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Interferon As Biologics

Interferons are a group of regulatory molecules called cytokines. Infergen is an engineered interferon that was approved for treating hepatitis C. It was designed based on the most common amino acid sequences found in natural interferons. A DNA sequence coding for Infergen was inserted into E. coli, which accumulated it as inclusion bodies. The inclusion bodies are harvested, solubilized, and the interferon is purified through chromatography. The final product is a 30mg/ml solution with a 24 month shelf life when stored at 2-8°C. When compared to natural interferons, Infergen displays higher antiviral, antiproliferative and cytokine-inducing activity on a mass basis.

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0% found this document useful (0 votes)
51 views1 page

Interferon As Biologics

Interferons are a group of regulatory molecules called cytokines. Infergen is an engineered interferon that was approved for treating hepatitis C. It was designed based on the most common amino acid sequences found in natural interferons. A DNA sequence coding for Infergen was inserted into E. coli, which accumulated it as inclusion bodies. The inclusion bodies are harvested, solubilized, and the interferon is purified through chromatography. The final product is a 30mg/ml solution with a 24 month shelf life when stored at 2-8°C. When compared to natural interferons, Infergen displays higher antiviral, antiproliferative and cytokine-inducing activity on a mass basis.

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Interferons

Cytokine group of regulatory molecules

Infergen (interferon acon-1, or consensus interferon)


is an engineered IFN recently approved for the treatment of hepatitis C.

The product’s amino acid sequence reflects the most frequently occurring amino acid residue
in each corresponding position of these native IFNs.

A DNA sequence coding for the product was synthesized and inserted into E. coli.

The recombinant product accumulates intracellularly as inclusion bodies.


Large-scale manufacture entails an initial fermentation step.

After harvest, the E. coli cells are homogenized and the inclusion bodies recovered via centrifugation.

After solubilization and refolding, the interferon is purified to homogeneity by a combination of


chromatographic steps.

The final product is formulated in the presence of a phosphate buffer and sodium chloride.

30mg/ml solution in glass vials displays a shelf-life of 24 months when stored at 2-88C.

When compared on a mass basis, the synthetic interferon displays higher antiviral, antiproliferative and
cytokine-inducing activity than do native type I interferons.

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