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2 PhD Positions to develop a Predictive Framework enabling Real-Time Release Testing in Solid Dosage Manufacturing

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.

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2 Vacant PhD Positions on Continuous Pharmaceutical Freeze-Drying

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

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Ghent University takes the lead in the production of tomorrow’s medicines

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.

cleanroom
Researcher in a cleanroom, © Ghent University, photo Hilde Christiaens

‘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.

cleanroom
Researchers in a cleanroom, © Ghent University, photo Hilde Christiaens

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

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Takeda Lessines and Ghent University’s Innovation Cluster CESPE Enter into Pharmaceutical Manufacturing Innovation Partnership

Ghent (March 25, 2021) – Takeda and Ghent University (UGent) are pleased to announce that Takeda’s Global Manufacturing Site at Lessines has officially joined the CESPE innovation cluster, a multi-partner innovation accelerator in the field of pharmaceutical engineering and manufacturing. This strategic partnership reflects both parties’ strong desire to further intensify their research and innovation efforts and to make optimal use of the cross pollination between industry and academia. Initially, this partnership will focus on optimising digitization in Pharma 4.0, pharmaceutical technology innovation, and optimising energy and material efficiency during production.

“As one of the global leaders in the production of plasma derivatives, Takeda continuously improves its manufacturing operations. To this end, the mutual sharing of knowledge with other companies and knowledge institutions like CESPE is key”

— Gert Verheyden, Head of Manufacturing Sciences at Takeda Lessines —

“As one of the global leaders in the production of plasma derivatives, Takeda continuously improves its manufacturing operations. To this end, the mutual sharing of knowledge with other companies and knowledge institutions like CESPE is key”, says Gert Verheyden, Head of Manufacturing Sciences at Takeda Lessines. “This allows Takeda Lessines to make a significant contribution to the training of tomorrow’s pharmaceutical engineers, both in existing and emerging education tracks, and also to increase the industrial relevance of possible innovation projects at the international level.” “We are thrilled to collaborate with Takeda and to thus facilitate its strong desire to implementing innovative production processes of active pharmaceutical ingredients and finished pharmaceutical products. We are collaborating precompetitively with an industrial network to build a strong knowledge region enabling the local anchoring of talent and innovation”, says professor Thomas De Beer, Director of CESPE.

Copyright Takeda

 About Takeda

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline.

Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

For more information, visit https://www.takeda.com.

About UGent-CESPE

Ghent University (UGent) is a top 100 university and one of the largest Belgian universities in the heart of Europe. It is an active partner in national and international educational, scientific and industrial cooperation. The organization is committed to research and innovation with an annual research budget of more than € 600 million and more than 5,500 researchers active in a wide range of the life, physical and social sciences. UGent TechTransfer and the UGent Business Development Platforms, such as CESPE, support researchers in developing groundbreaking science to bring innovations to the market.

The Centre of Excellence in Sustainable Pharmaceutical Engineering and Manufacturing (CESPE) is a multidisciplinary innovation accelerator hosted at Ghent University focusing on the sustainable development, design and optimization of both drug substance and drug product production platforms. Its ambition is to become the reference centre in end-to-end (bio)pharmaceutical manufacturing in Europe. It accelerates the development of emerging production technologies to manufacture the medicines of the future in a sustainable, agile way.

For more information, visit https://www.cespe.be.

Media Contact:

Takeda:
Stefaan Fiers, Head of Corporate Communication
Tel: 0476 76 90 77

CESPE:
Wouter De Soete, Manager
Tel: 0474 80 65 67

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Partner simAbs is hiring

Great job opportunity! Want to develop your Process Development Engineering skills? Our partner simAbs, developing a new biopharmaceutical manufacturing platform, might have just the challenge you’re looking for! Check out the job offer here!

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News Partnership day 2020

CESPE Industrial Partnering Day 2020

SUSTAINABLE PHARMACEUTICAL MANUFACTURING INNOVATION
– RECORDINGS –

Did you miss any of the presentations during the CESPE Industrial Partnering Day 2020?
Review them here! Full stream available!

Welcome

Rik Van de Walle, Ghent University, Rector
Sofie Bracke, City of Ghent, Alderman for Economy, Trade, Sport & Port

Introduction to CESPE

Introduction to CESPE (Wouter De Soete, CESPE Manager)

Keynote “Belgian Biotech: Evolution & Revolution”

Geoffrey Pot, Chairman of the Board Bio.be/essenscia, Takeda Site Head, VP Operations

Industry Testimonial: Janssen Pharmaceutica

Jan Van der Goten, Head of Strategic Campus Office, Janssen Pharmaceutica

Research and Innovation pitches

Prof. Chris Stevens, Microreactor Technology: One Flow, One Product
Prof. Thomas De Beer, Prof. Ingmar Nopens, The Future of Pharmaceutical Drug Product Manufacturing
Prof. Richard Hoogenboom, Poly(2-oxazoline)s as Novel Excipients for Oral Formulations
Prof. Ludwig Cardon, 3D Printing: An Innovative Manufacturing Method
Prof. Kevin Van Geem, Maarten Dobbelaere, Artificial Intelligence for Computer-Aided Synthesis in Flow
Prof. Joris Thybaut, Chemical Reactor Performance Assessment and Innovation by Modeling
Prof. Jo Dewulf, Sustainability Assessment in Pharmaceutical Manufacturing
Prof. Dieter Claeys, Jeroen De Maeyer, Industry 4.0 Operational Excellence for Pharma 4.0

Company pitches

Koen Dierckx, simAbs, CEO, Integrated Continuous Bioprocessing of Monoclonal Antibodies
Pieter-Jan Van Bockstal, RheaVita, Project Manager Technology, A Continuous Freeze-Drying Technology for Fast, Flexible and High Quality Manufacturing of Biopharmaceutical Products
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CESPE industrial partnering day

SUSTAINABLE PHARMACEUTICAL MANUFACTURING INNOVATION

SAVE THE DATE for the first CESPE Industrial Partnering Day!
December 2nd, 2.00pm – 5.00pm
Feel free to forward within your organisation 

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.

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PHD position open in pharmaceutical technology!

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.

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HANDS-ON WORKSHOP ON BATCH VERSUS CONTINUOUS PHARMACEUTICAL FREEZE-DRYING, OCTOBER 16-18, GHENT

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
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CESPE PRESENTS AT KNOWLEDGE FOR GROWTH 2018

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/