In this blog post, we give more insights into the challenges a QP faces when dealing with ATMPs. We talk about sterility, out-of-specification handling, batch release, and EU import testing.
The sales price of cell and gene therapies is influenced by multiple factors like Cost of Goods (COG), regulatory requirements, target market (or commercial aspect), and the development just to name a few. In this blog post you will learn more about the GOC aspect: what is this cost comprised of and how can you reduce it?
UDI is a new system that assigns a unique barcode to each individual medical device. It will become mandatory when MDR and IVDR enter into force, so as a manufacturer, you need to make sure you’re UDI-ready in time.
During the QbD Corona World Games, our online international team building event, thirteen randomly selected teams defended their honor.
A short introduction and overview of the requirements In 2017, the European Commission released the new Medical Device Regulation (MDR) that will replace the Medical Device Directive (MDD) in May 2021. The regulation has been written to assure better quality and improve the safety aspects for all medical devices that
One of our previous blogposts discussed innovations in the medical technology field and how these can fulfill unmet patients’ and physicians’ needs by leveraging the latest technological advancements. It is undeniable that the future of medical technology looks exciting and, obviously, being innovative requires a lot of specific technological expertise
Do you want to distinguish starting materials used for ATMPs from those used for transplants or transfusions? This distinction is made based on how the starting materials are processed and/or used clinically. We’ve listed the steps to make such a distinction, with the help of a flowchart. Current ATMP workflows
Recently, we announced that Quality by Design and TRIUM Clinical Consulting have joined forces to create an end-to-end offering for the lifecycle of medical products and therapies. A giant leap forward in the growth, expansion and development of both companies. Are you curious as to why TRIUM is the ideal
Among the Advanced Therapy Medicinal Products (ATMPs), in the immunotherapy market, nowadays two acronyms catch the eye: CAR-T and TCR-T. The two techniques are based on the insertion of a specific receptor on the T-cells to enable them to detect and kill the tumor cells specifically. When the receptor is
It’s obvious that product quality and patient safety are a top priority in the pharmaceutical industry. The quality by design methodology is used to build quality into production processes. By a comprehensive understanding of and insight in products and processes, continuous improvement of products and processes is possible. But how
GxP Processes Without question, the impact of GxP processes such as product quality and patient health are at the top of the list when it comes to assessing the risks of a computer system. These are crucial in deciding whether to validate a computerized system. Therefore, experience and end user
What does an automation pyramid entail? An automation pyramid visualises the integrated layers of technology used in manufacturing or industry combined with the level of control. From the bottom, where the production runs on motors, machinery, actuators, sensors and so on, to the top where the process is managed. How
In the first blog we discussed the definitions of validation and computerized systems. Checking the fitness of the system is to check whether the system operates according to the needs of the process for which it is acquired.
Have you read our earlier blogposts about the The importance of a dedicated team and skilled project manager for technology transfers, the factors that can make or break your technology transfer, and the drivers of complexity in tech transfers?
Until now, academia and research-based companies have been the major source of successful ATMP (gene therapy and cell- or tissue-engineered product) developments. Based on their success, pharmaceutical companies are trying
In the first blog we discussed the definitions of validation and computerized systems. Checking the fitness of the system is to check whether the system operates according to the needs of the process for which it is acquired.
Checking your phone to see when you took your last medication? Your watch vibrating and telling you to lay down because you will have a seizure soon, while at the same time notifying your emergency contact with your exact location?
Have you read our earlier blogposts about the factors that can make or break your technology transfer, and the drivers of complexity in tech transfers?
Life sciences enterprises in for example the pharmaceutical, biotechnology and medical devices industry must validate computer systems that have an impact on the product and thus the patient safety. A computer system consists of more than just software and hardware; it includes procedures, processes, equipment, training and much more. In
On the 4th of May, it was the turn of Maaike Tuinsma (Pharmaceutical Consultant at QbD) to give the Biomedical Engineering students of the University of Liège a lecture. Topic of this week: FDA & Medical Devices.
In this blogpost, we will dive into these complexities a little bit more and provide you with some useful tips to minimise the complexity of your tech transfers.
Monday 27 April, the fourth QbD guest lecture was on the agenda for the Biomedical Engineering students of the University of Liège. This time the students were introduced to software as a medical device and validation & qualification by QbD’ers Bart Verlinden and Pieter Smits.
