ImClone Systems

AKP has had a long, distinguished track-record in the design, construction and validation of biotech facilities at the Bridgewater Technical Center of Pharmaceutical Excellence.

ImClone’s new monoclonal antibody (MAB) cancer therapeutic, Erbitux, targets the epidermal growth factor receptors (EGFR) on solid tumors, including colorectal, head and neck, pancreatic and lung cancers. Erbitux has received the FDA approval for advanced colorectal cancer. Additional clinical testing continues on Erbitux for other cancer treatments.

AKP has a long history with ImClone dating back almost ten years beginning with the design of laboratories and clinical manufacturing facilities. During late nineties AKP designed and built the $53 MM Erbitux Launch Manufacturing Facility. The $ 260 MM Commercial Manufacturing Facility, designed by AKP, is under construction now, slated to be completed and brought on line by 2005. (Figure 1)

ImClone’s success story began at an existing 55,000 sq. ft. industrial facility that AKP helped renovate and convert to a biotech R&D and clinical manufacturing facility. The Launch Facility was designed and constructed on a fast-track basis and at a significantly lower overall cost than the industry norm. The Launch Facility contains multiple bioreactors and purification modules with all necessary process and utility operations for a single product. The Commercial Facility includes equipment and provisions for multi-product operation on a large scale to accommodate future manufacturing of other products in development. The critical success factors for both the Launch and the Commercial Manufacturing Facilities that AKP is responsible for are:

• Early construction management involvement,
• Construction / validation driven schedule approach,
• Efficient and effective logistics planning for the tight site,
• Early alignment of local labor unions,
• Alternative building products / techniques,
• Spatial constraint studies, and
• Use of 4D scheduling techniques (field schedule tied to 3D model).
• Single point engineering and procurement responsibility.