Human Genome Sciences Opens Manufacturing and Process Development Plant

Last month, Human Genome Sciences Inc. (HGS; Rockville, MD) opened a new 80,000 square foot, $42 million manufacturing and process development plant, believed to be the first facility in the world designed to manufacture drugs resulting from genomics R&D.

At the opening ceremony, William A. Haseltine, Chairman and CEO of HGS, said, "As the world's genomics pioneer, we were the first to achieve two important industry milestones. HGS was the first group anywhere to sequence most of the genes in the human genome. HGS also was the first company to place three genomics-derived drugs into human clinical trials. Our hope is that HGS will be the first company to manufacture and market genomics-derived drugs, and to do so within these four walls."

The principal aim of the new plant will be to supply materials for HGS's ongoing clinical trials and to assure, according to company spokeswoman Kate de Santis, that these materials are manufactured under the same stringent (cGMP) protocols as drugs destined for the marketplace. "In this regard HGS is doing exactly what any other pharmaceutical company would do at a similar stage of product development," de Santis stated.

The way the new plant was financed (see related story) will enable HGS to retain most of its cash assets for drug development. Funding was provided by First National Bank of Maryland, the State of Maryland, and Montgomery County.

HGS's new facility is the first building to be located on The Johns Hopkins University Belward Research Campus, a 138-acre tract which will be developed by The Johns Hopkins University to focus on research and development laboratories, associated office space, government agencies and healthcare delivery facilities. The site provides additional space for additional facilities which may be built at a later date. In addition, HGS has negotiated certain rights to acquire additional parcels of land on the Belward Research Campus for further development of R&D, administration, and/or manufacturing facilities.

Construction of a 40,000 square foot expansion shell for the 80,000 square foot Manufacturing and Process Development Plant is now underway. This expansion area will house another production line, using another expression system. HGS currently occupies approximately 178,000 square feet of laboratory and office space in the Shady Grove Life Sciences Center, which house approximately 400 employees.

Founded in 1992, HGS discovered the great majority of human genes and created a fully integrated, genomics-based drug discovery and development capability. Three of the genes HGS discovered are currently undergoing HGS- sponsored human clinical trials. Two of these drugs may protect sensitive tissues of the body from the damaging effects of cancer therapies. These are myeloid progenitor inhibitory factor-1 (MPIF-1), a protein that protects blood precursor cells; and keratinocyte growth factor-2, a protein that speeds the repair of damaged mucosal tissues and accelerates the healing of serious, chronic wounds to the skin. The third drug is based on vascular endothelial growth factor-2 (VEGF-2), which has the potential to revascularize the heart and limbs.

Plant Details
The new plant was built to house manufacturing and process development for the production of human gene- and protein-based drugs for use in human clinical trials and initial sales launch. It comprises 80,000 square feet of space on two levels, containing one cGMP production suite and two purification lines. The Plant's configuration allows production of multiple protein and DNA drugs and is designed to accommodate expansion. Construction of a 40,000 square foot expansion shell is now underway. This expansion area will house another production line, using another expression system.

Site Selection
HGS management sought to locate the facility close to its existing operations while controlling its cost to make the project economically feasible. Both the State of Maryland and Montgomery County provided excellent support and cooperation which assisted HGS in meeting these goals. Company management had several primary selection criteria, including:

• permits and scheduling to facilitate construction timelines
• incentives available to permit economical development of the facility
• acquisition and development cost of the site
• proximity to HGS' 400 employees in the Shady Grove Life Sciences Center
• site flexibility and constructability to support initial building and future expansion
• adequacy of utilities, including power, water and gas

More than 130 sites in five counties within three states were reviewed. HGS selected the 10-acre site on The Johns Hopkins Belward Research Campus, a 138-acre tract to be developed by The Johns Hopkins University in Montgomery County. Adjacent to the Shady Grove Life Sciences Center, the site is just minutes from HGS's 178,000 square feet of headquarters and laboratory facilities, which house approximately 400 HGS employees.

Financial Structure
The Plant was financed through a 20-year operating lease with MEDCO, the Maryland Economic Development Corp., with assistance from First National Bank of Maryland. Both the State of Maryland and Montgomery County provided excellent support and cooperation in the financing and site selection for the project.

Site Consultant, Plant Designers, Builders, Construction Management
Designed by: Fluor Daniel, a leader in the design and construction of biotechnology facilities. Shell Construction by: Manekin Corp., a leading Maryland-based real estate development and construction company. Construction Management and Fit Out by: Gilbane, a construction manager of complex biotechnology and pharmaceutical facilities. Site Consultant: Scheer Partners, a top site selection consultant.

For more information: Kate de Santis, Human Genome Sciences Inc., 9410 Key West Ave., Rockville, MD 20850-3338. Tel: 301-309-8504. Fax: 301-309-8512.