The approval will enable the site to produce bulk varicella supply for the U.S. and help boost Merck’s overall global supply capabilities.
Prior to this licensure, all global bulk supplies for Merck’s varicella-containing vaccines were produced at a site in West Point, Pennsylvania.
The Durham facility is part of Merck’s more than $1 billion investment in its vaccine manufacturing capabilities over the past nine years. The company has also modernized and expanded vaccine operations at its facilities in West Point, and Elkton, Virginia, and built a new facility in Carlow, Ireland, which is scheduled to be licensed in 2014.
The company broke ground for the Durham site in 2004 and in 2010 it was approved to produce finished chickenpox vaccines. In the longer term, Merck plans for the site to produce bulk and finished product for other Merck childhood vaccines, and for the shingles vaccines as well.
“The licensure of the Durham varicella bulk facility marks a significant milestone for Merck and adds additional manufacturing capabilities to an already strong Merck vaccine network,” said Willie Deese, president, Merck Manufacturing Division. “The Durham facility will help us meet the increasing global demand for our quality vaccines that enhance health care for millions around the world.”
In 2008, Merck dedicated the facility in the memory of its most distinguished vaccine researcher, the late Maurice R. Hilleman, who developed vaccines for eight of the diseases for which vaccines are routinely recommended for children in the US. The manufacturing center in Durham employs 1,100 people.