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The upgrades will offer the opportunity for higher product yields and higher purity levels.
Hemispherx Biopharma announced in March 2, 2015 that the company is upgrading its New Brunswick, NJ, facility to incorporate new continuous manufacturing capabilities. The company, which produces a natural alpha interferon (interferon alfa-n3, trade name Alferon N) for the treatment of refractory or recurring external genital warts, halted the manufacture of its drug in 2008 because of high labor costs and low capacity, which the company said in a release significantly limited the commercialization potential of the treatment.
After $8 million in facility upgrades, the company integrated continuous manufacturing throughout the process. The company scaled up from hundreds of small flasks to a 600-L bioreactor, effectively eliminating approximately 80% of the manpower previously needed for this part of the process. The change also led to “improved cost efficiency, enhanced yields, real-time process monitoring, flexibility to tailor batch size for lean manufacturing, and improved operational safety,” according to the statement.
While the process improvement may improve cost efficiency, the company said that FDA will need to reaffirm the amended biologic license application for the facility before the sales of Alferon N can commence through its distributor, Armada Health Care.
Source: Hemispherx Biopharma