(This blog is part of a series. Want to read the first part? Check it out here) After the Easter holidays, QbD resumed its guest lectures for the biomedical engineering students at the University of Liège. This week, our experienced consultants Jeroen Verhoeven and Steven Vinckx introduced them to the
A technology transfer can take place between buildings on the same production site, between different production plants from the same company or even between different companies. It can involve the transfer of various aspects, such as information, expertise, processes and assets. Thorough understanding between the sending and receiving units is
This blogpost aims to provide useful information for parties involved in the development of face masks in the fight against the COVID-19 pandemic. It lists the impact of the recommendations from the European Commission [1] on the development and distribution of face masks. In general, two types of face masks
Innovation is key to the success of companies and is driving many industries. This is certainly true for the medical technology sector. According to yearly research by the European Patent Organization (EPO) on filings and applications per field of technology, 13.833 med tech patent applications were filed in 2019. Contrary
A hiring freeze during Corona? No way! Although the current crisis has created new and unexpected challenges, QbD is not the kind of company to let these get in the way. In order to keep getting things done for our clients, our HR department is going the extra mile to
As long as the COVID-19 measures are in place, the QbD recruitment team continues to work from home. But thanks to modern technology, and our ‘getting things done’ mentality, it’s business as usual at QbD! Wondering what a working day looks like for our recruiters Tim and Karen? 9.00 am:
Hi! My name is Frederick Tison. I’m 26 years old and this is my third year at QbD. I’m currently active as a raw material specialist for a client. Together with fellow QbD’er Tijs Van Den Berghe, I’m responsible for setting up specifications for the raw materials that are purchased
What is the definition of ATMP? From the website of EMA: Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer ground-breaking new opportunities for the treatment of disease and injury. ATMPs can be classified into three main types: Gene
The next episode in the guest lecture program for the students Biomedical Engineering at the University of Liège was a new experience for both trainers and trainees. Some social distance had to be covered by means of a webinar and some high-end glass fiber internet cabling. From our Kot in
As you know, QbD is a very sporty and healthy organization. Since today is the start of homework and social distancing week 2, we obviously miss our weekly Bootcamp together. But thank god for technology! We were able to set up a Bootcamp via livestream in collaboration with our beloved
There we were, in the ‘quartier Polytech’, looking for the department ‘Aérospatiale & Mécanique’ at the university of Liège. We had gotten up way too early in the morning, but a small holiday feeling at 8 AM on Monday was our reward, as we crossed the language border – Liège
Advanced therapy medicinal products (ATMP) is the group of therapies in which we use cells, genes, engineered tissues and combinations of the above with medical devices as a medicinal product. A medicinal product can be described as: any substance or combination of substances presented as having properties for treating or
Advanced therapy medicinal products (ATMP) are cell and gene therapies that provide new opportunities for the treatment of a variety of diseases and injuries. Due to the specificity and novelty of the ATMP sector, the development of these therapies faces a unique set of challenges. Artificial intelligence (AI), a broad
The past of Computer Systems Validation has served us well and provided us with the foundation of where we are today. But at some point, the past can become a burden. This is exactly the point in time where we have arrived.
As Production Support Engineer I support my client Biocartis with issues associated with the production process. Depending on the problem, it is my job to either involve other departments or to solve it within the department. I also train operators and supervisors and prepare Biocartis for the future, by tackling
The clock is ticking for Brexit. By 31 October 2019, a final agreement on the matter must be reached. There is no doubt that the UK leaving the European Union (EU) will have an enormous impact on the UK and EU member states.
When it comes to the market release of vaccines, there are some specific requirements and legislations that companies need to keep in mind. In this blog post, we will pay attention to the market release of vaccines onto two of the most important markets worldwide: the European Union and the United States of America. Although they are quite similar, there are some interesting differences when it comes to testing, documentation and certification.
It’s time again for a closer look into the daily life of another one of our QbD’ers! Meet Julie Bondroit, one of the members of our amazing HR team at the head office in Wilrijk. Does this sound interesting to you? Don’t hesitate to send us your resume. Hi all!
