EwingCole has extensive experience in the programming, planning, design, and engineering of cGMP manufacturing facilities, with specific expertise in Cell & Gene Therapy Production and Blood Processing Facilities. In the last four years alone EwingCole has successfully designed laboratories, clinical, and commercial cell therapy facilities for the following Cell & Gene Therapy clients:
- Kite Pharma, Inc.
- Legend Biotech
- Novartis
- Precision Biosciences
- REGENXBIO
- Tessa Therapeutics
Cell & Gene Therapy facilities are highly regulated to allow the manufacture of minimally manipulated, complex biotechnology products. The focus of these facilities is on clinical research studies, technology development, and full-scale production. Product manufacturing suites designed for cGMP and GTP (good tissue practices) need to be adaptable to most biologic and cellular processes for clinical trials. End-to-end workflow solutions need to be carefully planned to allow labs to scale up production in different locations.
EwingCole is a leader in the design of:
- Biomanufacturing Cleanroom Suites
- Cell Culture Rooms
- Incubator Rooms
- Single Use Systems
- Media Prep
- Critical Utilities (High Purity Water, Compressed Air, Carbon Dioxide and Liquid Nitrogen Systems)
- QA/QC Laboratories
- Filling and Packaging
- Warehouse, Including Cold and Frozen Material Storage
- Workplace Programming
