03.02.15
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.
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.