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Get insights from different stakeholders on specific ATMP topics.
GMP Audit Checklist for Raw Materials and Suppliers Qualification in ATMP Manufacturing
When manufacturing an ATMP it is important to pay attention to the choice of raw materials used. These materials influence the entire process, from IMPD to market authorization. Good Manufacturing Practice (GMP) guidelines contain important considerations, but what does this mean in practice for the ATMP manufacturer? How to take into account the origin, traceability and composition of the raw materials? How to collaborate with a supplier in the audit process of these raw materials? at.las, anicells and eyetec are pleased to offer you a GMP audit checklist for the qualification of suppliers and their products. This GMP audit checklist is the result of a workshop with experts, held in May 2023. You can download the checklist after logging in on the at.las academy website or you can ask a copy by sending a mail to info@advancedtherapies.com.
ATMP: Belgian legislation at a glance
Marc Martens elaborates on an important milestone set in the Belgian Advanced Therapy Medicinal Products (“ATMP”) legislation. On October 20th 2018, a modification of the law of December 19th 2008, regarding the collection and use of human body material for the purpose of human therapeutic applications or scientific research, was published. This modification enables progress in the development of new, innovative therapies based upon the handling of human cells and tissues for the production of medicines.
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Clinical development & ATMP's : an interview with QbD and Venn Life Sciences
The (pre)clinical development process is complex and risky. This is especially true for ATMP. Luckily, expert organisations are able to deliver strategic support as well as operational capabilities. We have invited at.las members Quality by Design and Venn Life Sciences to share their view on the ATMP development process and give insight into their experiences. A double-interview with Dominiek Rossillion (Quality by Design) and Bruno Speder (Venn Life Sciences).
Digitalization: Is it Worth It?
As with other drug molecules, ATMP’s have to comply to the Good Manufacturing Practice (GMP) guidelines, which require the meticulous assessment of both quality and consistency of the end product. This needs a careful monitoring of the entire manufacturing process, which is both a challenge and an opportunity for the ATMP field. Investing in efficient, innovative, reliable, automated, digitally monitored processes, will position ATMP as a frontrunner within the pharmaceutical sector, attracting additional funding and making way for improvements in other product areas. Yet, contrary to what one might expect, developers today are often not embracing automation or even digital transformation. A quick survey of developers indicates 3 main hurdles with regard to digitalized monitoring and record keeping. In this article, we take a closer look.