratory of Pharmaceutical Technology as PhD researcher. His PhD research, in collaboration with Janssen, focused on increased process and formulation understanding during continuous twin screw wet granulation and downstream processing. During his PhD, he was (co)author of 14 peer reviewed publications. Additionally, he is experienced in hot melt granulation, hot melt extrusion and development of nasal spray suspensions. He is also active as reviewer for Pharmaceutics.
An Van Den Bulcke holds a Ph.D in Chemistry (Polymer Synthesis) and has an industrial career in product development and R&D management. In 2011 she started as Business Developer at ChemTech, the Chemistry Business and Valorisation cluster at Ghent University.
As Senior Business Developer, dr. An Van Den Bulcke is responsible for the coordination and facilitation of commercialisation of new research findings to market-ready technologies and products, specifically for biomedical markets (pharma, biotech, diagnostics), personal care (cosmetics) and biomaterials markets. She is the focal point for industrial collaborations and builds a relevant network of life science companies interested in chemical expertise or novel (patented) technologies to boost their innovations. In this way, she is involved i.a.:
Managing the portfolio of collaborations with academic and industrial partners
Building and managing a strategic IP portfolio
Prospecting licensing opportunities and negotiating licensing deals
Creation of spin-off companies
Specialties: research & innovation management – technology transfer – project portfolio management – out-licensing – intellectual property – technology & business development
Ghent University
Faculty of Engineering and Architecture
Centre for Polymer and Material Technologies
Department of Materials, Textiles and Chemical Engineering
Technologiepark Zwijnaarde 130
B-9052 Gent, Belgium
Prof. Dr. Ludwig Cardon became Mechanical Engineer in 1988 and joined the University College of Ghent, Belgium since 1990. He received his Ph.D. degree in Engineering in 2006 from the Birmingham City University, UK. Since 2006, he is the head of the Centre for Polymer & Material Technologies CPMT and professor at the faculty of Applied Engineering Sciences of the University College of Ghent. He is co-founder of the rapid prototyping research group (RPT), now integrated in CPMT. His actual research interests mainly include high-tech polymer technology/processing and RPT for several applications such as technical parts, biobased polymers, micro moulding, bioengineering and biomedical applications.
Ghent University
Faculty of Pharmaceutical Sciences
Laboratory of Pharmaceutical Process Analytical Technology
Campus Heymans
Ottergemsesteenweg 460
B-9000 Gent, Belgium
Prof. dr. ir. Ashish Kumar has been working in the field of Pharmaceuticals and biologics development since 2007 in both academic and industrial set-up. Before joining Ghent University, he worked as a Senior Process Engineer at the drug product development division of Janssen Pharmaceutica, Belgium. He obtained his Ph.D. from Ghent University in 2015, for research on the experimental and model-based analysis of twin-screw wet granulation for continuous solid-dosage manufacturing in pharmaceutical production. Before, he obtained a Professional Doctorate in Engineering as a Designer in Bioprocess Engineering from the Technical University of Delft in 2011, and worked for Janssen Pharmaceutica, in Leiden, The Netherlands and Dr. Reddy’s Laboratories in India. His research interests lie in the area of developing insights regarding constitutive mechanisms of various pharmaceutical processes by combining experimental and mechanistic modeling frameworks to provide innovative solutions. The Pharma Eng research group he leads focuses on the model-based design of pharmaceutical and biopharmaceutical manufacturing equipment and processes for innovative drug products.
Valérie Vanhoorne graduated in 2011 with great distinction as a pharmacist (Master of Science in Drug Development) from Ghent University (UGent) and started her PhD under supervision of Prof. Jean-Paul Remon and Prof. Chris Vervaet in the Laboratory of Pharmaceutical Technology (UGent). In 2016, she obtained her PhD in Pharmaceutical Sciences studying continuous agglomeration technologies. She continued working in the lab as a postdoctoral researcher focusing on innovative manufacturing processes for oral solid dosage forms. Initially, she worked as a postdoctoral researcher in close collaboration with Janssen Pharmaceutica (Belgium) on the development of predictive empirical models for continuous direct compression and platform formulations for continuous twin screw granulation. Later on, as doctor-assistant, she also worked on patient-tailored dosage forms and performed a research stay at the University of Düsseldorf working on roller compaction. Her current research line will focus on formulation and process development of continuous manufacturing processes and on personalization of dosage forms (via 3D-printing and multi-particulate dosage forms) to meet the needs of specific patient populations.
Experimental planning using (AI based) Optimal Design of Experiments (DOE)
Quality & Process control
Above statistical methods are applied to: – Monitoring, assessing stability and performance of production processes – Optimization and validation of measurement systems – Modeling of industrial processes, determining “Design Space” & optimal process parameter control ranges
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