Author: Bram Bekaert

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CESPE Academy Courses

Material characterization

COURSE OVERVIEW

This course gives an introduction on the (pharmaceutical) relevance of (raw) material characterization. An overview is given about the relevant characterization methods on the market, their applicability and how the material properties can be used to describe the processability.
This 1-day course consists out of a theoretical (interactive) and hands-on part.

MODULE 1: BASIC COURSE

Theoretical

The trainee will get an in-depth explanation about the different characterization methods, their (pharmaceutical) relevance and what you can do with the generated data.
Some of the key material characteristics described are:

Flow/cohesion
&
Particle size and shape
&
Density and porosity
&
Electrostatic charge
&
Melting point and crystal structure
&
Viscosity

Practical

Hands-on sessions will allow the trainee to get a feel with what it takes to characterize a material.
The extensive array of characterization equipments, available at CESPE, will be made available to visualize the difference between highly divergent powders.
Some of the equipment that will be used are:

FT4 Powder Rheometer
&
Schulze Ring Shear Tester
&
GranutoolsTM equipment
&
Malvern Laser diffractors
&
DVS and DSC equipment

Upon request, a powder of interest could be tested on the available equipment!
For more information, please contact Bram.Bekaert@UGent.be .

COURSE PROGRAM

A detailed overview of the course can be found in the following document.

Material-characterization-1Download

If you are interested in following this course, please take a look at planned sessions.
For further questions or requests, please use the contact form.

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CESPE Academy Courses

Process Analytical Technologies

COURSE OVERVIEW

This course focusses on giving a thorough introduction about the implementation of PAT tools in the (bio)pharmaceutical industry.
This course is given in an interactive manner (both theoretical and hands-on) and can be divided into three separate modules:

Module 1: Basic course: Introduction to PAT implementation (1-day module)
&
Module 2: Advanced course: Data-analysis and modelling (Python) (2-day module)
&
Module 3: Specialized courses (1/2-day module)

Requirements
Basic understanding of spectroscopy and (bio)pharmaceutical processes
&
Basic understanding of coding and programming (python)

MODULE 1: BASIC COURSE

Theoretical

The trainee will get an in-depth explanation about the common (non-)spectroscopic PAT sensors and will learn how, when and where these tools can provide a benefit.

Spectroscopic PAT tools
&
Non-spectroscopic PAT tools
&
Hyperspectral imaging
&
PAT in R&D
&
Regulatory aspects
&
Multivariate data-analysis

Practical

The trainee will get the chance to see how PAT tools can be implemented and how this translates in a practical approach to acquire relevant process information.
Some of the tools that will be demonstrated are:

NIR
&
Raman
&
Other PAT devices

MODULE 2: ADVANCED COURSE

Theoretical

This module looks at the steps that follow after a successful implementation of the PAT tools. The trainee will learn on how to analyze and use the acquired data in multivariate models.

Introduction to Python
&
Data preparation
&
Linear and non-linear modelling
&
Multivariate data-analysis

Practical

During the course, the trainee will use placebo data sets to learn how to analyze and use the data.

MODULE 3: SPECIALIZED COURSES

In this module, the goal is to highlight specific examples, using real spectroscopic data in the form of use-cases.

Topics

Model predictive control
&
Unit operation-specific spectroscopic data-analysis
&
Bring your data to course day*

*The trainee has the option to bring his/her own data to the course. Together with the tutor they can go through the data and learn how to proceed.

COURSE PROGRAM

A detailed overview of the different modules can be found in the following document.

Process-Analytical-TechnologiesDownload

If you are interested in following this course, please take a look at planned sessions.
For further questions or requests, please use the contact form.

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CESPE Academy Courses

Tableting 101

COURSE OVERVIEW

Tableting 101 focusses on giving a thorough introduction about the tableting process in an interactive manner (both theoretical and hands-on).
This course is divided into two separate modules:

Module 1: Basic course: Introduction to tableting (1-day module)
&
Module 2: Specialized courses (1-day module)

MODULE 1: BASIC COURSE

Theoretical

The trainee will get an in-depth explanation about the basic tableting aspects such as:

Tableting equipment
&
Tablet formulation
&
Tablet quality
&
Tableting process
&
Compaction mechanisms and models

Practical

Hands-on sessions will allow the trainee to get a feel with the tableting process and how this process can influenced by divergent factors.
The hands-on session will be performed on:

Compaction simulator
&
Rotary tablet press (MODULTM P)

MODULE 2: SPECIALIZED COURSES

In this module, the goal is to highlight specific aspects of the tableting process through different use-cases. Each use-case allows the trainee to get an in-depth comprehension of a specific part of the tableting process.

