Xenogeneic cell-based medicinal products - Scientific guideline
HumanAdvanced therapiesScientific guidelines
This document addresses the scientific requirements for medicinal products that contain viable animal cells or tissues as an active substance (xenogeneic cell-based medicinal products). It provides general principles for the development and assessment of xenogeneic cell-based products without prejudice to medical practice or national legislation, which may be applicable.
Keywords: Xenogeneic, cell therapy, quality, nonclinical, clinical, transgenic animals