• Animals

    Good Clinical PracticeUse of transgenic animals in the manufacture of biological medicinal products for human use

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  • Biosimilar

    BiosimilarGuideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues

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  • Biotech

    BiotechNote for guidance on quality of biotechnological products: derivation and characterisation of cell substrates used for production of biotechnological/biological products

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  • Cytokine

    Cytokine Production and quality control of cytokine products derived by biotechnological processes

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