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Buminate 5% (Albumin) - Description and Clinical Pharmacology

 
 



DESCRIPTION

BUMINATE 5%, Albumin (Human), 5% Solution, is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 mL contains 5 g of albumin and was prepared from human venous plasma using the Cohn cold ethanol fractionation process. Source material for fractionation may be obtained from another U.S. licensed manufacturer. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and has been stabilized with sodium acetyltryptophanate and sodium caprylate. The sodium content is 145 ± 15 mEq/L. The solution contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. BUMINATE 5%, Albumin (Human), 5% Solution, is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color.

The likelihood of the presence of viable hepatitis viruses has been reduced by heating the product for 10 hours at 60°C. This procedure has been shown to be an effective method of inactivating hepatitis virus in albumin solutions even when those solutions were prepared from plasma known to be infective.1-3

BUMINATE 5%, Albumin (Human), 5% Solution, contains no blood group isoagglutinins thereby permitting its administration without regard to the recipient's blood group.

CLINICAL PHARMACOLOGY

Albumin is responsible for 70-80% of the colloid osmotic pressure of normal plasma, thus making it useful in regulating and increasing blood volume.4,5,6 It is also a transport protein and binds naturally occurring, therapeutic and toxic materials in the circulation.5,6 BUMINATE 5%, Albumin (Human), 5% Solution, is osmotically equivalent to an equal volume of normal human plasma and will increase circulating plasma volume by an amount approximately equal to the volume infused. The degree and duration of volume expansion depends upon the initial blood volume. With patients treated for diminished blood volume, the effect of infused albumin may last for many hours. In patients with normal blood volumes, the hemodilution lasts for a shorter period.7,8

Total body albumin is estimated to be 350 g for a 70 kg man and is distributed throughout the extracellular compartments. The half-life 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 5%, Albumin (Human), 5% Solution, is manufactured by the modified Cohn-Oncley cold ethanol fractionation process which includes a series of cold-ethanol precipitation, centrifugation and/or filtration of human plasma followed by pasteurization of the final product at 60 ± 0.5°C for 10-11 hours. This process accomplishes both purification of albumin and the reduction of viruses.

In vitro studies demonstrate that the manufacturing process for BUMINATE 5%, Albumin (Human), 5% Solution, provides for significant viral reduction. These viral reduction studies, summarized in Table 1, demonstrate viral clearance during the manufacturing process for BUMINATE 5%, Albumin (Human), 5% Solution, using human immunodeficiency virus, type 1 (HIV-1) both as a relevant and model virus for HIV-2 and other enveloped RNA viruses; bovine viral diarrheal virus (BVD), a model for lipid enveloped RNA viruses, such as hepatitis C virus (HCV); porcine parvovirus (PPV), a model for non-lipid enveloped DNA viruses such as human parvovirus B19; hepatitis A virus (HAV), a relevant virus and a model for non-lipid enveloped RNA viruses.

These studies indicate that specific manufacturing steps for BUMINATE 5%, Albumin (Human), 5% Solution, are capable of eliminating/inactivating a wide range of relevant and model viruses. Since the mechanism of virus elimination/inactivation at each step is different, the overall manufacturing process of BUMINATE 5%, Albumin (Human), 5% Solution, is robust 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-lipid Enveloped
BVD HIV-1 PRV HAV PPV
Step 1: Processing of cryo-poor plasma to Fraction I+II+III centrifugate 1.2±0.0 5.8±0.0 4.6±0.05 1.9±0.8 1.4±0.1
Step 2: Processing of Fraction I+II+III centrifugate to Fraction IV1 centrifugate 2.8±0.5 NCM 3.4±0.4 1.9±0.7 (1.2±0.3) *
Step 3: Processing of Fraction IV1 centrifugate to Fraction IV4 centrifugate/filter press filtrate **/* >2.4±0.1/
>2.4±0.1
>/=4.4±0.5/
>/=4.5±0.5
>4.8±0.1/
>4.8±0.1
3.8±0.1/
2.9±0.2
2.2±0.3/
2.0±0.3
Step 4: Processing of Fraction IV4 centrifugate/filter press filtrate to Fraction IV4 Cuno 70C filtrate # >1.6±0.2/
>1.7±0.1
NCM >4.1±0.5/
>4.4±0.1
4.7±0.1/
4.6±0.1
2.3±0.3/
3.0±0.8
Step 5: Processing of Fraction V suspension to Cuno 90LP filtrate (0.2±0.2) * >/=5.0±0.5 >4.6±0.0 4.2±0.4 3.4±0.5
Step 6: Pasteurization >4.9±0.1 >5.1±0.3 >5.3±0.1 5.3±0.4 NT
Cumulative Reduction Factor **, log10 >12.9/13.0 >20.3/20.4 >26.8/27.1 21.8/20.8 9.3/9.8
NTNot tested.
NCMNo virus reduction claim made at this step.
*Since the reduction factor of =1.0 is within the variability limit of the assay, these values are not included in the computation of the cumulative reduction factor.
**/* Two reduction factors indicate the two liquid-solid separation options available at this step.
# Two reduction factors indicate the two starting materials at this step.
**Two cumulative reduction factors derived from the use of the two liquid-solid separation options available at Step 3.

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