cGMP Manufacturing Facility
Project Stats
Houston, TX
Completion Date: March 2024 (Scheduled)
Square Feet: 23,000
The 23,000 SF facility will focus on gene therapy CDMO process development and have Good Manufacturing Practice (GMP) manufacturing capabilities. The areas in this facility will include Process and Analytical Development Labs, GMP Manufacturing Clean Rooms and Supporting Areas, QC Labs, Warehouse, Office Space, New Storage Mezzanine above Warehouse and a New Office Mezzanine.
PROJECT DESCRIPTION
The 23,000 SF facility will focus on gene therapy CDMO process development and have Good Manufacturing Practice (GMP) manufacturing capabilities. The areas in this facility will include Process and Analytical Development Labs, GMP Manufacturing Clean Rooms and Supporting Areas, QC Labs, Warehouse, Office Space, New Storage Mezzanine above Warehouse and a New Office Mezzanine.
CLEANROOM DETAILS
CleanSpace is providing a full turnkey package for the Grade A, Grade B, and Grade C space.
The Clinical GMP Process Suite will be developed to realize the following:
- Concurrent processing of multiple gene therapies
- Meet compliance objectives for FDA, EMA, Japan and MHRA
- Provide flexibility in manufacturing
- Provide overall full in-house manufacturing capability, including process and analytical development labs, logistics and quality control labs
- Accommodate potential future expansion into adjacent space