Safety aspects in the manufacturing of plasma-derived coagulation factor concentrates

研究成果: 雜誌貢獻回顧型文獻

34 引文 斯高帕斯(Scopus)

摘要

Plasma-derived coagulation factor concentrates, prepared using traditional manufacturing processes, have transmitted viral diseases, especially AIDS, hepatitis B and hepatitis C to patients. To date, more extensive selection of blood donors, improved screening procedures of each plasma donation for direct and indirect viral markers, and newly developed virucidal procedures, especially pasteurization and solvent-detergent, together with extraction technologies of plasma proteins based on high-resolution chromatographic separations, have diminished considerably the risks of transmitting these pathogenic agents. To ensure safety, each production process must be carefully validated, following a rigorous scientific approach to assess its ability to inactivate or eliminate viruses. In addition, Good Manufacturing Practices must avoid any variation from these validated viral inactivation processes and must eliminate risks of potential downstream contamination of purified plasma fractions following viral inactivation or elimination steps. Other side-effects associated with conventional low-purity preparations, such as acute haemolytic anemia due to contamination by isohaemagglutinins, or immunosuppression possibly due to an overload in fibrinogen and immunoglobulins, have not been reported following infusion of highly purified coagulation factor concentrates. Present state-of-the-art virus inactivation and protein-purification technologies have significantly improved the safety of plasma coagulation factor concentrates.
原文英語
頁(從 - 到)91-100
頁數10
期刊Biologicals
20
發行號2
DOIs
出版狀態已發佈 - 1992
對外發佈Yes

    指紋

ASJC Scopus subject areas

  • Biotechnology
  • Bioengineering
  • Immunology and Microbiology(all)
  • Applied Microbiology and Biotechnology
  • Pharmacology
  • Immunology
  • Microbiology
  • Infectious Diseases

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