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Solvent/detergent plasma: pharmaceutical characteristics and clinical experience
Giancarlo Maria Liumbruno1, Massimo Franchini
1UOC di Immunoematologia e Medicina Trasfusionale e UOC di Patologia Clinica, San Giovanni Calibita Fatebenefratelli Hospital, Rome, Italy, giancarlo@liumbruno.it.
Journal of Thrombosis and Thrombolysis
|May 22, 2014
Summary
Solvent/detergent treatment is a 30-year-old virus inactivation method for plasma products. Solvent/detergent plasma offers high decontamination and proven safety for bleeding disorders.
Area of Science:
- Biotechnology
- Hematology
- Virology
Background:
- Solvent/detergent (S/D) treatment is a well-established virus inactivation technology.
- It has been industrially applied in manufacturing plasma-derived medicinal products for nearly 30 years.
- S/D plasma is characterized by standardized clotting factor content and reduced antibodies linked to transfusion-related acute lung injury.
Purpose of the Study:
- To review the pharmaceutical characteristics of solvent/detergent plasma.
- To summarize the clinical experience and efficacy of S/D plasma in treating bleeding disorders.
Main Methods:
- This is a narrative review.
- Literature search on pharmaceutical properties and clinical studies of S/D plasma.
- Focus on safety and efficacy data.
Main Results:
- S/D plasma demonstrates a very high level of decontamination from transfusion-transmissible infectious agents.
- Numerous clinical studies confirm its safety and efficacy.
- Effective in managing both congenital and acquired bleeding disorders.
Conclusions:
- Solvent/detergent plasma is a safe and effective pharmaceutical product.
- Its established virus inactivation technology ensures high decontamination levels.
- Clinical evidence supports its use in various bleeding disorders.
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