Plasmanate®
Plasma Protein Fraction (Human) 5%, USP
Plasmanate® is a 5% protein solution comprised of approximately 88% normal human albumin, 12% alpha and beta globulins, and not more than 1% gamma globulin as determined by electrophoresis. The primary use of Plasmanate® is for replacement of lost fluids (primarily plasma), as is often required in severely burned patients.
In order to provide additional assurance regarding the virus safety of Plasmanate®, a program has been developed to investigate the relevant steps of the Plasmanate® manufacturing process for effectiveness of viral reduction. Virus validation and robustness studies have demonstrated that three steps in the Plasmanate® manufacturing process contribute to effective and robust virus removal and inactivation:1
| |
1. |
|
Removal by ethanol precipitation
|
| |
2. |
|
Inactivation by ethanol/acetone treatment
|
| |
3. |
|
Inactivation by pasteurization
|
With regard to the theoretical risk of transmission of transmissible spongiform encephalopathies (TSE) through the use of Plasmanate®, a Talecris Biotherapeutics patented Western blot assay has confirmed removal of prion protein during spiked manufacturing simulations for two of the Plasmanate® production steps2,3.
For complete prescribing information, click here.
|