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NEW BRUNSWICK, NJ—On March 2, Hemispherx Biopharma, Inc. a Philadelphia-based company with a manufacturing facility located on Jersey Avenue, announced that it has finished upgrades totaling $8 million to its Hub City plant.
The upgrades to the facility will provide the capacity to supply both the U.S. and South American market, the company said.
The company said the plant will benefit from a more cost-effective manufacturing process for the production of Alferon N Injection, the only FDA-approved natural alpha interferon.
As the only natural source, multi-species alpha interferon currently approved for sale in the U.S., Alferon N is for the treatment of refractory or recurring external genital warts caused by human papilloma virus (HPV) in patients 18 or older.
A press release from the company credits "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,” reads the Hemispherx press release.
Hemispherx is a specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities known as “biological modifiers.” The company states that its technology includes components to treat seriously debilitating disorders, especially life-threatening viruses.
But, seven years ago, Hemispherx stopped manufacturing and marketing Alferon N Injection due to high labor costs associated with producing it. Moreover, low manufacturing capacity at the New Brunswick plant greatly limited the injection's commercialization potential.
Producing the Alferon in hundreds of small flasks, as required by the original production process was extremely labor-intensive, said the company.
The 43,000-square-foot Hub City facility boasts a new 600-liter bioreactor that cuts down on the previous labor-intensive method, using 100 six-liter flasks for the same size batch.
The company says that scaling up to the automated 600-liter bioreactor has eliminated 80% of the manpower previously needed for that part of the process.
Still, the company notes that the FDA will need to re-affirm the amended Biological License Application for their New Brunswick facility before the commercial sale of Alferon N Injection is permitted.
Hemispherx anticipates having product available for distribution by Armada Healthcare late this year, it says.
According to industry sources, global sales of interferon was approximately $7.8 billion in year 2013 (from multiple manufacturers). About two-thirds of the $7.8 billion was generated in the U.S.
Separately, the Food and Drug Administration last week approved the first copy of a biotechnology drug for the U.S. market.
Remicade, a drug developed by New Brunswick's own Johnson & Johnson, treats Rheumatoid arthritis and did $4.50 billion in sales last year.
Since it’s considered one of the so-called “expensive biotech drugs,” rivals including, Hospira, Pfizer, and Samsung are developing their own “biosimilar” versions.