Austin AECOM was selected by St. Jude Children’s Research Hospital to design, engineer and construct a small-scale current Good Manufacturing Practices (cGMP) pharmaceutical BSL-3 production facility in Memphis, Tennessee. The project provides the hospital the space it needs to manufacture new cGMP-grade materials in-house for custom pediatric vaccines derived from patients’ own immune systems.
St. Jude will use the facility for multiple processes including peptide synthesis/chemistry and the production of plasmid DNA products, viral vector products, cell therapy products and monoclonal antibodies, and live viral and bacterial vaccines.
The new facility allows St. Jude to create orphan drugs that pharmaceutical and biotechnology companies shy away from because they are too costly to develop.
The new research facility also gives St. Jude the technology and space to develop clinical compounds on contract or through out-licensing. The facility was designed with flexibility, allowing researchers to use space for a variety of products not dedicated to a specific need. The programming and design effort addressed the procedural issues of personnel; material, product and waste flows; HVAC pressurization and zoning; location and access of mechanical systems; and architectural finishes.
Critical systems included purified water (RO), clean steam and water-for-injection (WFI).
The Austin AECOM team also provided commissioning services for the new facility. This required the development of a commissioning master plan that identified all commissioning tasks, pre-functional tests, start-up tests and functional tests for all systems to be commissioned, and the preparation of a final commissioning report.
 St. Jude Children's Research Hospital - Tradeline Article
|
