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Journal Abstract Search

167 related items for PubMed ID: 9413543

  • 1. Strategies to avoid virus transmissions by biopharmaceutic products.
    Werz W, Hoffmann H, Haberer K, Walter JK.
    Arch Virol Suppl; 1997; 13():245-56. PubMed ID: 9413543
    [Abstract] [Full Text] [Related]

  • 2. Transmissible spongiform encephalopathies (TSE): minimizing the risk of transmission by biological/biopharmaceutical products: an industry perspective.
    Kozak RW, Golker CF, Stadler P.
    Dev Biol Stand; 1996; 88():257-64. PubMed ID: 9119148
    [Abstract] [Full Text] [Related]

  • 3. Pathogen safety of manufacturing processes for biological products: special emphasis on KOGENATE Bayer.
    Lee DC, Miller JL, Petteway SR.
    Haemophilia; 2002 Mar; 8 Suppl 2():6-9. PubMed ID: 11966845
    [Abstract] [Full Text] [Related]

  • 4. The clearance of viruses and transmissible spongiform encephalopathy agents from biologicals.
    Farshid M, Taffs RE, Scott D, Asher DM, Brorson K.
    Curr Opin Biotechnol; 2005 Oct; 16(5):561-7. PubMed ID: 16095899
    [Abstract] [Full Text] [Related]

  • 5. Determination of the clearance factor for transmissible spongiform encephalopathy agents during the manufacturing process of polygeline.
    Peano S, Reiner G, Carbonatto M, Bodenbender L, Boland P, Abel KJ.
    Intensive Care Med; 2000 May; 26(5):608-12. PubMed ID: 10923737
    [Abstract] [Full Text] [Related]

  • 6. Overview of the nonclinical quality and toxicology testing for recombinant biopharmaceuticals produced in mammalian cells.
    Lebrec H, Narayanan P, Nims R.
    J Appl Toxicol; 2010 Jul; 30(5):387-96. PubMed ID: 20589744
    [Abstract] [Full Text] [Related]

  • 7. An overview of bovine spongiform encephalopathy.
    Kimberlin RH.
    Dev Biol Stand; 1991 Jul; 75():75-82. PubMed ID: 1838995
    [Abstract] [Full Text] [Related]

  • 8. Opinion of the EMEA on the potential risk associated with medicinal products in relation to bovine spongiform encephalopathy (BSE) (16 April 1996) and report from the Committee for Proprietary Medicinal Products (CPMP) on the 'Note for Guidance on minimizing the risk of transmitting animal spongiform encephalopathies via medicinal products' (15 April 1997).
    Adverse Drug React Toxicol Rev; 1997 Jun; 16(2):113-21. PubMed ID: 9359933
    [No Abstract] [Full Text] [Related]

  • 9. Gelatine production, the six steps to maximum safety.
    Schrieber R, Seybold U.
    Dev Biol Stand; 1993 Jun; 80():195-8. PubMed ID: 8270109
    [Abstract] [Full Text] [Related]

  • 10. Safety of biological products prepared from mammalian cell culture. Bovine spongiform encephalopathy and other non-viral transmissible agents.
    Dev Biol Stand; 1998 Jun; 93():133-4. PubMed ID: 9737391
    [No Abstract] [Full Text] [Related]

  • 11. Opportunities and challenges of real-time release testing in biopharmaceutical manufacturing.
    Jiang M, Severson KA, Love JC, Madden H, Swann P, Zang L, Braatz RD.
    Biotechnol Bioeng; 2017 Nov; 114(11):2445-2456. PubMed ID: 28710854
    [Abstract] [Full Text] [Related]

  • 12. Evolution of approaches to viral safety issues for biological products.
    Lubiniecki AS.
    PDA J Pharm Sci Technol; 2011 Nov; 65(6):547-56. PubMed ID: 22294576
    [Abstract] [Full Text] [Related]

  • 13. Adventitious agents from animal-derived raw materials--a method of risk assessment.
    Foster LG.
    Dev Biol Stand; 1996 Nov; 88():283-90. PubMed ID: 9119152
    [Abstract] [Full Text] [Related]

  • 14. Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing.
    Barone PW, Avgerinos S, Ballard R, Brussel A, Clark P, Dowd C, Gerentes L, Hart I, Keumurian FJ, Kindermann J, Leung JC, Ly N, Mink S, Minning S, Mullberg J, Murphy M, Nöske K, Parriott S, Shum B, Wiebe ME, Springs SL.
    PDA J Pharm Sci Technol; 2019 Nov; 73(2):191-203. PubMed ID: 30361281
    [Abstract] [Full Text] [Related]

  • 15. Examination of the biological safety of a drug derived from mammalian organs.
    Hübner GE, Koch RC, Sprenger KB, Stadler PJ, Gölker CF.
    Arzneimittelforschung; 1996 Jun; 46(6):657-61. PubMed ID: 8767361
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