Why Analytical Services Matter
When analytical services are working, you barely notice it. When they’re not, it can mean delays or worse, a failed project. The key to success is an experienced analytical team that understands where you need to go with the science and the regulatory process that will prepare you for whatever lies ahead.
Complete Analytical Services Capabilities
At Cascade Chemistry, our analytical team is a key component to project success. Our expert analytical team:
- Consists of 75% PhD chemists who go beyond to solve your analytical problems.
- Engages early and often and is informed by regulatory requirements and the GMP end goal
- Develops and validates methods concurrent with synthesis development, continually challenging methods while new routes are developed
- Interrogates its own methods, asking if their methods are not just telling what they want to know, but also what they need to know
- Continuously looks for clues through impurity tracing and analyzing reaction results data to help the synthetic team fix things, before they turn into problems
- Guides clients through the FDA process
- Works closely with our quality control team providing them with test methods for use in API manufacturing
Our analytical team works in a 14,000 foot facility based in Eugene, Oregon. There we have two cGMP suites and capabilities of up to 100L reactors that produce up to 10kg batches and, using a multi-batching approach, up to 40kg.
Specific services include:
- Method Development and Validation – includes development of purity/impurity methods and wt/wt assays with phase appropriate validation
- Quality Control Testing – working with the client to set specifications appropriate for the molecule and use testing to ensure that quality has been built into the system
- Reference Standard Qualification – synthesizing, purifying, and qualifying wt/wt reference standards, chiral standards, and impurity standards
- Stability Studies – includes forced degradation and stability indicating method development
Why Cascade Chemistry Analytical Services
Deep Scientific Expertise – We’ve been solving complex chemistry for over 40 years, and our chemists are experts – 75% of our analytical chemists hold PhDs and our scientists have an average of 14 years on the bench.
Broad Experience across Compound Classes – Over the years we’ve worked in many different classes of compounds from prostaglandins to heterocycles. We aren’t afraid of lengthy syntheses with carbon-carbon bond formations, asymmetric syntheses, and development of protecting group strategies.
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. Additionally, in the current COVID-19 environment, we are offering customers virtual audits to provide peace of mind for both employee safety and project success.
True Partnership – You will have access to 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.
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:
A California Bioscience Company
Overview: Our client had a product candidate that needed new route development and tech transfer to a large-scale facility for commercial manufacturing. The original analytical methods were developed for a previous process and were not sensitive enough to analyze the new route intermediates or impurities.
Outcome: Cascade’s Analytical group immediately started working with the synthetic team to develop methods for in-process control but quickly realized a mixture of different methods were going to be needed for different impurities. A subset of impurities had very similar structures to the API and appeared to be shoulders on the main peak. The analytical team had seen a similar problem in the past solved with chiral phases so were able to quickly screen a number of phases and find one that gave good separation. This allowed the synthetic chemists to discover there was a problem with the route and design a set of experiments to reduce the impurities and have the material meet the needed impurity profile.
- Close collaboration between the analytical team, the synthetic team, and the client’s technical team allowed identification of impurities.
- Experience enabled the team to find co-eluting peaks and develop methods to separate them.
- Because of the tight timelines on the project, management got extra personnel and extra hours to move development faster.
When Can We Start?
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.