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    In vitro adventitious virus test using Simian (Vero), Human (MRC-5) and cells of the same species and tissue type as the production cells. In vivo test in adult and suckling mice and embryonated chickens eggs. Tests for Retroviruses including PERT (following EP 2.6.21), Transmission Electron Microscopy, Infectivity assays i.e. PG4 S+Lor cocultvation Sterility conforms to

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    In vitro adventitious virus test using Simian (Vero), Human (MRC-5) and cells of the same species and tissue type as the production cells. In vivo test in adult and suckling mice and embryonated chickens eggs. Tests for Retroviruses including PERT (following EP 2.6.21), Transmission Electron Microscopy, Infectivity assays i.e. PG4 S+Lor cocultvation Sterility conforms to

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    44 views1 page

    BioOutsource Biologics Biosafety Testing

    Uploaded by

    Axiaer Solutions
    In vitro adventitious virus test using Simian (Vero), Human (MRC-5) and cells of the same species and tissue type as the production cells. In vivo test in adult and suckling mice and embryonated chickens eggs. Tests for Retroviruses including PERT (following EP 2.6.21), Transmission Electron Microscopy, Infectivity assays i.e. PG4 S+Lor cocultvation Sterility conforms to

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    Biologics testing in Europe

    EMEA ICH Guidelines CPMP/ICH/295/95/ICH Topic Q5A CPMP/ICH/294/95/ICH Topic Q5D CHMP/BWP/157653/07 EMEA/CHMP/BWP/398498/05

    Characterisation of MCB 3AB2A CPMP/ICH/139/95 ICH Topic Q5B CPMP/BWP/1143/00

    Characterisation of Bulk Harvests

    Final Product Testing CPMP/ICH/365/96 ICH Topic Q6B

    Master Cell Bank

    Working Cell Bank

    End of Production Bank

    Morphology - light microscope observations Identity DNA Fingerprinting Sterility conforming to EP 2.6.1 Mycoplasma test which complies with EP 2.6.7 in vitro adventitious virus test using Simian (Vero), Human (MRC-5) and cells of the same species and tissue type as the production cells, (14 day assay in the case of non-primate cells, 28 day assay for primate cells) in vivo adventitious virus test in adult and suckling mice and embryonate chickens eggs (may also include Guinea Pigs where appropriate) Species specific tests inc. Bovine and Porcine viruses (CPMP/BWP/1793/02) Tests for Retroviruses including PERT (following EP 2.6.21), Transmission Electron Microscopy, Infectivity assays i.e. PG4 S+L- or cocultvation

    Morphology light microscope observations Identity DNA Fingerprinting Sterility conforms to EP 2.6.1 Mycoplasma test which complies with EP 2.6.7

    Morphology light microscopic observations Identity DNA Fingerprinting Sterility conforms to EP 2.6.1 Mycoplasma test (EP 2.6.7) in vitro adventitious virus test using Simian (Vero), Human (MRC-5)and cells of the same species and tissue type as the production cells in vivo test in adult and suckling mice and embryonated chickens eggs Tests for Retroviruses including PERT (following EP 2.6.21), Transmission Electron Microscopy, Intfectivity assays i.e. PG4 S+L- or cocultvation

    Sterility conforms to EP 2.6.1 or Bioburden conforming to EP 2.6.12 Mycoplasma complies with EP 2.6.7 or EP 2.6.21 in vitro adventitious virus testing MRC-5, Vero and cell line of the same species and tissue type as the production cell line (14 day assay in the case of non-primate cells, 28 day assay for primate cells) Tests for Retroviruses including PERT (following EP 2.6.21), Transmission Electron Microscopy, Infectivity assays Tests for species specific testing i.e. Mouse minute virus or Cache Valley virus Once only in vivo adventitious virus testing in adult and suckling mice and embryonated chickens eggs (may also include Guinea Pigs where appropriate)

    Sterility conforming to EP 2.6.1 pH conforms to EP 2.2.3 Visible and sub-visible particles conforming to EP 2.9.19 Extractable volume conforms to EP 2.9.17 Bacterial endotoxins conforms to EP 2.6.14 Total proteins conforming to EP 2.5.33 Residual Host cell DNA Residual Host cell Protein Characterisation of product Molecular distribution SEC HPLC conforming to EP 2.2.10 Purity Gel Electrophoresis conforming to EP 2.2.30. Product Potency - in vivo or in vitro assay following EP section 5.3 (Biological Activity per mass unit) (CHMP/BWP/271475/06) Appearance conforming to EP 2.2.2 Osmolality conforms to EP 2.2.35 Product specific Testing requirement

    BioOutsource Ltd Units 3/4 Technology Terrace Todd Campus West of Scotland Science Park Glasgow G20 0XA tel: +44 (0)141 946 4222 email: info@biooutsource.com web: www.biooutsource.com

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