Author: Christoph Portier

We are excited to announce that professor Hristo Svilenov has joined CESPE as an academic member. With the onboarding of prof. Svilenov, we further strengthen our capabilities in the field of biopharmaceutical manufacturing.

Hristo Svilenov is a professor of biopharmaceutical manufacturing technology and formulation in the Laboratory of General Biochemistry and Physical Pharmacy at Ghent University. Before moving to Ghent, he was postdoc with Prof. Johannes Buchner at the Technical University of Munich funded by a fellowship from the Peter und Traudl Engelhorn Foundation and a grant from the Else Kröner-Fresenius Foundation. From 2016 to 2019, he did his PhD sponsored by a Maria Skłodowska-Curie fellowship in the group of Prof. Gerhard Winter at the University of Munich. For his research, Dr. Svilenov received several prizes like the Carl Wilhelm Scheele Award from the German Pharmaceutical Society (DPhG) or the Abbvie Award for the best doctoral thesis. He is a pharmacist by training.

Hristo Svilenov is working on different aspects of the development, manufacturing, and formulation of biotherapeutics. A strong research focus is on the application of novel analytical techniques and biophysical methods to design better therapeutic proteins and formulations.

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:

1. Master’s degree in pharmaceutical sciences, physical chemistry, or a related discipline
2. Experience in dissolution testing of pharmaceutical dosage forms.
3. Experience with various analytical techniques (DSC, XRD, IR, TGA, DVS, HPLC).
4. Experience in multivariate data analysis is desirable.

Mathematical modeling research focus:

1. Master’s degree in bioengineering, chemical engineering, and process engineering or a related discipline
2. Experience with the development of numerical methods
3. Experience with mechanistic and data-driven modeling methodologies
4. Experience in Python and/or MATLAB is desirable.
5. Candidates must have a strong interest in both experiments and theoretical modeling

More information
For further information, please contact:

Pharmaceutical engineering research group (Ghent University) Faculty of Pharmaceutical Sciences

Prof. dr. Ashish Kumar (Ashish.Kumar@UGent.be)

LPPAT research group (Ghent University) Faculty of Pharmaceutical Sciences

Prof. dr. Thomas De Beer (Thomas.DeBeer@UGent.be)

Laboratory of Pharmaceutical Technology (Ghent University) Faculty of Pharmaceutical Sciences

Prof. dr. Chris Vervaet (Chris.Vervaet@UGent.be), Prof. dr. Valérie Vanhoorne (Valerie.Vanhoorne@UGent.be)

How to apply

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

1. Master’s degree in Pharmaceutical Drug Development, Industrial Pharmacy, Pharmaceutical Engineering, Bio-science Engineering, Chemical Engineering or a related discipline.
2. Experience with pharmaceutical technology is desirable.
3. Candidates must have a strong interest in biopharmaceutical product development manufacturing innovation, analysis and data-analysis.

The PhD project will be guided by the Pharmaceutical Process Analytics & Technology research group (Faculty of Pharmaceutical Sciences, Ghent University, Prof. Dr. Thomas De Beer), and will be in collaboration with the Pharmaceutical Engineering Research Group (Prof. Dr. Ashish Kumar).

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

Application deadline

Please apply before February 28th, 2022

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.

More information

Thomas De Beer, thomas.debeer@ugent.be

Wouter De Soete, wouter.desoete@ugent.be