Integration of 34,000sf of manufacturing space within 3 floors of a high-rise corporate office building with 12’ 3” foot floor-to-floor, adjacent to the bulk manufacturing operations of small and large molecule APIs. The completed facility provided new flexibility, capability and capacity, which mitigated risk of supply chain interruption, complemented existing bulk API manufacturing assets and met strategic drug development/manufacturing needs for the next 20 years.

The barrier isolator vial and BFS production lines were specifically configured to support the manufacturing needs of the company's orphan drug products. Capacity was significantly expanded over what is stated by re-configuration and/or staff expansion.

• Within 20 months, facility was validated and 2 products were qualified on 2 different lines and granted full commercial approval
• Building was awarded USGBC LEED Gold in April 2010 and USGBC’s Project of the Year in June 2010
• Urban, business district location with space limitations required an innovative design
• Outstanding facility integration of flexible, multi-purpose aseptic fill/finish manufacturing operations into a non-negotiable footprint without compromise to CGMP or building architecture
• Complements existing site capabilities for bulk manufacture of small and large molecule APIs
• State-of-the-art aseptic fill/finish manufacturing space located on 3 floors of unique “round”, 7-story headquarters
• Fourth floor mechanical space features a walkable ceiling for isolator air handlers and support equipment
• Integration of process development laboratory space
• Combined liquid and lyophilized product filling capability into a single line addressing process stream and R&D gaps; formulation to packaging within one facility for multiple sterile injectable dosage forms, ultimately saving approximately $9MM
• Selection and integration of advanced aseptic technologies lowered quality risk and overall cost containment
• Multi-purpose laboratory where cell culture and purification research can be performed on future immunotherapeutic monoclonal antibodies
• Capability and capacity to manufacture both sterile liquid and sterile lyophilized products
• Total single-use (SU) disposable technology on the barrier isolator vial line eliminated CIP/SIP systems and offered multiple benefits
• Continuous batch processing saved $4MM by eliminating transfer isolators
• Increased capacity and flexibility of manufacturing capabilities and enhanced control of supply chain
• Facility and site integration with the community of Silver Spring, Maryland
• Significant sustainable and energy operating cost savings through innovative design and project teaming
• Efficient and innovative design required for equipment layout due to space constraints
• For several equipment vendors, this project offered many unique, first-time configurations
• Extensive sustainable design and energy cost savings and analysis implemented throughout manufacturing operations