February 27, 2017
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Buminate

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Buminate 25%

CLINICAL PHARMACOLOGY

Albumin is responsible for 70-80% of the colloid osmotic pressure of normal plasma, thus making it useful in regulating the volume of circulating blood.4-6 Albumin is also a transport protein and binds naturally occurring, therapeutic and toxic materials in the circulation.5,6

BUMINATE 25% is osmotically equivalent to approximately five times its volume of human plasma. When injected intravenously, 25% albumin will draw about 3.5 times its volume of additional fluid into the circulation within 15 minutes, except when the patient is markedly dehydrated. This extra fluid reduces hemoconcentration and blood viscosity. The degree and duration of volume expansion depends upon the initial blood volume. In patients with decreased blood volume, the effect of infused albumin can persist for many hours; however, in patients with normal blood volume, the duration will be shorter.7-9

Total body albumin is estimated to be 350 g for a 70 kg man and is distributed throughout the extracellular compartments; more than 60% is located in the extravascular fluid compartment. The halflife of albumin is 15 to 20 days with a turnover of approximately 15 g per day.5

The minimum plasma albumin level necessary to prevent or reverse peripheral edema is unknown. Some investigators recommend that plasma albumin levels be maintained at approximately 2.5 g/dL. This concentration provides a plasma oncotic pressure value of 20 mm Hg.4

BUMINATE 25% is manufactured from human plasma by the modified Cohn-Oncley cold ethanol fractionation process, which includes a series of cold-ethanol precipitation, centrifugation and/or filtration steps followed by pasteurization of the final product at 60 ± 0.5°C for 10 - 11 hours. This process accomplishes both purification of albumin and reduction of viruses.

In vitro studies demonstrate that the manufacturing process for BUMINATE 25% provides for effective viral reduction. These viral reduction studies, summarized in Table 1, demonstrate viral clearance during the manufacturing process for BUMINATE 25% using human immunodeficiency virus, type 1 (HIV-1) both as a target virus and model for HIV-2 and other lipid-enveloped RNA viruses; bovine viral diarrhea virus (BVDV), a model for lipid-enveloped RNA viruses, such as hepatitis C virus (HCV); West Nile Virus (WNV), a target virus and model for other similar lipid-enveloped RNA viruses; pseudorabies virus (PRV), a model for other lipid-enveloped DNA viruses such as hepatitis B virus (HBV); mice minute virus (MMV), models for non-enveloped DNA viruses such as human parvovirus B 1910; and hepatitis A virus (HAV), a target virus and a model for other non-enveloped RNA viruses.

These studies indicate that specific steps in the manufacture of BUMINATE 25% are capable of eliminating/inactivating a wide range of relevant and model viruses. Since the mechanism of virus elimination/inactivation by fractionation and by heating steps is different, the overall manufacturing process of BUMINATE 25% is effective in reducing viral load.

Table 1: Summary of Viral Reduction Factor for Each Virus and Processing Step

Process Step Viral Reduction Factor (log10)
Lipid Enveloped Non-Enveloped
HIV-1 Flaviviridae PRV HAV Parvoviridae
BVDV WNV MMV
Processing of Fraction I+II+III/II+III supernatant to Fraction IV4 Cuno 70C filtrate* >4.9 >4.8 >5.7 >5.5 >4.5 3.0
Pasteurization >7.8 >6.5 n.d. >7.4 3.2 1.6†
Mean Cumulative Reduction Factor, log10 >12.7 >11.3 >5.7 >12.9 >7.7 4.6
*Other Albumin fractionation process steps (processing of cryo-poor plasma to Fraction I+II+III/II+III supernatant and processing of Fraction V suspension to Cuno 90LP filtrate) showed virus reduction capacity in in-vitro viral clearance studies. These process steps also contribute to the overall viral clearance effectiveness of the manufacturing process. However, since the mechanism of virus removal is similar to that of this particular process step, the viral inactivation data from other steps were not used in the calculation of the Mean Cumulative Reductio Factor.
†Recent scientific data suggests that the actual human parvovirus B19 (B19V), is far more effectively inactivated by pasteurization than indicated by model virus data.10

REFERENCES

4. Tullis JL: Albumin, 1. Background and use, and 2. Guidelines for clinical use. JAMA 237:355- 360, 460-463, 1977

5. Peters T Jr: Serum albumin, in The Plas ma Proteins , 2nd ed, Vol 1. Putnam FW (ed). New York, Academic Press, 1975, pp 133-181

6. Finlayson JS: Albumin products. Semin Thromb Hemos tas . 6:85-120, 1980

10. J. BlĂ¼mel et al., Inactivation of Parvovirus B19 During Pasteurization of Human Serum Albumin. Trans fus ion 42:1011-1018 , 2002

Last reviewed on RxList: 11/21/2016
This monograph has been modified to include the generic and brand name in many instances.

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