We have 40+ years of experience solving complex chemistry and accelerating our clients’ drug substances to clinic. With GMP manufacturing capabilities and an innovative approach, Actylis delivers your API to your clinical trials faster while maintaining high quality standards. .
Our expertise begins with process R&D and analytical development to solve your most complex chemical problems, and our team of scientists stays with you from route scouting through to cGMP manufacturing. Our state-of-the-art facilities in Eugene, OR give us the flexibility to work with a variety of chemistries at early to mid-stage development, and onto commercialization.
Our capabilities include:
- cGMP Manufacturing of innovative APIs, excipients, and late-stage intermediates, including materials for clinical studies and small volume commercial products
- cGMP Commercial Manufacturing for low volume APIs
- IND Enabling/GLP Toxicology Batch Manufacturing, making sure you have a representative batch with a repeatable process
- Regulatory Starting Materials manufacturing, small scale to commercial volumes
- Tech Transfer to your best-fit commercial partner, in a seamless and efficient fashion
We build quality into our approach from the beginning, 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, we offer customers in-person or virtual audits to provide peace of mind for both employee safety and project success.
We offer cost effective and rapid solutions for development and manufacturing of cGMP batches of API at 1-10 kg scale with larger capacity GMP API now available at many of our state-of-the-art facilities, including our newest facility opened in early 2023 in Eugene, OR (US). 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.
It is our philosophy that quality is the key component for successful cGMP manufacturing, hence 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.
Flexibility, collaboration, and expertise: that’s what Actylis brings to API process R&D and clinical manufacturing. We are responsive, knowledgeable, accessible, and customer centric. You will always have access to top management and the chemists working on your projects the entire time you’re with us.
Working with Actylis means that your project will benefit from our deep scientific expertise (75% of our chemists have PhDs), customization options, and direct access to our senior leadership & core scientific team throughout the entire process, no matter the size of your project. 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 us, the transfer from the lab to clinic is seamless.
Our customer intimate and flexible approach helps our clients get from route development to the clinic faster, without sacrificing quality. Our support team includes a fully integrated quality and analytical team with a reporting and communication framework that is customized for your needs.
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We are eager to learn about your project and to have the opportunity to help you. Following your submission, an Actylis team member will respond within 24 hours.