The GMP manufacturing suite is used for clinical-stage manufacturing of AAV-based gene therapy products.
The facility’s 9,300sf footprint will be divided into one seed train suite, two downstream production suites, one fill/finish suite, and support areas for buffer and media preparation. The production module will have the flexibility to host multiple sized bioreactors up to 500L.
The project also has an exterior utility yard that is approximately 3,500sf to support the manufacturing suite.
The facility will house:
- Seed train cell culture including shake flasks and small-scale bioreactors
- Production cell culture including larger scale bioreactors for transfection to produce AAV
- Downstream purification
- Fill/finish and inspection
- Buffer and media preparation
- Cold room storage
Region: AmericasCountry: United StatesOffice: Morrisville, NC
Services: Architecture, Design, ProcessIndustries: Cell and Gene Therapy, Biotechnology & BiomanufacturingFacility Type: Manufacturing
Stephen R. Franey, AIA, NCARB
Thomas J. Piombino
Vice President, Biotechnology Process Architect
Mark E. Rezac, PE
Director, Compliance Services