Hemispherx upgrades New Jersey Alferon plant months after drug shows anti-Ebola efficacy

By Gareth Macdonald

- Last updated on GMT

Hemispherx completes New Brunswick site expansion
Hemispherx completes New Brunswick site expansion

Related tags Food and drug administration

Hemispherx has installed a 600 litre bioreactor at its manufacturing facility in New Jersey and plans to seek approval to restart production of its alpha interferon product, Alferon N Injection.

Alferon was approved by the US FDA in 1989 for the treatment of certain types of genital warts, specifically those linked to cervical cancer.  

However, the drug has not been on the market since 2008 after Hemispherx halted production when the cost of making it proved to be too high.

At the time the firm said labour expenses coupled with limited manufacturing capacity drove the decision.

Upgrade

Hemispherx spent $8m (€7.1m) upgrading the New Brunswick facility, replacing the six 100 litre reactors with a single 600 litre unit. The firm said the investment allowed to cut the manpower needed to make the drug by 80%.

It also said the new tech “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​.”  

Hemispherx plans to ask the US Food and Drug Administration (FDA) to re-affirm the amended Biologics Application (BLA) for the upgraded plant.

If approved by the agency Hemispherex said it plans to sell Alferon in the US and South American markets in partnership with distributor Armada Healthcare.

Ebola

News of the expansion comes a few months after Hemispherx started testing Alferon and its other product Ampligen – a double stranded RNA therapeutic – against the Ebola virus in collaboration with the US military.

On Novermber 3 the firm announced that tests by USAMRIID scientists show that Alferon "successfully protected human cells against the Ebola virus​."

"The overall effect is to establish a framework for clinical interventions in both preventative and therapeutic settings of Ebola virus disease (EVD) by rational combinations of the two experimental products to treat Ebola​" it said.

Last month​ the firm announced that, in animal studies, mice treated with Ampligen survived Ebola infection.

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