Good Manufacturing Practice (GMP)
Beyond process development and scale-up, Cascade Chemistry specializes in cGMP manufacturing. We offer cost effective and rapid solutions for development and manufacturing of cGMP batches of API at 1-5 kg scale with larger capacity and commercial GMP API to be avaialble at our new site in 2020. Our PhD chemists are capable of crafting process solutions tailored to your specific needs while adhering to the strict quality standards specified in Title 21 part 210 of the code of federal regulations. Through our partnership in SeránCascade, we are also able to provide Spray Dried Dispersions, and formulated drug product. In 2017, the partnership commissioned a state of the art GMP facility with three clean rooms in nearby Bend, Oregon.
It is our philosophy that quality is the key component for successful cGMP manufacturing and so our quality system exceeds what is required by the FDA for the manufacture of pharmaceutical products. We understand that quality is not simply a component which is applied to a product after processing, but rather quality is a guiding virtue by which compliance is built into a product through due diligence at each step of a process. Allow our problem solvers to custom craft a process solution which meets your needs and quality requirements.
If you’d like to receive an estimate or discuss a project, call us at 541-484-2387 or contact us by clicking here.