Drug Regulators, EMEA, Publish Guidline on Xenogenic Cell-Based Medicinal Products

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Xenogeneic cell-based therapy is the use of viable animal somatic cell preparations, suitably adapted for: (a) implantation/ infusion into a human recipient or (b) extracorporeal treatment through bringing (non-human) animal cells into contact with human body fluids, tissues or organs. The principal objective is reconstitution of cell/tissue/organ functions. The genotype and/or phenotype of the cells may have been modified, e.g. by isolation, culture, expansion, pharmacological treatment or
combination with various matrices. This guideline is an annex to the guideline on cell-based medicinal products (EMEA/CHMP/410869/2006) and deals specifically with requirements unique to xenogeneic specificities. This document is intended to provide general principles to be taken into consideration for the development and assessment of xenogeneic cell-based products without prejudice to medical practice or national legislation, which may be applicable. The main scientific and technical issues identified so far concern the sourcing and testing of animals, manufacture, quality control, as well as the non-clinical and clinical development of xenogeneic cellbased medicinal products are addressed. Relevant public health aspects are discussed and measures to ensure a proper surveillance for infections, including zoonoses are highlighted. These general
principles may apply to a range of products using animal tissues as the starting material, as the key objective is to ensure that the product to be administered is of acceptable quality and standard, and free from contamination.
The additional risks associated with xenogeneic cell-based Medicinal Products should be taken into account in the clinical development of these products. Attention is also given to principles of animal health and welfare in the processes of sourcing of xenogeneic materials for the medicinal products intended for human use.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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