Topics

Lubrication (internal/external)
&
Sticking
&
Die filling
&
Compaction models
&
Upscaling of the tableting process

The trainee has the option to take up all of the provided topics, covering a full day course, or select a sub-set of these topics.

COURSE PROGRAM

A detailed overview of the different modules can be found in the following document.

Tableting-101Download

If you are interested in following this course, please take a look at planned sessions.
For further questions or requests, please use the contact form.

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CESPE Academy Courses

Lyophilization 101

COURSE OVERVIEW

Lyophilization 101 focusses on giving a thorough introduction about pharmaceutical freeze-drying in an interactive manner (both theoretical and hands-on).
Throughout this 2-day course, the trainee gets to understand the basic and fundamental aspects from start untill finished product.

MODULE 1: BASIC COURSE

Theoretical – day 1

During the first day of the course, the trainee will get an in-depth explanation about the basic freeze-drying principles such as:

Freeze-drying equipment
&
Heat and mass transfer mechanisms
&
(Dis)advantages
&
Modelling of the freeze-drying cycle
&
Optimization of the process

Practical – day 1

Hands-on sessions will allow the trainee to get a feel with the freeze-drying process.
The hands-on session will cover:

Tour of the CESPE freeze-drying lab
&
Sample preparation and characterization
&
Starting your first run

Theoretical – day 2

During the second day, the focus will be put on PAT implementation and post-run analytics, allowing the trainee to deep-dive in the generated data.

Process analytical technologies (PAT)
&
Pre- and Post-run analytics
&
The future of freeze-drying: Continuous vs. Batch

Practical – day 2

Hands-on sessions during day 2 will mainly focus on the analysis of the performed run of practical day 1.
The hands-on session will cover:

Evaluation of the freeze-drying run
&
Water content determination
&
DSC
&
Sneak-peek at a continuous freeze-dryer

COURSE PROGRAM

A detailed overview of the program can be found in the following document.

Lyophilization-101Download

If you are interested in following this course, please take a look at planned sessions.
For further questions or requests, please use the contact form.

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CESPE Academy Courses

Twin screw granulation 101

COURSE OVERVIEW

Twin screw granulation 101 focusses on giving a thorough introduction about the granulation process in an interactive manner (both theoretical and hands-on).
This course can be divided into three separate modules:

Module 1: Basic course: Introduction to twin screw wet granulation (1-day module)
&
Module 2: Basic course: Introduction to twin screw hot-melt granulation (1/2-day module)
&
Module 3: Specialized courses (1/2-day module)

MODULE 1: WET GRANULATION

Theoretical

The trainee will get an in-depth explanation about the basic twin screw wet granulation aspects such as:

Equipment overview
&
Principles of wet granulation
&
Batch vs continuous manufacturing
&
Process and formulation parameters
&
Granule characterization

Practical

The in-house ConsiGmaTM -25 line will be used to demonstrate the twin screw wet granulation process. Afterwards, the produced granules will be tested using the available granule characterization methods.
The hands-on session consists out of:

ConsiGmaTM-25 demonstration with placebo
&
Introduction to granule characterization methods

MODULE 2: HOT-MELT GRANULATION

Theoretical

The trainee will get an in-depth explanation about the basic twin screw hot-melt granulation aspects such as:

Equipment overview
&
Fundamentals of hot-melt granulation
&
Equipment configurations and settings
&
Pitfalls
&
Granule characterization*

*Will be skipped if module 1 was followed as well.

Practical

The trainee will be able to follow and help during placebo trials using a twin screw hot-melt granulator. The influence of process and formulation parameters will be demonstrated.

MODULE 3: SPECIALIZED COURSES

In this module, the goal is to highlight specific aspects of the granulation process through different use-cases. Each use-case allows the trainee to get an in-depth comprehension of a specific part of the process.

Topics

Wet granulation: Modified release formulations
&
Wet granulation: Impact of dry or wet addition

The trainee has the option to take up all of the provided topics, covering a half day course, or select a sub-set of these topics.

COURSE PROGRAM

A detailed overview of the different modules can be found in the following document.

Twin-screw-granulation-101Download

If you are interested in following this course, please take a look at the planned sessions.
For further questions or requests, please use the contact form.

