Human Genome Sciences Large-Scale Manufacturing (LSM)
Focused on Scientific and Operational Excellence
The 300,000-square-foot manufacturing facility houses a cell culture process train, as well as bulk fill operations that support clinical trial and large-scale production requirements. Process support functions include central weigh and dispense, media prep, buffer prep/buffer hold, and dedicated glass wash areas. Clean process utilities include fully redundant, clean steam generators, clean air and process gases, and generation and storage of water for injection.
A uniflow system of clean and return corridors was designed to comply with stringent manufacturing requirements and to minimize the risk of cross-contamination. Dedicated air-handling units provide appropriate air classifications for FDA-regulated manufacturing as well as for Biosafety Level 1 biocontainment.
Wastewater treatment is located inside the building, including continuous biowaste inactivation and process waste neutralization. The three-story facility also contains process support and warehouse areas, quality assurance/quality control laboratories, and administrative offices. An 18-MW standby emergency diesel generator and an uninterruptible power supply system ensures that power to critical systems can be maintained at all times.