Facility

The facility design provides specific zones or defined areas for each type of activity with appropriate attributes to support and segregate the different manufacturing processes. The clinical manufacturing facility is access controlled and is isolated from other operations within the center.

In July 1999, the Waisman Center presented the design and process flows to the US FDA's Center for Biologics Evaluation and Research (CBER). WCBF staff are confident that the facility's design can meet or exceed FDA guidelines for clinical research purposes.

Overview of Manufacturing Suites

Learn more about our manufacturing suites by visiting the links below. First review our facility schematic (Design Schematic Highlighting Production and Support Areas), then click on the suite you wish to view to see photos and design capabilities.

• Microbial Products Suites
• Cell Processing Suites
• Mammalian Products Suites
• Aseptic Fill Suite
• Quality Control Lab
• Cell Bank
• Raw Materials Holding & Product Quarantine
• Sterile Equipment Prep/Waste Decontamination

Capabilities

The WCBF has four general manufacturing areas for operation for clinical production. WCBF underwent extensive design planning to provide flexible capability to manufacture a variety of biologic products.

The four general processes undertaken by the WCBF are as follows:

• Production of microbial-derived biologics via fermentation (e.g. plasmid DNA, proteins)
• Production of mammalian cell-derived biologics (e.g. antibodies, proteins, viral vectors)
• Production of cell therapeutics from autologous, allogeneic or other cell sources
• Aseptic filling of bulk biopharmaceuticals for Phase I and II clinical trials

Summary of cGMP Capabilities

The facility design provides specific zones or defined areas for each type of activity with appropriate attributes to support and segregate the different manufacturing processes.

• Direct Digital Control of room pressures, air flow, temperature, and humidity by MetaSys (Johnson Controls, Inc.) with separate Air Handling Units (AHUs) for manufacturing areas
• Equipment Monitoring System (Rees Scientific) monitors critical parameters and alarms for all cGMP equipment
• Key card access control to facility, cleanroom manufacturing areas, Cell Bank, and Raw Material Quarantine/Release
• Approximately 6,000 square feet of cleanroom space for plasmid DNA/microbial proteins, cell therapeutics, viral vectors/mammalian proteins, and aseptic fill
• Aseptic fill suite with downstream labeling and inspection and Product Quarantine
• Multiple pass-throughs for flexible production of cell therapeutics or complex biologics
• Dedicated showers and gowning areas for Microbial Products and Mammalian Products/Cell Processing area
• Pure steam generator for steam-in-place (SIP) bioreactors
• Dedicated cGMP sterilization and decontamination autoclaves with steam supply from Pure Steam Generator
• Quarantine and Release area for incoming raw materials
• Three Quality Control laboratories: general/analytical, microbial, and cell testing
• Dedicated Cell Bank
• Separate Ready Supply and Decontamination areas