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Hemispherx Completes Upgraded Alferon Facility

Integrates continuous flow manufacturing technology

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By: Kristin Brooks

Managing Editor, Contract Pharma

Hemispherx Biopharma, Inc. has completed its new manufacturing site in New Brunswick, NJ, which now encompasses more than 43,000 sq.-ft. The $8 million in upgrades provides higher capacity and a more cost effective manufacturing process for Alferon N Injection, which is the only FDA-approved natural alpha interferon.
 
The company was able to increase efficiency by integrating continuous flow manufacturing technology throughout the process, improving costs, enhancing yields, real-time process monitoring, flexibility to tailor batch size for lean manufacturing, and improved operational safety.
 
A 600-liter bioreactor was installed instead of a labor-intensive method using 100 x 6 liter flasks for the same size batch, which has eliminated ~ 80% of the manpower previously needed for this part of the process.
 
In March 2008, the company had stopped manufacturing and marketing Alferon N Injection due to high labor costs and low capacity, which limited commercialization potential.
 
The FDA will need to re-affirm the amended Biological License Application (BLA) for the facility, but the company is anticipating having commercial product available for distribution by Armada Healthcare by late 2015.

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