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CESPE Academy Courses

Feeding 101

COURSE OVERVIEW

Feeding 101 focusses on giving a thorough introduction about the feeding process in an interactive manner (both theoretical and hands-on).
This course is divided into two separate modules:

Module 1: Basic course: Introduction to feeding (1-day module)
&
Module 2: Specialized courses (1/2-day module)

MODULE 1: BASIC COURSE

Theoretical

The trainee will get an in-depth explanation about the basic feeding aspects such as:

Types of feeding equipment
&
Feeder accessories and their function
&
Types of feeder trials
&
Feeder data acquisition and analysis

Practical

During the hands-on sessions, the trainee will learn on how to install, operate and dismantel a loss-in-weight feeder.
The feeder demonstrations will be performed using two divergent materials.

Upon request, a powder of interest could be tested on the available equipment!
For more information, please contact Bram.Bekaert@UGent.be .

MODULE 2: SPECIALIZED COURSES

In this module, the goal is to highlight specific aspects of the feeding process through different use-cases. Each use-case allows the trainee to get an in-depth comprehension of a specific part of the process.

Topics

Surrogate approach for feeding
&
Impact of glidant addition
&
How specific configurations and settings can impact the feeding performance

The trainee has the option to take up all of the provided topics, covering a full day course, or select a sub-set of these topics.

COURSE PROGRAM

A detailed overview of the different modules can be found in the following document.

Feeding-101Download

If you are interested in following this course, please take a look at planned sessions.
For further questions or requests, please use the contact form.

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News

PhD vacancy

One of the CESPE research groups (The Laboratory of Pharmaceutical Technology) is recruiting a full-time Ph.D. student in the field of continuous manufacturing of pharmaceuticals.

You will have the chance to play an important role within the domain of pharmaceutical technology, more specifically in the field of (continuous) manufacturing of pharmaceutical dosage forms.
During your Ph.D. you will get the chance to publish your research data in international peer-reviewed papers; assist in the teaching activities at the Laboratory of Pharmaceutical Technology, including the guidance of master dissertations; and assist in the internal and external services by the Laboratory of Pharmaceutical Technology.

Don’t hesitate to take a look at the vacancy.

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News

Master of Science in Pharmaceutical Engineering (MPE) is accepting applications!

Ghent University is now accepting applications for our Master of Science in Pharmaceutical Engineering (MPE) program. Our program offers a unique combined training of pharmaceutical and engineering skills. Both skills are required to develop these pharmaceutical production processes for tomorrow’s drug products and supply needs.
The MPE consists of a two-year English-taught programme of 120 credits and will help you acquire all skills and knowledge that you need to implement novel manufacturing concepts that require a high degree of digitalization and automation. The MPE will also increase your opportunities to get a good position in the pharmaceutical industry or to become an excellent PhD candidate!

For further information, please take a look at the MPE site: https://lnkd.in/gXFbn42H.

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Industrial members

Janssen Pharmaceutica

Field of Expertise:
R&D, manufacturing and new product launch

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Field of Expertise:
R&D, manufacturing and new product launch

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The Janssen campus in Belgium (or Janssen Pharmaceutica) is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. A unique fusion of expertise, capabilities and partnerships in R&D, manufacturing and new product launch. Together, they are creating a future where disease is a thing of the past.

As an innovative campus, they focus on important fields of research such as neuroscience, oncology, immunology, infectious diseases, cardiovascular and metabolism and pulmonary hypertension. Fields in which the unmet medical need is high and much is to be done and to achieved.

Janssen in Belgium has been focusing on research and development for more than 60 years. The campus in Belgium has been instrumental in the discovery and development of a new generation of tuberculosis, HIV/AIDS, cancer, infectious diseases and neurological drugs. It was here in Beerse that the first FDA-approved tuberculosis drug in 40 years was discovered and developed.

From early research and development, through supply chain to patient access – their people are making an important contribution to the health of many.

OTHER INDUSTRIAL MEMBERS

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Industrial members

Takeda

Field of Expertise:
Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI)

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Field of Expertise:
Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI)

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Industrial members

Pfizer

Field of Expertise:
Vaccines and sterile injectables

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Field of Expertise:
Vaccines and sterile injectables

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Industrial members

Cognizant

Field of Expertise:
IT services and IT consulting

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Field of Expertise:
IT services and IT consulting

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Cognizant engineers modern businesses. They help their clients modernize technology, reimagine processes and transform experiences so they can stay ahead in the fast-changing world.

Cognizant uses expertise that’s been proven and tested around the globe to help their customers get ahead of challenges, sense opportunities sooner and outpace change.

