Merck offers first glimpse of $300m vaccine plant

For the first time Merck has opened the doors of its under-construction manufacturing plant in North Carolina to public officials, boasting it will eventually contribute about two-thirds of its annual live-virus vaccine production.

During their tour of the facility in Durham, local politicians, who have given Merck around $40m (€31m) in tax breaks and other financial incentives, were told that construction in the facility will finish next year and commercial production is expected to start in the spring of 2009, about six to nine months ahead of schedule.

The facility, the first site to make vaccines outside the company's division headquarters in West Point, Pennsylvania, will every year produce as many as 25m doses of vaccines against measles, mumps and rubella (MMR) and chickenpox. It will also manufacture Zostavax, Merck's shingles vaccine, which was approved by the US Food and Drug Administration (FDA) in May.

"The new facility has an automatic vial distribution system that can handle more than 100,000 doses of product per day in an aseptic manufacturing environment," Merck spokesman Pat Witmer told In-PharmaTechnologist.com.

"Apart from our approved products we will be also using the facility to support the manufacturing of other vaccines currently in development."

The New Jersey drugmaker, who saw its materials and production costs jump 25 per cent for the second quarter of 2006, is engaged in major restructuring and sees the Durham site as an opportunity to introduce efficiencies and cut waste, in spite of the $300m it will spend on it.

In the tour Merck was keen to show off its lyophiliser line, where glass vials that have been filled with a mixture of sterile water, live virus and other ingredients enter the line with a rubber stopper placed on top.

The vials exit sealed after two days containing a plug of freeze-dried vaccine that has to be refrigerated.

Despite no other drugmaker moving frozen vials, Merck plans to move shelves containing up to 116,000 vials of frozen vaccine on robots that travel on a rail, so engineers have calculated they would have about 30 minutes to fix a breakdown before vaccine starts to thaw.

The equipment is already installed and testing has begun, with as many as 200 workers expected to come in when the plant becomes fully operational in 2008.

Long term up to 600 people could be employed at the location and the average annual salary there will be $56,000.

The site features three buildings and an energy centre which will supply the facility with steam, chilled water, cooling liquid and conditioned air.

Merck's 250,000-square-foot facility in Durham will add to a long list of manufacturing plants in North Carolina, which, with the help of state government, has become a hub for biopharmaceuticals, ranking third in the US in number of biotechnology companies for the third consecutive year, according to Ernst & Young's 2006 industry survey.

GlaxoSmithKline has a number of nearby facilities and other biopharma operations are in the Research Triangle Park and other locations in the Raleigh/Durham area.

Last month Novartis decided it will invest up to $600m to build a vaccine manufacturing plant in Holly Springs, southwest of Raleigh, with the ambition to produce 50m doses of seasonal trivalent flu vaccines annually.