Viral & Gene Therapy Manufacturing CDMO Services
You’ve developed your viral vector gene therapy and now it’s time to embark on the voyage to manufacturing. But gene therapy production is uncharted territory, and you need someone to help navigate through the process. We can help.
With over 25 years of viral vector manufacturing experience, we have charted multiple programs, clinical to commercial. Our experts will guide you through upstream and downstream development, while keeping you from running aground on unexpected regulatory hurdles. With the launch of our large scale CDMO facility, we’ll take you through clinic and scale-up, to successfully bring your therapy to patients. Embark with us on the voyage to commercialization.
Our cGMP state-of-the-art facilities accommodate separate facility areas for scale-up, process validation, phase III trials and commercial launch. Additionally, our large-scale facility supports viral vector manufacturing up to 1,000 L using single-use bioreactors. With our successful history of technology transfers and extensive experience in Process Performance Qualification (PPQ), we continue to partner with leading innovations in gene therapy to meet rigorous commercialization timelines. Our track record includes successful regulatory inspections by the FDA, EMA, PMDA, and TGA.