Aptuit’s High Containment facility in Harrisonville, Mo., provides the rigorous controls necessary to develop and manufacture both new and existing anticancer drugs and other high-potency compounds. This plant is one of only a few facilities worldwide specifically designed to manufacture this class of drugs.
The facility is fully Class 100,000 and was designed using the latest in barrier technology, including isolation chambers and clean-in-place systems. The facility contains three separate suites, each on its own air handling system (HEPA filtration both inbound and exhaust) with separate access and egress points.
The first suite is a glassware laboratory for preclinical development synthesis and kilo-scale batches. The room is equipped with a 100-L Büchi ChemReactor, a walk-in hood for up to 50-L glassware, and a glove box for product isolation and packaging.
The second and third suites are utilized for the production of clinical and commercial supplies. Both rooms contain a custom isolation chamber that incorporates filtration, drying and packaging. The reactors feed directly into these units with waste pumped to storage tanks that are then shipped for incineration. No direct handling of materials by personnel is required.