EMA Guideline on Quality of biological active Substances produced by transgene Expression in Animals

In May 2013 the CHMP adopted the Guideline on Quality of biological active substances produced by transgene expression in animals. The date for coming into effect is the 1 December 2013. It will replace the guideline on ‘Use of transgenic animals in the manufacture of biological medicinal products for human use’

Transgenic animal technology has emerged as a complement to the longer-established range of prokaryotic, yeast and mammalian cell-based recombinant protein expression systems for the production of therapeutic proteins. This document provides guidance on the approaches that should be employed to achieve satisfactory quality for biological active substances proposed to be produced using this technology.

The principal aim of this guideline is to adapt some specific aspects of the quality guidance already in place for other recombinant production systems to the special case of transgenic animal systems. As is the case with other biotechnologically produced active substances, both the production process and its control strategy play important roles in defining the quality profile of active substances produced by transgenic animals.