QbD is known for its team spirit and sporty character. This isn’t only the case at the office, but also outside of work!
s week, it’s pharmacist Evelyne Goudezeune’s turn to bring us along for a typical ‘Day in the QbD Life’, filled with several meetings and a very entertaining evening. Like what you read? Then make sure to send us your cv to join our amazing team
The manufacturing and sale of medicine is big business. As a result, falsified medicines are a serious threat to patients that are dependent of safe and reliable medication. Therefore, many countries have rules and regulations in place to prevent such medicine from entering the supply chain. The approach of the
Time to invade another QbDer’s privacy! In her ‘Day in the QbD life of…’, Lieve De Wolf gives us a closer look into a typical day as QbD employee, filled with challenging work and a healthy dose of joy. Like what you read? Then make sure to send us your
Backed by increasing investments from commercial sponsors, the development of advanced therapy medicinal products (ATMP) is growing strongly in the United Kingdom. For good reason, the country is described as a growing hub for the development and manufacturing of cell and gene therapies. Less well-known is the fact that Belgium
Imagine explaining the use of Excel and all its functions to someone who has never worked with the program before – in a written manual. Where would you start? By explaining how to open the spread sheet program perhaps, followed by the question how to create new documents, formulas or
The qualification and validation group within QbD organized their first Competence Center a few weeks ago. This forum is used to discuss interesting topics concerning qualification and validation in general. As our main topic for 2019, we selected process validation to be the focal point. In three sessions, spread over 2019, the
Los países confían en el uso de productos sanitarios para lograr una cobertura de salud universal, responder a emergencias de salud y mantenerla seguridad de la población. Vemos empresas que diseñan y desarrollan cada vez más y más dispositivos e intentan encontrar su camino hacia la aprobación de comercialización. Entre
Countries rely on the use of medical devices to achieve universal health coverage, respond to health emergencies and keep populations safe. We see companies designing and developing more and more devices and trying to find their way to a market approved status. Among others, this market strategy has to take
Wondering how a typical working day at Quality by Design looks like? In part 2 of our ‘A day in the QbD life of’ blog series, Imrane, Process Engineer, tells us all about his day. Enjoy the read, and of course: if this looks like your cup of tea, don’t
In this blog post, we give more insights into the challenges a QP faces when dealing with ATMPs. We talk about sterility, out-of-specification handling, batch release, and EU import testing.
The sales price of cell and gene therapies is influenced by multiple factors like Cost of Goods (COG), regulatory requirements, target market (or commercial aspect), and the development just to name a few. In this blog post you will learn more about the GOC aspect: what is this cost comprised of and how can you reduce it?
UDI is a new system that assigns a unique barcode to each individual medical device. It will become mandatory when MDR and IVDR enter into force, so as a manufacturer, you need to make sure you’re UDI-ready in time.
During the QbD Corona World Games, our online international team building event, thirteen randomly selected teams defended their honor.
A short introduction and overview of the requirements In 2017, the European Commission released the new Medical Device Regulation (MDR) that will replace the Medical Device Directive (MDD) in May 2021. The regulation has been written to assure better quality and improve the safety aspects for all medical devices that
One of our previous blogposts discussed innovations in the medical technology field and how these can fulfill unmet patients’ and physicians’ needs by leveraging the latest technological advancements. It is undeniable that the future of medical technology looks exciting and, obviously, being innovative requires a lot of specific technological expertise
Do you want to distinguish starting materials used for ATMPs from those used for transplants or transfusions? This distinction is made based on how the starting materials are processed and/or used clinically. We’ve listed the steps to make such a distinction, with the help of a flowchart. Current ATMP workflows
Recently, we announced that Quality by Design and TRIUM Clinical Consulting have joined forces to create an end-to-end offering for the lifecycle of medical products and therapies. A giant leap forward in the growth, expansion and development of both companies. Are you curious as to why TRIUM is the ideal
Among the Advanced Therapy Medicinal Products (ATMPs), in the immunotherapy market, nowadays two acronyms catch the eye: CAR-T and TCR-T. The two techniques are based on the insertion of a specific receptor on the T-cells to enable them to detect and kill the tumor cells specifically. When the receptor is
It’s obvious that product quality and patient safety are a top priority in the pharmaceutical industry. The quality by design methodology is used to build quality into production processes. By a comprehensive understanding of and insight in products and processes, continuous improvement of products and processes is possible. But how
GxP Processes Without question, the impact of GxP processes such as product quality and patient health are at the top of the list when it comes to assessing the risks of a computer system. These are crucial in deciding whether to validate a computerized system. Therefore, experience and end user
What does an automation pyramid entail? An automation pyramid visualises the integrated layers of technology used in manufacturing or industry combined with the level of control. From the bottom, where the production runs on motors, machinery, actuators, sensors and so on, to the top where the process is managed. How
In the first blog we discussed the definitions of validation and computerized systems. Checking the fitness of the system is to check whether the system operates according to the needs of the process for which it is acquired.