They develop game-changing digital solutions in many different fields of expertise:

  • Digital Engineering
  • Intelligent Process Automation
  • Industry & Platform Solutions
  • Internet of Things
  • Artificial Intelligence
  • Cloud
  • Data
  • Life Sciences
  • Healthcare
  • Manufacturing
  • Technology
  • …

OTHER INDUSTRIAL MEMBERS

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Conference 2023 News

CESPE Conference 2023

Challenges & Solutions for transitioning to sustainable (bio)pharmaceutical manufacturing

CESPE is pleased to announce the second edition of the annual CESPE Conference on Thursday September 21, 2023.

Through insights from different stakeholders, this event aims to address and tackle the current challenges related to the transition into a more sustainable (bio)pharmaceutical industry.

  • Where are the current bottlenecks limiting innovation and how can we solve them?
  • Which tools are required to achieve these ambitious goals?
  • What is the role of both academia and industry?

The physical event in Ghent will provide you with many opportunities to network with our academic members, industrial partners and policy makers. Therefore, it 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!

For further information on booths and sponsorships, feel free to contact Christoph Portier (Christoph.Portier@UGent.be) or Bram Bekaert (Bram.Bekaert@UGent.be).

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Industrial members

AM-Team

Field of Expertise:
Advanced modelling services for process optimisation and design

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Field of Expertise:
Advanced modelling services for process optimisation and design

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AM-Team was founded in 2017 by Dr. Wim Audenaert, Dr. Usman Rehman, and Prof. Ingmar Nopens, all having MSc and PhD degrees in either chemical or environmental engineering. AM-Team is a spinoff company of Ghent University with over a decade of expertise in process modelling and simulations.

Customers from all over the globe rely on their leading-edge simulation services and digital tools. They keep on developing tailored digital solutions to match the needs of their customers in the process industry.

They do this by: 

  • Developing new process models and methodologies to maximise customer experience and cater the industry needs
  • Sharing their expertise at high-level international events and publishing new findings in peer-reviewed scientific papers, often together with customers
  • Investing in new hardware and software to maximise simulation speed and accuracy

Thanks to their large team of dedicated simulation engineers, they can handle large projects in a short timeframe. 

OTHER INDUSTRIAL MEMBERS

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Industrial members

Secoya Technologies

Field of Expertise:
Crystallization, emulsification, pervaporation, process intensification

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Field of Expertise:
Crystallization, emulsification/encapsulation, pervaporation, process intensification

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Secoya Technologies is a global provider of services and equipment in particle engineering for the (bio)-pharmaceutical industry. Secoya’s experts have been developing innovative production technologies and equipment by a smart use of micro-structured elements, enabling a faster, precise and secure development and production process.

Their ranges of robust intensified reactors guarantee a stable and reliable production process – at different scale – of high quality (bio-)pharmaceutical products. Their core principle is applied to following technologies and in-house expertise service:

  • Crystallization (small molecules, API, excipients…)
  • Emulsification / Encapsulation (simple and double emulsion for encapsulation of biomolecules, API…)
  • Pervaporation
  • Process intensification

The integration of their unique, robust and versatile technologies in their equipment, combined with their unique know-how, allows them to guide their partners with mastering every aspect of the manufacturing process, from laboratory scale to commercial production scale the size of the particles generated and their size distribution as well as to increase the efficiency, productivity and flexibility. Whether it is the development of new products or the improvement of existing products, Secoya’s technologies provide many key benefits:

  • Unmatched product quality and secure production
  • Implementation of Quality-by-Design
  • Reduction of investment cost and risk for the process development
  • Reduction of cost of goods sold
  • Inherent compatibility with continuous manufacturing
  • Manufacturing of new possible molecules

OTHER INDUSTRIAL MEMBERS

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News

Job Opportunity: Project Manager CESPE

The CESPE team is expanding!!

Apply for an exciting and challenging job position and help the team in pioneering next-generation pharmaceutical manufacturing.

Get more information and apply here before March 31: https://lnkd.in/ePDnMk3t

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Industrial members

RheaVita

Field of Expertise:
Continuous & controlled freeze drying

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Field of Expertise:
Continuous & controlled freeze drying

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RheaVita sells single vial (for R&D), non-GMP multi-vial (for scale-up and stability studies), and full GMP continuous freeze-drying systems.

Next to our engineered solutions we also offer freeze-drying related CDMO services. The freeze-drying of biopharmaceuticals, LNP-based formulations, ATMPs, and other small and large molecules, requires proper formulation and process optimization of the drug substance. Designing the optimal formulation based on the drug substance properties and characteristics is crucial. Furthermore, by applying a model-based strategy, RheaVita provides the opportunity to efficiently design and optimize your freeze-drying process in an extremely fast way with limited product consumption. 

