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Journal Abstract Search

136 related items for PubMed ID: 9119122

  • 1. Use of a statistical strategy to evaluate sources of variability in viral safety experiments for a recombinant biopharmaceutical.
    McAllister PR, Shadle PJ, Smith TM, Scott RG, Lubiniecki AS.
    Dev Biol Stand; 1996; 88():111-21. PubMed ID: 9119122
    [No Abstract] [Full Text] [Related]

  • 2. Process evaluation for biopharmaceuticals: what is appropriate in process evaluation?
    Lubiniecki AS, McAllister PR, Smith TM, Shadle PJ.
    Dev Biol Stand; 1996; 88():309-15. PubMed ID: 9119154
    [No Abstract] [Full Text] [Related]

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  • 4. Safety of biological products prepared from mammalian cell culture. In-process testing for viral agents.
    Dev Biol Stand; 1998; 93():130-1. PubMed ID: 9737389
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  • 5. Process scale considerations in evaluation studies and scale-up.
    Walter JK, Werz W, Berthold W.
    Dev Biol Stand; 1996; 88():99-108. PubMed ID: 9119169
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  • 6. Avoiding viral contamination in biotechnological and pharmaceutical processes.
    Henzler HJ, Kaiser K.
    Nat Biotechnol; 1998 Nov; 16(11):1077-9. PubMed ID: 9831040
    [No Abstract] [Full Text] [Related]

  • 7. Future development of harmonized guidelines.
    Hayakawa T.
    Dev Biol Stand; 1996 Nov; 88():331-2. PubMed ID: 9119158
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  • 8. Philosophy and goals of validation for biotech products and the relevance of scale.
    Hageman TC.
    Dev Biol Stand; 1992 Nov; 76():231-7. PubMed ID: 1478341
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  • 16. Licensing of protein products from the milk of transgenic animals. Validation for pathogen removal--a strategy.
    Wright G, Colman A, Cottom D, Williams M.
    Dev Biol Stand; 1996 Nov; 88():269-76. PubMed ID: 9119150
    [No Abstract] [Full Text] [Related]

  • 17. European Regulatory guidance on virus safety of recombinant proteins, monoclonal antibodies and plasma derived medicinal products.
    Celis P, Silvester G.
    Dev Biol (Basel); 2004 Nov; 118():3-10. PubMed ID: 15645667
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  • 18. Experiences of virus, retrovirus and retrovirus-like particles in Chinese hamster ovary (CHO) and hybridoma cells used for production of protein therapeutics.
    Adamson SR.
    Dev Biol Stand; 1998 Nov; 93():89-96. PubMed ID: 9737383
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  • 19. Applicability of statistical reliability methods to the validation process.
    Koch GG.
    Dev Biol Stand; 1992 Nov; 76():225-9. PubMed ID: 1478340
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  • 20. Safety of biological products prepared from mammalian cell culture. Host-cell proteins.
    Dev Biol Stand; 1998 Nov; 93():139-40. PubMed ID: 9737394
    [No Abstract] [Full Text] [Related]

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