rHu IFN beta 1a

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Recombinant Human Inteferon beta 1A

Concentrated Solution

Formulation: rHu IFN beta 1a, 10 mM Sodium Acetate, pH 3.2 - 3.8.

Purity and Identification: SDS PAGE (reducing): Not more than two bands greater than 1% but neither of them more than 5% with molecular masses lower than the principal band.

SDS PAGE (non-reducing): one band not more than 3% in the oligomeric region

Isoelectric focusing: pI between 6.5-9.1

HPLC: principal peak >95%, no other peak>3%

Western blot identification by specific antibodies.

Sterility Test: USP XXVIII

Safety Test: USP XXVIII

Endotoxin level: less than 0.7 EU in the volume that contains 1x106 IU of interferon beta 1a. (LAL Test).

Biological Activity: Determined according to a cytopathic effect inhibition assay with VERO cells infected with vesicular stomatitis virus. (Rubinstein S, et al J.Virol.(1981) 37: 755-758, and Pestka S ed. Methods in Enzymology, Vol 78, Academic Press New York, 387-394)

Specific activity: Not less than 150 MIU per mg of protein, according to lot #.

Molecular Mass: between 20,000 and 25,000 Da

Source: CHO Cells

For research use only. Not for use in diagnostics or therapeutic procedures