NATIONAL CENTER FOR THERAPEUTICS
Headquartered in College Station, Texas, Kalon operates the National Center for Therapeutics Manufacturing (NCTM), a first-in-class, “flexible by design” center for biotherapeutics research, development, workforce training, GMP manufacturing, and purification up to 2,000 L scale for clinical trial up to Phase III “run in.”
The NCTM is the cornerstone for a globally competitive biomedical campus emphasizing intermediate and advanced development of biological pharmaceuticals.
A mobile clean room (MCR) is a portable, self-contained environment that allows for drug development in multiple locations. The key to the design of these MCRs is that they are self-contained with inherent air handling and other critical equipment and controls components.
Each MCR is used for a single, biologically distinct technology (bacteria, mammalian cells, plants, etc.), thereby eliminating any cross-contamination issues with regulatory agencies.
When pods are not in use, they are moved to cleaning/refurbishing areas and ready pods are “plugged in” for manufacturing.