Two specific virus clearance steps plus additional process steps
AlphaNine SD has two specific virus clearance steps (Solvent Detergent and Nanofiltration) with the capacity to act against both enveloped and non-enveloped viruses. These two steps plus additional process steps (such as dual-affinity chromatography) contribute to virus safety.
Grifols has investigated the manufacturing process or AlphaNine SD for the capacity to decrease infectivity of prions, such as the Creutzfeld-Jakob Disease (CJD) or variant CJD agents. These studies provide reasonable assurance that low levels of CJD or vCJD, if present in the starting material, would be removed.1,2
Proven safety profile
- AlphaNine SD had no confirmed seroconversions
AlphaNine SD is made from human plasma. Plasma products carry a risk of transmitting infectious agents, including viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.
Allergic type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. The administration of plasma preparations may cause allergic reactions, mild chills, nausea or stinging at the infusion site.