Eugene Polk - Cascade
With two cGMP suites and capabilities up to 100L reactors, we can produce batches of up to 10kg and, using multi-batching early steps, up to 40kg. Our 14,000 foot facility in Eugene, Oregon and dedicated team of scientists are primed to make your next project a success.
- Regulatory Starting Materials manufacturing, scaling to over a quarter metric ton per year
- IND Enabling/GLP Toxicology Batch Manufacturing, making sure you have a representative batch with a repeatable process
- cGMP Clinical Manufacturing, including materials for Phase 1 & 2 studies
- Tech Transfer to seamlessly and efficiently hand over to your best-fit commercial partner
We offer cost effective and rapid solutions for development and manufacturing of cGMP batches of API at 1-10 kg scale with larger capacity CGMP API to be available at our new site in 2022. Our PhD Chemists are capable of crafting process solutions tailored to your specific needs.
Quality Assurance and Quality Control
We adhere to the strict quality standards specified in Title 21 part 210 of the code of federal regulations.
It is our philosophy that quality is the key component for successful cGMP manufacturing, 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 customer craft a process solution which meets your needs and quality requirements