Cell & Viral Vector Manufacturing
Expression Manufacturing is a state-of-the-art 43,000 square foot Cell & Viral Vector Manufacturing Facility in West Chester, Ohio. The facility provides in house manufacturing capabilities for Expression Therapeutics product portfolio (γδ T cells, genetically engineered blood stem cells, and viral vectors).
Expression Manufacturing also provides CDMO services to strategic partners and clients. The facility contains both research laboratories for analytical and process development as well as separate areas for early phase and commercial scale manufacturing of both GMP Cell and Viral Vector products. Clinical grade products are manufactured compliant with FDA cGMP regulations by a highly trained and experienced staff using QA issued Batch Records.
Manufacture occurs inside modular ISO Class 7 cleanrooms (from G-CON Bio) with all open manipulations occurring inside ISO Class 5 BSCs. Differential pressure gradients are established between adjacent areas of different ISO class by independent AHUs and magnetically interlocking doors.
All raw materials are single use, sterile, disposable, and properly released. Production equipment is validated and monitored. Personnel training, Quality Assurance, and Controlled document management is managed through Qualio, a part 11 compliant, and validated electronic Quality Management System.
Manufacturing Services Provided:
- Research and Feasibility viral vector production (shake flasks, T225, and 5-stack )
- Pilot and Engineering runs (Full scale, 50%, 10% or custom) for all vectors
- Clinical / GMP grade Lentiviral vector (LV) manufacture (60L or 120L upstream) purified and concentrated
- Clinical / GMP Retroviral vector (RV) manufacture from either transient transfection or producer line (up to 30L scale)
- Clinical / GMP grade AAV (~50 Hyper stacks per sublot)
To learn more or receive a quote, please contact:
William Swaney | President, Manufacturing | [email protected]