Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Cell-based ATMPs may include:

● Human or animal cells or tissues

● Autologous or allogeneic cells

● Viable or non-viable cells – If non-viable, must act by pharmacological, immunological or metabolic means

● With or without additional substances – biomolecules – scaffolds or matrices

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TOPRA MSc Module 18: Drug Device Combinations and other Technology

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Where do medical devices fit in with ATMPs?

History ● Early tissue engineering products were for wound healing – In US were approved by CDRH as medical devices – Now regulated in US and EU as medicines ● Tissue engineering products often include matrices and structural supports that are medical devices ● Cell and gene therapies often need specialist delivery devices

TOPRA MSc Module 18: Drug Device Combinations and other Technology

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