API Manufacturing, Accelerated
With cGMP capability and an innovative approach, Cascade Chemistry delivers your API to your clinical trials faster without sacrificing quality. Our expertise begins with process R&D to solve your most complex chemical problems, and our team of scientists stays with you from synthesis through to cGMP clinical manufacturing. Partner with us for right-the-first-time manufacturing.
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.
Our capabilities include:
- 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
Why Cascade Chemistry API Manufacturing
Deep Scientific Expertise – We’ve been solving complex chemistry for over 40 years, and our chemists are experts. More than 75% hold PhDs and have worked an average of 16 years at the bench.
Speed to Clinic –We are agile project managers and involved problem solvers. Our small-business organizational structure dispenses with the cumbersome administrative overhead you often find with a larger CDMO partner.
True Partnership – When you work with Cascade Chemistry, you’ll develop direct relationships with our senior management and the core scientific team, no matter the size of your project. Our support team includes a fully integrated quality and analytical team with a reporting and communication framework that is customized for your needs.
Efficiency from Research to Lab – Our chemists are engaged with your project from Day One, every step of the way from synthesis through to API manufacturing for clinical Phase 1 and 2. With Cascade Chemistry, the transfer from the lab to clinic is seamless.
Built-in Quality – We build quality into our approach from the start, whether we are running your cGMP project or working on your process R&D challenges. Our dedicated quality team and quality-first approach reduce risk and costs later on. In addition in the current environment due to COVID-19, we are offering customers virtual audits to provide peace of mind for both employee safety and project success.
Results for Our Clients
Our clients have received over 30 patents and many – two-thirds – stay with us for more than one project. Here’s just one example why:
Small Southwestern Pharmaceutical Company
Overview: An older API that had not been manufactured in 20+ years returned to the clinic with a new process.
Outcome: Cascade proposed a new synthetic route; quickly proved the material had the same impurity profile with higher overall purity, allowing the client to save money and time with better quality; scaled up the synthesis; and produced clinical material.
- 4 months to develop new route, proof of concept, GLP tox, and GMP manufacturing
- Retrosynthetic analysis experience allowed us to find a simpler, less expensive route
- Understanding of regulatory hurdles for new routes ensured development was fast and on track
Ready to get started on your API?
Call us at 541-484-2387 to discuss your requirements and timeline and find out more about our services and team or contact us to get started today.