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Related Experiment Videos

The manufacturing process for recombinant factor IX

S Harrison1, S Adamson, D Bonam

  • 1Genetics Institute, Inc, Andover, MA 01810, USA.

Seminars in Hematology
|June 13, 1998
PubMed
Summary
This summary is machine-generated.

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Highly purified recombinant factor IX (rFIX) is now available for hemophilia B treatment. This consistent, high-purity rFIX product is manufactured without blood products, offering a reliable therapeutic option.

Area of Science:

  • Biotechnology
  • Biopharmaceutical Manufacturing
  • Hematology

Background:

  • Recombinant DNA technology enables production of therapeutic proteins.
  • Factor IX is essential for blood coagulation and its deficiency causes hemophilia B.
  • Plasma-derived factor IX carries risks of viral transmission.

Purpose of the Study:

  • To describe the manufacturing process and characteristics of a novel recombinant factor IX (rFIX) product.
  • To demonstrate the consistency, purity, and activity of the rFIX product.
  • To establish rFIX as a safe and effective treatment for hemophilia B.

Main Methods:

  • Stable insertion of factor IX and PACE-SOL genes into Chinese hamster ovary cells.
  • Selection of high-expressing cell lines for bioreactor cultivation in defined media.

Related Experiment Videos

  • Purification using four independent chromatography steps without monoclonal antibodies.

    • Main Results:

    • A highly purified and active rFIX product was consistently manufactured.
    • Specific activity of the rFIX product was high (276+/-23 IU/mg).
    • Sixty-five consecutive batches across five campaigns demonstrated product consistency.

    Conclusions:

    • Recombinant factor IX (rFIX) is a consistent, high-purity therapeutic option.
    • The manufacturing process ensures a reliable supply of rFIX for hemophilia B patients.
    • rFIX offers an alternative to plasma-derived factor IX, reducing potential risks.