Solvent/detergent plasma: pharmaceutical characteristics and clinical experience

Abstract

The solvent/detergent treatment is an established virus inactivation technology that has been industrially applied for manufacturing plasma derived medicinal products for almost 30 years. Solvent/detergent plasma is a pharmaceutical product with standardised content of clotting factors, devoid of antibodies implicated in transfusion-related acute lung injury pathogenesis, and with a very high level of decontamination from transfusion-transmissible infectious agents. Many clinical studies have confirmed its safety and efficacy in the setting of congenital as well as acquired bleeding disorders. This narrative review will focus on the pharmaceutical characteristics of solvent/detergent plasma and the clinical experience with this blood product.

Dried Plasma

“…Pathogen inactivation methods used for plasma include solvent/detergent (S/D) treatment and photochemical inactivation techniques [17]. S/D treatment, which is FDA-approved, binds lipid-enveloped viruses and bacteria to inactivate them followed by a filtration process to remove cells and debris, but it has no effect against non-enveloped viruses and prions [48]. Rigorous screening standards require testing donors for non-enveloped viruses twice at a 6-month interval to decrease the risk of transmission.…”

“…Standard S/D treatment causes a decrease in vWF activity (24%), factor V (37%), protein S (44%), and alpha-2 antiplasmin (79%). Similarly, amotosalen + UV light reduces factor VII (23%) and factor VIII (27%) [17,48]. A newer S/D treatment product, Octaplas LG (Octapharma, Lachen, Switzerland), received FDA clearance in 2013 and employs a prion reduction step and a modified S/D process that better preserves factor levels [17].…”

Pathogen reduction and blood transfusion safety in Africa: strengths, limitations and challenges of implementation in low‐resource settings

“…Studies have shown that there is no significant clinical difference in between S/D plasma and standard plasma. In fact, patients receiving S/D plasma have shown a lower incidence of adverse events such as transfusion‐associated acute lung injury (TRALI) and allergic transfusion reactions . Treatment and donor pooling also provide greater standardization of coagulation factors as compared to single‐donor units of plasma .…”

Solvent/detergent-treated plasma: a tale of 30 years of experience

“…S/D-treated plasma has been developed to reduce the risks associated with the use of untreated plasma [62]. The S/D technology virtually eliminates the risk of transmission of enveloped viruses, such as HIV, HBV and HCV.…”