Hemispherx Biopharma, Inc. announced today that its manufacturing site located in New Brunswick, New Jersey, presently configured at over 43,000 square feet, has completed its $8 million of upgrades. These upgrades will provide for a higher capacity, more cost effective manufacturing process for the production of Alferon N Injection®, the only FDA-approved natural alpha interferon. The added efficiency of the process has been accomplished by integrating continuous flow manufacturing technology throughout the process. This has led to improved cost efficiency, enhanced yields, real-time process monitoring, flexibility to tailor batch size for lean manufacturing, and improved operational safety as seen in other cutting edge pharmaceutical companies.
The upgraded facility is installed with a 600- liter bioreactor instead of a labor intensivelabor-intensive method using 100 x 6 liter flasks for the same size batch. Scaling up to the automated 600- liter bioreactor has eliminated ~ 80% of the manpower previously needed for this part of the process.
In March 2008, the company halted the manufacturing and marketing of Alferon N Injection® due to the high labor cost for manufacturing Alferon® and the low capacity significantly limiting the commercialization potential of Alferon N Injection®. The original process, producing the Alferon® in hundreds of small flasks, was extremely labor intensive. The upgraded manufacturing facility which uses a 600-liter bioreactor will provide a cost effective process and provide the capacity to supply both the US and South American market. The FDA will need to re-affirm the amended Biological License Application (BLA) for the facility before the commercial sales of Alferon N Injection® are recommenced. The company is anticipating having commercial product available for distribution by Armada Healthcare by late 2015.
According to industry sources, global sales of interferon (from multiple manufacturers) was approximately $7.8 billion in year 2013, with about two-thirds of global sales generated in the US. A review summarized and analyzed the clinical outcomes following treatment of a wide range of diseases with recombinant interferons (r-IFNs) and/or natural interferons (n-IFNs) (Strayer, et al. Recombinant and Natural Human Interferons: Analysis of the Incidence and Clinical Impact of Neutralizing Antibodies. J Interferon Cytokine Res 2012;32(3):95-102).