Have you read our earlier blogposts about the The importance of a dedicated team and skilled project manager for technology transfers, the factors that can make or break your technology transfer, and the drivers of complexity in tech transfers?
Until now, academia and research-based companies have been the major source of successful ATMP (gene therapy and cell- or tissue-engineered product) developments. Based on their success, pharmaceutical companies are trying
In the first blog we discussed the definitions of validation and computerized systems. Checking the fitness of the system is to check whether the system operates according to the needs of the process for which it is acquired.
Checking your phone to see when you took your last medication? Your watch vibrating and telling you to lay down because you will have a seizure soon, while at the same time notifying your emergency contact with your exact location?
Have you read our earlier blogposts about the factors that can make or break your technology transfer, and the drivers of complexity in tech transfers?
Life sciences enterprises in for example the pharmaceutical, biotechnology and medical devices industry must validate computer systems that have an impact on the product and thus the patient safety. A computer system consists of more than just software and hardware; it includes procedures, processes, equipment, training and much more. In
On the 4th of May, it was the turn of Maaike Tuinsma (Pharmaceutical Consultant at QbD) to give the Biomedical Engineering students of the University of Liège a lecture. Topic of this week: FDA & Medical Devices.
In this blogpost, we will dive into these complexities a little bit more and provide you with some useful tips to minimise the complexity of your tech transfers.
Monday 27 April, the fourth QbD guest lecture was on the agenda for the Biomedical Engineering students of the University of Liège. This time the students were introduced to software as a medical device and validation & qualification by QbD’ers Bart Verlinden and Pieter Smits.
(This blog is part of a series. Want to read the first part? Check it out here) After the Easter holidays, QbD resumed its guest lectures for the biomedical engineering students at the University of Liège. This week, our experienced consultants Jeroen Verhoeven and Steven Vinckx introduced them to the
A technology transfer can take place between buildings on the same production site, between different production plants from the same company or even between different companies. It can involve the transfer of various aspects, such as information, expertise, processes and assets. Thorough understanding between the sending and receiving units is
This blogpost aims to provide useful information for parties involved in the development of face masks in the fight against the COVID-19 pandemic. It lists the impact of the recommendations from the European Commission [1] on the development and distribution of face masks. In general, two types of face masks
Innovation is key to the success of companies and is driving many industries. This is certainly true for the medical technology sector. According to yearly research by the European Patent Organization (EPO) on filings and applications per field of technology, 13.833 med tech patent applications were filed in 2019. Contrary
A hiring freeze during Corona? No way! Although the current crisis has created new and unexpected challenges, QbD is not the kind of company to let these get in the way. In order to keep getting things done for our clients, our HR department is going the extra mile to
As long as the COVID-19 measures are in place, the QbD recruitment team continues to work from home. But thanks to modern technology, and our ‘getting things done’ mentality, it’s business as usual at QbD! Wondering what a working day looks like for our recruiters Tim and Karen? 9.00 am:
Hi! My name is Frederick Tison. I’m 26 years old and this is my third year at QbD. I’m currently active as a raw material specialist for a client. Together with fellow QbD’er Tijs Van Den Berghe, I’m responsible for setting up specifications for the raw materials that are purchased
What is the definition of ATMP? From the website of EMA: Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer ground-breaking new opportunities for the treatment of disease and injury. ATMPs can be classified into three main types: Gene
The next episode in the guest lecture program for the students Biomedical Engineering at the University of Liège was a new experience for both trainers and trainees. Some social distance had to be covered by means of a webinar and some high-end glass fiber internet cabling. From our Kot in
As you know, QbD is a very sporty and healthy organization. Since today is the start of homework and social distancing week 2, we obviously miss our weekly Bootcamp together. But thank god for technology! We were able to set up a Bootcamp via livestream in collaboration with our beloved
There we were, in the ‘quartier Polytech’, looking for the department ‘Aérospatiale & Mécanique’ at the university of Liège. We had gotten up way too early in the morning, but a small holiday feeling at 8 AM on Monday was our reward, as we crossed the language border – Liège
Advanced therapy medicinal products (ATMP) is the group of therapies in which we use cells, genes, engineered tissues and combinations of the above with medical devices as a medicinal product. A medicinal product can be described as: any substance or combination of substances presented as having properties for treating or
Advanced therapy medicinal products (ATMP) are cell and gene therapies that provide new opportunities for the treatment of a variety of diseases and injuries. Due to the specificity and novelty of the ATMP sector, the development of these therapies faces a unique set of challenges. Artificial intelligence (AI), a broad
The past of Computer Systems Validation has served us well and provided us with the foundation of where we are today. But at some point, the past can become a burden. This is exactly the point in time where we have arrived.
