Nabi opens vaccine production facility
vaccine manufacturing facility in Boca Raton, Florida.
The company completed construction of the facility, which will be used to produce commercial quantities of StaphVAX (Staphylococcus aureus polysaccharide conjugate vaccine) in just eight months.
StaphVAX is currently in Phase III development to prevent S aureus infections in end-stage renal (kidney) disease (ESRD) patients, and Nabi said the new facility should be able to meet global demand for the product for the foreseeable future.
The production facility, which measures approximately 12,000 square feet, will initially be used to support the US launch of StaphVAX, but has been designed to be fully scalable. This means it will be able to supply not only StaphVAX, but also Nabi's other pipeline products, including NicVAX, a vaccine being developed to prevent and treat nicotine addiction, as well as its next generation of Gram-positive pipeline vaccine products.
The facility will be dedicated to the late Walter Karakawa, a pioneer in immunology and biochemistry, who discovered that S aureus bacteria are covered by complex sugar molecules. This finding was critical to understanding the make-up and "typing" of S aureus, which led to the genesis and later development of StaphVAX.
Nabi has adopted a dual sourcing strategy for StaphVAX to make sure its market entry goes smoothly. In addition to the Florida facility, the firm has partnered with Cambrex Bio Science in Baltimore, which is already manufacturing commercial quantities of StaphVAX in preparation for launch of the product.
"We believe that in today's vaccine manufacturing environment, a dual sourcing strategy is a prudent and necessary approach," said Fahim.
This year, in the US alone, 12 million patients will be at risk of contracting a life-threatening staphylococcal infection.
The company filed a Marketing Authorisation Application in Europe for StaphVAX in December 2004. The application was accepted for review in January 2005. In the US, StaphVAX is currently in a confirmatory Phase III clinical trial.
