Betaseron^® (Interferon beta-1b) is a purified, sterile, lyophilized protein product produced by recombinant DNA techniques and formulated for use by injection. Interferon beta-1b is manufactured by bacterial fermentation of a strain of Escherichia coli that bears a genetically engineered plasmid containing the gene for human interferon beta_ser17. The native gene was obtained from human fibroblasts and altered in a way that substitutes serine for the cysteine residue found at position 17. Interferon beta-1b is a highly purified protein that has 165 amino acids and an approximate molecular weight of 18,500 daltons. It does not include the carbohydrate side chains found in the natural material.

The specific activity of Betaseron is approximately 32 million international units (IU)/mg Interferon beta-1b. Each vial contains 0.3 mg of Interferon beta-1b. The unit measurement is derived by comparing the antiviral activity of the product to the World Health Organization (WHO) reference standard of recombinant human interferon beta. Dextrose and Albumin Human, USP (15 mg each/vial) are added as stabilizers. Prior to 1993, a different analytical standard was used to determine potency. It assigned 54 million IU to 0.3 mg Interferon beta-1b.

Lyophilized Betaseron is a sterile, white to off-white powder intended for subcutaneous injection after reconstitution with the diluent supplied (Sodium Chloride, 0.54% Solution).

Bookmark this page: