Clinical Supplies Manufacturing and Drug Product Technology Expansion
The finished facility is a 132,300sf, state-of-the-art clinical manufacturing area with the capability to scale-up and deliver a variety of oral solid and liquid dosage forms, including sterile and high potency products.
- First GMP Operational Clinical Sterile Continuous Process Isolation Facility in the United States
- Innovative Integration of Overall Manufacturing Strategy with Scalable Design for Sterile and Oral Solid Dosage Products
- Incorporates Innovative Technologies into Existing Facility for Solvent-Based and Potent Compounds to Promote Safety, Quality and Compliance
- Wireless Technology and Electronic Batch Records Allow Development Data to be Automatically Gathered During GMP Manufacture
- cGMP Flammable Liquid Handling of Solvents
- Increased GMP Development Capabilities Allow Quality by Design Throughout the Clinical Program
- Increases Overall Capacity and Productivity for the Pipeline
- Simultaneous Multi-Product Processing
- Facilitates Technology Transfer to Commercial Sites
- Accommodates New FDA Vision for Quality by Design (QbD) and Process Analytical Technology (PAT)
- Cutting Edge, Wireless Delta V Data Gathering
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