• Plant

    Plant Guideline on the quality of biological active substances produced by stable transgene expression in higher plants

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  • MAb

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

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  • Immunoglobulin

    Immunoglobulin Note for guidance on production and quality control of animal immunoglobulins and immunosera for human use

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  • Gene Transfer

    Gene Transfer Note for guidance on the quality, preclinical and clinical aspects of gene transfer medicinal products

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