GSK opens US hub for vaccine manufacturing

pharmafile | January 14, 2009 | News story | Manufacturing and Production GSK 

GlaxoSmithKline has officially unveiled a $300 million manufacturing plant in Pennsylvania that will serve as the cornerstone of its US vaccines business.

GSK will initially use the Marietta plant for finishing of its already-marketed Engerix-B vaccine for hepatitis B and plans to start shipping product in April, subject to regulatory approval.

The US facility will assemble, label and pack syringes containing the vaccine, using bulk material produced at the company's vaccine headquarters in Rixensart, Belgium.

GSK bought the 90-acre Marietta site from Wyeth in 2005, saying that it would be used to develop and generate "the next generation of vaccines", including influenza shots produced using tissue culture technology.

At the time GSK paid just $14m for the plant, which was being wound down by its former owner. Wyeth had earmarked the facility as the production unit for Flumist, an inhaled flu vaccine partnered with MedImmune, but the product failed to take off as predicted.

GSK is ranked number two in the vaccine market after Merck and produces 30 vaccines. In the first nine months of last year these accrued total revenues of £1.7 billion, a rise of 18% over the same period in 2007.

The drugmaker currently has a healthy pipeline of new vaccines heading for the US market.

It recently launched two new vaccines there – Rotarix for rotavirus and the combination diphtheria, tetanus, pertussis and polio vaccine Kinrix (DTaP-IPV).

The firm is also awaiting US approval of two others, namely its fast-growing Cervarix product which protects against cervical cancer and PrePandrix, a 'pre-pandemic' flu vaccine.

In time the new plant will handle all GSK's US vaccines packaging and distribution operations. The plant is expected to be fully operational in 2013 with a workforce of around 250 employees. At that time it will not only carry out finishing and distribution of vaccines, but also aseptic production of viral antigens, vaccine formulation and freeze drying activities.

The opening of the Marietta facility provides a compelling reminder of the renaissance of vaccines as a core business for the pharmaceutical industry.

10 years ago vaccine research was a backwater in pharmaceutical R&D, but vaccines are now outstripping the growth of other drug classes.

Already valued at more than $21bn, the global vaccine business is tipped to grow 18% a year to reach $30bn in 2011, according to data from Lehman Brothers. During the same period the drug industry as a whole is expected to experience growth of around 5%.

Meanwhile, Merck said last week that upgrades at its manufacturing facility in West Point, Philadelphia, had interrupted supplies of its hepatitis B vaccine Recombivax HB for adults.

Paediatric doses would not be affected, said Merck, and added that the upgrades were not related to warnings it received in April 2008 about adherence to quality standards.

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