Process development

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.

GMP manufacturing

Our state-of-the-art GMP manufacturing consists of multiple platforms that guide and control product safety and efficacy.

Advanced plasmid process platform

High productivity fermentation and purification technology for quality plasmid production at various scales.

Novel viral vector process platform

Suspension technology with transient transfection of HEK293 cells for serotype independent viral vector production with high titer and quality.

Scalable purification platform

Efficient downstream process that achieves high yield and high purity viral products with target F/E ratio.

Comprehensive analytical platform

More than 30 validated analytical methods that thoroughly characterize the product’s physicochemical and biological properties.

Rigorous quality control platform

Full-spectrum testing including assays for identity, quantity, purity, impurities, and biological activity to guarantee product safety and efficacy.