Use of tumorigenic cells of human origin for the production of biological and biotechnological medicinal products - Scientific guideline
HumanScientific guidelines
This document sets out the current EU regulatory thinking with regard to risk assessment of the purified products derived from tumourigenic cells. It is not legally binding on applicants and may evolve with new scientific developmnets.
Keywords: Biotechnological product, biological product, tumorigenic cell, residual cell DNA