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A pasteurized antithrombin III concentrate for clinical use.

J K Smith, L Winkelman, D R Evans

    Vox Sanguinis
    |January 1, 1985
    PubMed
    Summary
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    A new method for large-scale production of pasteurized antithrombin III (AT III) concentrate was developed. This safe and effective AT III concentrate is suitable for treating congenital deficiencies.

    Area of Science:

    • Biochemistry
    • Biotechnology
    • Hematology

    Background:

    • Antithrombin III (AT III) is crucial for regulating coagulation.
    • Congenital deficiencies in AT III increase thrombotic risk.
    • Therapeutic AT III concentrates are needed for managing these deficiencies.

    Purpose of the Study:

    • To adapt and optimize a method for large-scale production of pasteurized antithrombin III concentrate.
    • To ensure the safety and efficacy of the produced AT III concentrate for therapeutic use.

    Main Methods:

    • Plasma depleted of cryoprecipitate and prothrombin complex was used.
    • Batchwise adsorption onto heparin-Sepharose followed by high salt concentration elution.
    • Pasteurization at 60°C for 10 hours with citrate, desalting, sterile filtration, and freeze-drying.

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    Main Results:

    • A mean yield of 269 U AT III/kg plasma was achieved across seven batches.
    • The concentrate successfully passed all standard animal safety and pyrogenicity tests.
    • The product demonstrated successful therapeutic application in patients with congenital deficiencies.

    Conclusions:

    • The adapted method allows for large-scale, safe production of pasteurized AT III concentrate.
    • This concentrate is a viable therapeutic option for individuals with congenital AT III deficiencies.
    • The production process ensures a high-quality product suitable for clinical use.