As Production Support Engineer I support my client Biocartis with issues associated with the production process. Depending on the problem, it is my job to either involve other departments or to solve it within the department. I also train operators and supervisors and prepare Biocartis for the future, by tackling
The clock is ticking for Brexit. By 31 October 2019, a final agreement on the matter must be reached. There is no doubt that the UK leaving the European Union (EU) will have an enormous impact on the UK and EU member states.
When it comes to the market release of vaccines, there are some specific requirements and legislations that companies need to keep in mind. In this blog post, we will pay attention to the market release of vaccines onto two of the most important markets worldwide: the European Union and the United States of America. Although they are quite similar, there are some interesting differences when it comes to testing, documentation and certification.
It’s time again for a closer look into the daily life of another one of our QbD’ers! Meet Julie Bondroit, one of the members of our amazing HR team at the head office in Wilrijk. Does this sound interesting to you? Don’t hesitate to send us your resume. Hi all!
QbD is known for its team spirit and sporty character. This isn’t only the case at the office, but also outside of work!
s week, it’s pharmacist Evelyne Goudezeune’s turn to bring us along for a typical ‘Day in the QbD Life’, filled with several meetings and a very entertaining evening. Like what you read? Then make sure to send us your cv to join our amazing team
The manufacturing and sale of medicine is big business. As a result, falsified medicines are a serious threat to patients that are dependent of safe and reliable medication. Therefore, many countries have rules and regulations in place to prevent such medicine from entering the supply chain. The approach of the
Time to invade another QbDer’s privacy! In her ‘Day in the QbD life of…’, Lieve De Wolf gives us a closer look into a typical day as QbD employee, filled with challenging work and a healthy dose of joy. Like what you read? Then make sure to send us your
Backed by increasing investments from commercial sponsors, the development of advanced therapy medicinal products (ATMP) is growing strongly in the United Kingdom. For good reason, the country is described as a growing hub for the development and manufacturing of cell and gene therapies. Less well-known is the fact that Belgium
Imagine explaining the use of Excel and all its functions to someone who has never worked with the program before – in a written manual. Where would you start? By explaining how to open the spread sheet program perhaps, followed by the question how to create new documents, formulas or
The qualification and validation group within QbD organized their first Competence Center a few weeks ago. This forum is used to discuss interesting topics concerning qualification and validation in general. As our main topic for 2019, we selected process validation to be the focal point. In three sessions, spread over 2019, the
Los países confían en el uso de productos sanitarios para lograr una cobertura de salud universal, responder a emergencias de salud y mantenerla seguridad de la población. Vemos empresas que diseñan y desarrollan cada vez más y más dispositivos e intentan encontrar su camino hacia la aprobación de comercialización. Entre
Countries rely on the use of medical devices to achieve universal health coverage, respond to health emergencies and keep populations safe. We see companies designing and developing more and more devices and trying to find their way to a market approved status. Among others, this market strategy has to take
Wondering how a typical working day at Quality by Design looks like? In part 2 of our ‘A day in the QbD life of’ blog series, Imrane, Process Engineer, tells us all about his day. Enjoy the read, and of course: if this looks like your cup of tea, don’t
