Advanced Therapy Medicinal Products (ATMPs)


ATMPs manufacturing and testing is a complex and fragmented process with large interdependencies where one assay, one assessment or one product can be involved at multiple steps of the ATMP development process, and therefore be submitted to various regulatory requirements.

In addition, this field is young (or at least younger that the other drug modalities) and ATMPs are also globally more personalized than small and large molecules therapeutics.  This means that the analytical assay suite for ATMPs is neither standard nor carved in stone and basically it must be designed “a la carte” for every ATMP compound entering the drug development process.

This of course creates some challenges for the drug developers, especially in an environment where activities are outsourced to external partners.

These are these various considerations and challenges that Lydia Michaut, CSO at the TATAA Biocenter, and Matthew Hewitt, Executive Director, Scientific Solutions Cell & Gene Therapy at Charles River, discussed yesterday during the Advanced Therapy Medicinal Products world series .

Here’s a link to the recording
‘Chapter 4 – Matthew Hewitt’ – 3:00


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