Medimmune, Biologics Manufacturing Facility Frederick, Maryland, USA

In September 2006 MedImmune Inc, a Maryland-based biologics company working in the areas of infectious diseases, cancer and inflammatory diseases, started the construction of a new phase of its biologics manufacturing facility at the company's Frederick site, Maryland, US. MedImmune has been established in Maryland for 18 years and is best known for its production of FluMist, a nasal-spray flu vaccine (manufactured in Philadelphia).

The $250m expansion is the first phase of a multi-phase construction project that was first announced in October 2005. The new facility will have a manufacturing floor space of 710,000ft² (first phase 331,000ft²) and will allow the addition of up to 225 employees to the site's workforce by 2009. More than 600 extra employees will be added to the Gaithersburg HQ and R&D site, where further expansion is underway.

The expansion will increase the company's cell culture manufacturing production capacity, in preparation for production of monoclonal antibodies that are currently in development, should they receive final approval by the FDA.

The facility will be built adjacent to a 150,000ft² site in Frederick that was built in the mid-1990s and is used to produce Synagis, a treatment that prevents some respiratory infections in babies. The company already owned an additional 35 acres of land surrounding the Frederick facility and part of this will be used for expansion. The new plant will include two additional commercial-scale bioreactors to produce monoclonal antibodies.

RECENT CONTRACTS

In the third quarter of 2006 MedImmune was given a $170m, five-year contract from the US Department of Health and Human Services (HHS) to develop cell culture-based seasonal and pandemic vaccines. The Frederick, Maryland, facility will be the future production site for the new vaccines. The contract is part of the US government's goal to provide enough capacity to protect every American citizen on a year-round basis.

CONSTRUCTION

MedImmune has purchased the raw materials and equipment, such as structural steel and bioreactors, needed for the expanded facility. The company has also designated Parsons as the architectural firm responsible for the design of the new facility. Phase 1 of the expansion is expected to be complete in late 2009. MedImmune, the City of Frederick Department of Economic Development, and the Frederick County Office of Economic Development are collaborating on the infrastructure necessary to support the site expansion.

The State of Maryland transportation department has said it will spend more than $100m on road improvements in the area. The City of Frederick and the State of Maryland fought to keep the company from building in another state. The financial incentives put together to keep MedImmune were worth an estimated $19.5m. Aris Melissaratos, Maryland Secretary of business and economic development said: "Had we not gotten it (MedImmune) to expand here, it would've been an embarrassment… MedImmune has always been our poster child for how to grow a biotech company and a biotech industry."

David M Mott, Chief Executive of MedImmune, said: "The company spent a year investigating possible sites for the facility, both inside and outside the US. The financial package presented by the state, city and Frederick County played a significant role in the decision to stay in Frederick, as did the relationship it (MedImmune) has with the local government and biotechnology community. The incentives included $3.75m in business and property tax forgiveness and $1.2m for workforce training."

The company's plan is to turn the Frederick site into its primary manufacturing facility, while the Gaithersburg building will continue to house its research and development operations and corporate offices. There are already 1,000 employees in Maryland between the two sites (225 workers in Frederick and 775 workers in Gaithersburg).

NEW COMPOUNDS

MedImmune already produces Synagis (palivizumab), the first monoclonal antibody approved by the FDA to help prevent an infectious disease, at the Frederick site. The company has about 30 drug candidates in development at the current time including potential treatments for lupus and some types of cancer.

ORIGINAL PLANT

The Fredrick site was developed in 1996. The manufacturing facility required an investment of $30m to construct and the state and city provided a $13m incentive package.

The company originally purchased a 26 acre area of land in the Center Park business park, which included 15 acres for the 90,500ft² plant (expanded in 2001 to the current 150,000ft²) and 11 acres that the company intended to use for a new corporate headquarters, should it decide to move from Gaithersburg (ultimately the HQ was not moved and additional land was purchased for expansion).

The plant was completed by 1998 and in full production in 1999, producing an infant pneumonia drug called RespiGam. The general contractor was Riparius Construction, Inc; the construction manager was Fluor Daniels, and the architect/designer was also Fluor Daniels. Tri-State Drywall was also involved in the construction. The project consisted of experimental laboratories, Class 10M–100M cleanroom spaces, bio-secure manufacturing facilities and support office space.

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