Quality of biological active substances produced by transgene expression in animals - Scientific guideline

This document addresses the use of transgenic animals as a manufacturing technology for the production of recombinant therapeutic proteins. Guidance is provided on the approaches that should be employed in order to achieve satisfactory quality for biological active substances to be produced using this technology.

Keywords: Transgenic animals, recombinant protein, matrix

Current effective version

Guideline on quality of biological active substances produced by transgene expression in animals

Adopted Reference Number: EMA/CHMP/BWP/151897/2013 Legal effective date: 01/12/2013 Summary:

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.

Document history - First version (current)

Guideline on quality of biological active substances produced by transgene expression in animals

Adopted Reference Number: EMA/CHMP/BWP/151897/2013 Legal effective date: 01/12/2013 Summary:

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.

Overview of comments received on 'guideline on quality of biological active substances produced by transgene expression in animals'

Reference Number: EMA/CHMP/BWP/151908/2013

Draft guideline on quality of biological active substances produced by transgene expression in animals

Draft: consultation closed Consultation dates: 31/05/2012 to 30/11/2012 Reference Number: EMA/CHMP/BWP/159188/2012 Summary:

This guideline provides guidance on the approaches that should be employed in order to achieve satisfactory quality for biological drug substances proposed to be produced using transgenic animal technology. Its principal aim 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.

Concept paper on the need to revise the guideline on the use of transgenic animals in the manufacture of biological medicinal products for human use (3ab7a of July 1995)

Consultation dates: 25/06/2009 to 30/09/2009 Reference Number: EMEA/CHMP/BWP/134153/2009

Document history - Superseded document

Use of transgenic animals in the manufacture of biological medicinal products for human use

Adopted Reference Number: III/3612/93 Legal effective date: 31/07/1995