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Guideline on development, production, characterisation and specification for monoclonal antibodies and related products

We have adopted this International Scientific Guideline - EMA/CHMP/BWP/532517/2008.

Last updated

About this guideline

Overseas effective date:  1 September 2016

Replaces: EMEA/CHMP/BWP/157653/2007 Guideline on Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products (adopted by TGA 5 August 2009); and the quality requirements for monoclonal antibodies set out in the guideline a Radiopharmaceuticals Based on Monoclonal Antibodies 3AQ21.

Categories: Biologicals | Active substance | Manufacture and characterisation and control of the active substance.

TGA annotations: Nil

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For more information see International scientific guidelines adopted in Australia.

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