With 30+ years of gene therapy experience, we bring expertise in viral vector manufacturing and testing as well as a global organization to integrate regulatory, safety, and process development to fit your needs.
Leveraging our in-house expertise, we offer a complete range of process development (PD) services to improve yield and quality of your viral vectors.
The breadth of our experience allows us to develop robust production processes to move your gene therapy products quickly through clinical trials and to commercialization.
Our viral and gene therapy manufacturing team has produced over 1,000 batches of virus, meeting rigorous timelines with a complete range of services, a state-of-the-art cGMP facility, and deep regulatory understanding.
With over 30 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 the clinic and scale up to successfully bring your therapy to patients.
The Future of Our Gene Therapy CDMO Through the Lens of History
The Importance of Scalability in Viral Vectors
Understanding the Road to Commercialization - Infographic
How We Handle Quality Inspection Readiness
Overcoming the Biggest Hurdles in Gene Therapy Manufacturing
Updated US FDA Guidance For the Gene Therapy Industry: Key Changes and Areas of Increased Focus
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