The development of gene therapy products is a complex process that requires multidisciplinary expertise and advanced systems to support the production of safe and effective therapies.
Skyline’s fully integrated AAV platform from research to CMC allows us to employ a “quality by design” approach. Our original, in-house designed process and analytical platforms provide robust solutions for the scalable, reproducible, and GMP-compliant production of clinical-grade plasmid and viral vector in a systematic and expeditious manner.
Our state-of-the-art GMP manufacturing consists of multiple platforms that guide and control product safety and efficacy.