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Why NK Cells are a major breakthrough in the field of ATMPs - QbD

Why NK cells are a major breakthrough in the field of ATMPs

NK cells, as part of our innate immune system, are very effective in killing different types of cells, including tumor cells. Because of these properties, they become very interesting as ATMPs for immunotherapy.

Curious about the potential of NK cells and NK-cell-based immunotherapy? Learn all about them here, including the benefits and challenges.

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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.

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Why NK Cells are a major breakthrough in the field of ATMPs - QbD

Why NK cells are a major breakthrough in the field of ATMPs

NK cells, as part of our innate immune system, are very effective in killing different types of cells, including tumor cells. Because of these properties, they become very interesting as ATMPs for immunotherapy.

Curious about the potential of NK cells and NK-cell-based immunotherapy? Learn all about them here, including the benefits and challenges.

Read More »
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.

Read More »

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

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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

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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

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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

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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

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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

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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

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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

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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:

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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

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