The manufacturing process for ALPHANATE demonstrates the capacity to eliminate and inactivate a wide panel of viruses
Total virus-reduction capacity for combined elimination steps1
ALPHANATE has FDA-approved labeling for prion removal
The manufacturing process of ALPHANATE has the capacity to decrease the infectivity of models for the variant Creutzfeldt-Jakob disease (vCJD) and CJD agents if they were present in source material.
Because ALPHANATE is made from human plasma, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.
The manufacturing process for ALPHANATE was investigated for its capacity to decrease infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the CJD and vCJD agents. TSE reduction steps include: 3.5% polyethylene glycol precipitation, affinity chromatography, and saline precipitation. These studies provide reasonable assurance that low levels of vCJD and CJD agent infectivity, if present in the starting material, would be removed.
|Western blot* reduction capacity (log10)||Bioassay reduction capacity (log10)|
|Western blot* reduction capacity (log10)||3.32|
|Bioassay reduction capacity (log10)||3.23|
|Western blot* reduction capacity (log10)||≥3.46|
|Bioassay reduction capacity (log10)||3.50|
|Western blot* reduction capacity (log10)||2.28|
|Bioassay reduction capacity (log10)||1.36|
*Western blot assay: representative (average) reduction factor and clearance factor for 2 types of PrPSc spikes: membrane-associated fraction and detergent-solubilized fraction. †Saline precipitation: calculated using clearance factor.
FVIII, factor VIII; VWF, von Willebrand factor.