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ATMPs - translating the expertise into a GMP process - QbD

ATMPs: translating the expertise into a GMP process

In the field of regenerative medicine, advanced therapy medicinal products (ATMPs) represent the next generation of medicines. It is, however, not so straightforward to translate this new expertise into a GMP process. In this article, you’ll learn more about the challenges and crucial aspects.

QbD & TRIUM 10Y International Sports Challenge - 9

QbD & TRIUM’s 10Y International Sports Challenge: a mix of fun, exercise, and team spirit!

Sports, competitiveness, team spirit, joy and social responsibility have always been an essential part of QbD and TRIUM’s DNA. So – to celebrate both our 10-year anniversaries – we came up with an exciting event combining all of these values: our 10Y International Sports Challenge!
For four weeks – from 14/06 until 11/07 – we put our best foot forwards to complete the challenge and had a blast. Read all about it below!

Is your product a medical device Well, that depends… - QbD

Is your product a medical device? Well, that depends…

The “funny” thing about bringing medical devices to market is that you first must ask yourself… whether your product IS a medical device or not, as well as in which countries it is and in which countries it is not. If your product is classified as a medical device, then it might be subject to constraints. On the other hand, your product might be or be perceived as more valuable, more safe, more performant to customers. Most of the time, however, the choice is not up to manufacturers. All depends on the market(s) you want to reach. Definitions vary from country to country, as do regulations. In this blog post, we will help you answer that one important question by sharing a brief overview of important regulations, their similarities, and their differences.

How QbD is investing in the new hybrid way of working - Quality by Design

How QbD is investing in the new hybrid way of working

Now that it seems like we’re finally taming the COVID beast, many companies are preparing to make the switch to ‘hybrid working’: combining working from home with going back to the office. This concept, however, is not as self-explanatory as you may think. How do we make sure our people work as comfortably at home as they did at the office? Which types of tasks are we going to perform at home and which ones at the office, with efficiency and well-being in mind? And which role does the office still have to play in all of this? At QbD, we’re going the extra mile to put the new way of working to everyone’s advantage. If you need some inspiration, just follow our lead.

Clinical Trials for ATMPs which challenges to overcome - Quality by Design (1)

Clinical Trials for ATMPs: which challenges to overcome?

ATMPs are, by nature, highly complex and innovative therapies. And well-designed clinical trials are key to producing effective and safe ATMPs – ultimately increasing patients’ health and speeding up market authorization. In this blogpost, Marie-Paule Gyselen from TRIUM Clinical Consulting (part of the QbD Group) guides you through the most important ATMP-specific clinical trial challenges.

From idea to post market surveillance: the phases of the medical device lifecycle

Launching a medical device requires much preparation. As these devices are heavily regulated, a company has to meet many requirements in different phases of the development and manufacturing process. Which phases are there to consider and what are their characteristics? This blog digs deeper into the lifecycle of a medical device and requirements that must be met in those phases.

How do you reduce the Cost of Goods, which is key to affordable ATMPs?

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?

Post-Market Surveillance of Medical Devices

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

Medical devices: innovations versus regulations

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

CAR T and TCRs for the market: current state and future perspectives

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

Quality by design methodology for the pharmaceutical industry

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

QbD product quality main pillars

What to focus on when validating a computer system? (3)

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

QbD pyramid corporate levels

Automation Pyramid – FAQ

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

technology transfer by quality by design

Three important trends in technology transfers

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?

How to start with computer system validation?

What to focus on when validating a computer system

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.

How to start with computer system validation?

How to start with computer system validation?

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

jeroen CE-marking roadmap

RA/QA guest lectures – week 3 – Roadmap to CE-marking

(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

technology transfer by quality by design

These factors can make or break your technology transfer

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

Development of face masks in the fight against the COVID-19 pandemic

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

Evolution medical, technology and innovation patents

Innovations in Medical Technology: The Future of Healthcare is Data

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

Videochat QbD recruitment team during COVID19

A day in the life of… our QbD recruitment team

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:

Frederick Tison in Bike outfit

A Day in the QbD life of… Frederick Tison – Corona times

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

QbD: a quality-focused process development roadmap for ATMPs

Anything you need to know about ATMPs: FAQ

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

steven vincks regulatory and quality lecture

RA/QA lectures at the University of Liège – week 2

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

Following excercie on video

Sweating out the Monday blues: via livestream this time!

