Quality of biological active substances produced by transgene expression in animals - Scientific guideline
HumanScientific guidelines
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
AdoptedReference Number: EMA/CHMP/BWP/151897/2013Legal effective date: 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.
English (EN) (151.37 KB - PDF)
First published: Last updated:
Document history - First version (current)
Guideline on quality of biological active substances produced by transgene expression in animals
AdoptedReference Number: EMA/CHMP/BWP/151897/2013Legal effective date: 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.
English (EN) (151.37 KB - PDF)
First published: Last updated:
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
English (EN) (114.31 KB - PDF)
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Draft guideline on quality of biological active substances produced by transgene expression in animals
Draft: consultation closedConsultation dates:
to Reference Number: EMA/CHMP/BWP/159188/2012Summary:
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.
English (EN) (189.6 KB - PDF)
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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:
to Reference Number: EMEA/CHMP/BWP/134153/2009
English (EN) (34.39 KB - PDF)
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Document history - Superseded document
Use of transgenic animals in the manufacture of biological medicinal products for human use
AdoptedReference Number: III/3612/93Legal effective date:
English (EN) (41.59 KB - PDF)
First published: Last updated:
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