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Related Experiment Videos

[Technology optimization and properties study of factor IV complex concentrates].

Rong Zeng1, Rong Yu, Xiaohong Li

  • 1Department of Biopharmaceutics, West China School of Pharmacy, Sichuan University, Chengdu 610041, China.

Sichuan Da Xue Xue Bao. Yi Xue Ban = Journal of Sichuan University. Medical Science Edition
|December 17, 2004
PubMed
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Domestic ion exchangers can effectively produce high-quality factor IX complex concentrates, matching the performance of foreign counterparts. This advancement offers a reliable domestic source for essential hemophilia treatments.

Area of Science:

  • Biochemistry
  • Hematology
  • Biotechnology

Context:

  • Factor IX complex concentrates are crucial for treating hemophilia B.
  • Current production methods often rely on imported materials.
  • Developing domestic alternatives is vital for supply chain security and cost-effectiveness.

Purpose:

  • To evaluate the efficacy of a domestically produced ion exchanger (DEAE-Sepharose fast flow) for manufacturing factor IX complex concentrates.
  • To compare the quality and recovery of factor IX concentrates produced using domestic versus foreign ion exchange chromatography.
  • To assess the purity and thrombogenicity of the newly developed concentrate.

Summary:

  • A novel method utilizing domestic DEAE-Sepharose fast flow ion exchange chromatography and Ca3(PO4)2 adsorption was employed to produce human solvent-detergent treated factor IX complex concentrates.

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  • The domestic process achieved high activity recovery (93.67% +/- 2.56%) and specific activity (7.36 U Factor IX:C/mg protein).
  • The resulting concentrates demonstrated higher purity and lower thrombogenicity compared to those produced with a foreign ion exchanger.

    • Impact:

    • Establishes the feasibility of using domestic ion exchangers for producing high-quality factor IX complex concentrates.
    • Provides a potential pathway for reducing reliance on imported materials in hemophilia treatment.
    • Contributes to the development of more accessible and affordable hemophilia therapies.