Advanced Aseptic Fill / Finish Facility
State-of-the-art advanced aseptic fill / finish facility, complementing existing site capabilities for bulk manufacture of small and large molecule APIs and providing a flexible, multi-purpose, sterile manufacturing operation. With a commitment to risk mitigation and product quality, the facility integrates two advanced aseptic technologies, Barrier Isolation and Blow-Fill-Seal, within a 70,500sf “round” 7-story office building with a non-negotiable footprint.
- Integration of 34,000sf of manufacturing space within 3-floors of a high-rise corporate office building with 12’ 3” foot floor to floor
- Provides flexibility, capability and capacity mitigating risk of supply chain interruption, complement existing Bulk API manufacturing assets and meet strategic drug development/manufacturing needs for the next 20 years
- Barrier Isolator vial and BFS production lines have been specifically configured to support the manufacturing needs of the company's orphan drug products. Capacity can be significantly expanded by re-configuration and/or staff expansion
- 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
- 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
- Multi-purpose laboratory where cell culture and purification research can be performed
- 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 offers multiple benefits
- Extensive sustainable design and energy cost savings and analysis implemented throughout manufacturing operations
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