Manufacturing
World Class Facility
Purpose-built facility staffed by highly specialized scientists, engineers and technicians.
Fully Integrated
150,000 sq. ft., including laboratory and advanced manufacturing space for cellular medicine and biomaterial products.
Scalable Production
Clinical Scale – (9) Grade C/ISO 7 GMP suites and (6) Grade D/ISO 8 GMP labs
Highly Scalable Biosourcing and In-House GMP Manufacturing
Our Celularity IMPACT manufacturing process is a seamless, fully integrated process designed to optimize speed and scalability, from the sourcing of placentas from full-term healthy informed consent donors through the use of proprietary processing methods, cell selection, product-specific CMC, advanced cell manufacturing and cryopreservation. The result is a suite of allogeneic inventory-ready, on-demand placental-derived cell therapy products.
Manufacturing allogeneic therapeutic candidates involves a series of precise steps. Applying proprietary manufacturing know-how, expertise and capacity utilizing our purpose-built U.S.-based cGMP compliant facility, we believe our fully integrated manufacturing operations and infrastructure will allow us to improve the manufacturing process, eliminate reliance on contract manufacturing organizations, or CMOs, and more rapidly advance therapeutic candidates.
At the hospital
- Donor screening, enrollment, informed consent, qualification and selection
- Biomaterial collection and testing
At our manufacturing facility
- Proprietary process for cell harvesting and selection
- Master cell bank establishment
- Advanced cell and biomaterial manufacturing