Hemisphere Biopharma Completes Mfg Expansion

The specialty pharmaceutical company, Hemispherx Biopharma, Inc.,has completed $8 million of upgrades at its manufacturing site  in New Brunswick, New Jersey. These upgrades will provide for higher capacity and a more cost-effective manufacturing process for the production of Alferon N Injection, an FDA-approved natural alpha interferon.

The upgraded facility is installed with a 600-liter bioreactor, In March 2008, the company halted the manufacturing and marketing of Alferon N Injection due to the high labor cost for manufacturing Alferon and low capacity. The original manufacturing process produced Alferon in hundreds of small flasks and was labor-intensive. The upgraded manufacturing facility, which uses a 600-liter bioreactor, will provide a more cost-effective process and provide capacity to supply both the US and South American markets. The company also integrated continuous flow manufacturing technology into the production process.

The US Food and Drug Administration will need to re-affirm the amended biological license application (BLA) for the facility before the commercial sales of Alferon N Injection are re-commenced. The company is anticipating having commercial product available for distribution by Armada Healthcare by late 2015.

Alferon N is approved in the US for the treatment of refractory or recurring external genital warts caused by human papilloma virus in patients 18 years of age or older.

Source: Hemisphre Biopharma

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