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

QbD offices

Artificial Intelligence in Advanced Therapy Medicinal Products

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

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ATMPs - translating the expertise into a GMP process - QbD

ATMPs: translating the expertise into a GMP process

In the field of regenerative medicine, advanced therapy medicinal products (ATMPs) represent the next generation of medicines. It is, however, not so straightforward to translate this new expertise into a GMP process. In this article, you’ll learn more about the challenges and crucial aspects.

QbD & TRIUM 10Y International Sports Challenge - 9

QbD & TRIUM’s 10Y International Sports Challenge: a mix of fun, exercise, and team spirit!

Sports, competitiveness, team spirit, joy and social responsibility have always been an essential part of QbD and TRIUM’s DNA. So – to celebrate both our 10-year anniversaries – we came up with an exciting event combining all of these values: our 10Y International Sports Challenge!
For four weeks – from 14/06 until 11/07 – we put our best foot forwards to complete the challenge and had a blast. Read all about it below!

Is your product a medical device Well, that depends… - QbD

Is your product a medical device? Well, that depends…

The “funny” thing about bringing medical devices to market is that you first must ask yourself… whether your product IS a medical device or not, as well as in which countries it is and in which countries it is not. If your product is classified as a medical device, then it might be subject to constraints. On the other hand, your product might be or be perceived as more valuable, more safe, more performant to customers. Most of the time, however, the choice is not up to manufacturers. All depends on the market(s) you want to reach. Definitions vary from country to country, as do regulations. In this blog post, we will help you answer that one important question by sharing a brief overview of important regulations, their similarities, and their differences.

How QbD is investing in the new hybrid way of working - Quality by Design

How QbD is investing in the new hybrid way of working

Now that it seems like we’re finally taming the COVID beast, many companies are preparing to make the switch to ‘hybrid working’: combining working from home with going back to the office. This concept, however, is not as self-explanatory as you may think. How do we make sure our people work as comfortably at home as they did at the office? Which types of tasks are we going to perform at home and which ones at the office, with efficiency and well-being in mind? And which role does the office still have to play in all of this? At QbD, we’re going the extra mile to put the new way of working to everyone’s advantage. If you need some inspiration, just follow our lead.

Clinical Trials for ATMPs which challenges to overcome - Quality by Design (1)

Clinical Trials for ATMPs: which challenges to overcome?

ATMPs are, by nature, highly complex and innovative therapies. And well-designed clinical trials are key to producing effective and safe ATMPs – ultimately increasing patients’ health and speeding up market authorization. In this blogpost, Marie-Paule Gyselen from TRIUM Clinical Consulting (part of the QbD Group) guides you through the most important ATMP-specific clinical trial challenges.

From idea to post market surveillance: the phases of the medical device lifecycle

Launching a medical device requires much preparation. As these devices are heavily regulated, a company has to meet many requirements in different phases of the development and manufacturing process. Which phases are there to consider and what are their characteristics? This blog digs deeper into the lifecycle of a medical device and requirements that must be met in those phases.

How do you reduce the Cost of Goods, which is key to affordable ATMPs?

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?

Post-Market Surveillance of Medical Devices

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

Medical devices: innovations versus regulations

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

CAR T and TCRs for the market: current state and future perspectives

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

Quality by design methodology for the pharmaceutical industry

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

QbD product quality main pillars

What to focus on when validating a computer system? (3)

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

QbD pyramid corporate levels

Automation Pyramid – FAQ

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

technology transfer by quality by design

Three important trends in technology transfers

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?

How to start with computer system validation?

What to focus on when validating a computer system

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.

How to start with computer system validation?

How to start with computer system validation?

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

jeroen CE-marking roadmap

RA/QA guest lectures – week 3 – Roadmap to CE-marking

(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

technology transfer by quality by design

These factors can make or break your technology transfer

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

Development of face masks in the fight against the COVID-19 pandemic

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

Evolution medical, technology and innovation patents

Innovations in Medical Technology: The Future of Healthcare is Data

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

Videochat QbD recruitment team during COVID19

A day in the life of… our QbD recruitment team

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:

Frederick Tison in Bike outfit

A Day in the QbD life of… Frederick Tison – Corona times

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

QbD: a quality-focused process development roadmap for ATMPs

Anything you need to know about ATMPs: FAQ

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

steven vincks regulatory and quality lecture

RA/QA lectures at the University of Liège – week 2

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

Following excercie on video

Sweating out the Monday blues: via livestream this time!

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

QbD offices

Artificial Intelligence in Advanced Therapy Medicinal Products

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