Our manufacturing approach avoids scale-up issues, reduces cycle times, allows fast product development, reduces time-to-patient, lowers production costs, makes use of smaller manufacturing installations, requires less clean room space, provides improved quality assurance thanks to PAT (100% inspection with inherent potential for real-time-release) and leads to improved and uniform product quality and process uniformity.

RheaVita has also set up an academy to share knowledge on freeze-drying where our customers receive a fundamental insight into freeze-drying and analysis of the results and experience the benefits of continuous manufacturing technology.

OTHER INDUSTRIAL MEMBERS

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News

Professor Dieter Deforce and CESPE join hands

It is with great honour that we can announce professor Dieter Deforce as a new academic member of CESPE. His expertise in the fields of pharmaceutical biotechnology and (forensic) DNA-analysis are a crucial addition to the CESPE portfolio.

Dieter Deforce is a professor at the University of Ghent and is the head of the Laboratory of Pharmaceutical Biotechnology at the Faculty of Pharmaceutical Sciences. From 2001 till 2016 he was also head of the forensic DNA‐analysis laboratory, which he founded at the University of Ghent, accredited and recognized by the Belgian government. He remains in the forensic field as dedicated DNA expert.

He is chair of the Belgian Medicines Committee, member of the Scientific Advise Working Party of the European Medicines Agency. He is also the director of the ProGenTomics platform of the University of Ghent, providing amongst others proteomics and mainly mass spectrometry based protein analytical tools to the research community. He is a partner in NXT‐GNT, a research consortium providing the research community next generation DNA‐sequencing. He is member of the board of directors of the VIB.

His research focuses on applying proteomics and genomics platforms (including Next Generation Sequencing) in the field of post translational protein modifications, stem cell development, prenatal genetic diagnosis, (auto‐)immunity and forensics and he is (co‐)author of over 350 scientific papers.

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Research groups

DySC

Field of Expertise:
Modelling, process control, identification, multi-objective process optimization, multivariable control

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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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Research groups

Epidemiology of Chronic Diseases

Field of Expertise:
Burden of disease, patient-reported health outcomes, health economic techniques

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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.

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Team

Dr. Bram Bekaert

Cespe Project Manager, Operations

Ghent University
Centre of Excellence in Sustainable Pharmaceutical Engineering & Manufacturing
Faculty of Pharmaceutical Sciences
Campus Heymans
Ottergemsesteenweg 460
B-9000 Gent, Belgium

bram.bekaert@ugent.be

+32 9 264 81 18

Bram Bekaert is Operational Manager at the Centre of Excellence in Sustainable Pharmaceutical Engineering and Manufacturing (CESPE). He will focus on technical support for the CESPE Innovation Accelerator & Incubator, attracting additional funding for the further development of the CESPE Innovation Accelerator & Incubator, and coordinating grant reporting to the Department of Economy Science and Innovation (EWI). Additionally, he will have a supporting role in attracting industrial partners for commercialisation of the CESPE Incubator and maintaining relationships with internal and external policymakers.

After obtaining his Master in Drug Development, Bram Bekaert continued his pharmaceutical career as a PhD researcher at the Laboratory of Pharmaceutical Technology. His PhD research, in collaboration with Janssen Pharmaceutica (Belgium) and Fette Compacting Belgium, focused on improving process knowledge about continuous direct compression with a core focus on the feeding and blending unit. Additionally, he gained experience in material characterization, PAT implementation and hot melt granulation. Bram Bekaert obtained his PhD in 2021 and decided to remain at the faculty as a postdoctoral researcher where he continued his focus on continuous direct compression as part of the Laboratory of Pharmaceutical Engineering.

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Team

Dr. Bart Hommez

Business Developer

Ghent University
Industrial Research Fund
Tech Lane Ghent Science Park - Campus Ardoyen
Technologiepark 125
B-9052 Zwijnaarde-Gent, Belgium

Bart.Hommez@UGent.be

+32 9 264 96 03

Bart Hommez obtained his PhD in Chemistry (polymer chemistry) from Ghent University. After his PhD he worked for 10 years within the lubricants industry (automotive and industrial applications), followed by 3 years in innovation consulting for SME’s. Today Bart is active as business developer for Ghent University where he leads the exploitation of research output in close collaboration with the research teams within the field of chemical engineering and modelling.