Emergent boosts Baltimore bio capacity, plans Lancing expansion
The US drugmaker said the 55,000 sqft expansion “will allow for the utilization of disposable manufacturing technology to potentially result in lower capital investments, lower operating costs, and accelerated process development timelines.”
At present the facility, which was acquired late last year, produces Emergent’s anthrax monoclonal antibody, BioThrax, the only one approved by the US Food and Drug Administration. However, according to media reports, the firm plans to use the extra capacity to expand its business.
Company director of manufacturing operations told the Washington Post that while the new plant secures Emergent’s position in the anthrax market, it will also enables the firm “to move outside the biodefense realm and into more commercial segments."
And, while details of these “commercial segments” were not disclosed, the paper reported that construction plans indicate that the five existing laboratories at the plant will be combined into two separate units for vial and non-viral vaccines.
This capability would fit with the firm’s product pipeline, which already includes vaccines for the treatment of tuberculosis, typhoid, chlamydia and a universal influenza treatment.
$107m BioThrax contract
However, while the new Baltimore capacity is an indication of Emergent’s business development plans, BioThrax maintains its position at the heart of the firm’s portfolio as a result of a recent $107m (€83m) manufacturing contract.
The deal, announced to coincide with the opening ceremony at Baltimore, will see Emergent increase BioThrax manufacturing capacity at its plant in Lancing, Michigan to 26m doses.
At present the facility produces a maximum of 8m doses a year, meaning that it will require substantial refurbishment and expansion.
Emergent has outlined plans to demonstrate comparability between the current manufacturing process and the large-scale manufacturing process for BioThrax, and will use part of the funding for process validation, fill/finish and additional studies if required.
The contract was awarded by the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS) as part of an effort to build up its strategic national stockpile.
Commenting on the new contract Emergent CEO Fuad El-Hibri said: "We applaud HHS for its unwavering commitment to strengthen the country's biodefense infrastructure and to protect our military and civilian populations."
Emergent anticipates the production of consistency lots by the end of 2011.
