Hangzhou, Zhejiang, September 28, 2021 – Skyline has recently successfully completed a series of productions at various scales including 200 liters viral vectors in a single batch at its new GMP manufacturing plant. The successful process was part of the company’s multi-production line capacity that enables the parallel production of viral vectors up to thousands of liters per year and planning for the addition of new production lines for larger single batch capacity is underway. The successful productions, with consistent high quality and high yield cross-scale, -batch and -site, were achieved based on Skyline’s proprietary process technologies, which support the scalable and reproducible production of different AAV serotypes.
Skyline’s built-to-suit 70,000-square-foot GMP manufacturing facility, located in Hangzhou, Zhejiang Province, became fully operational in July 2021. It’s part of the company’s inception strategy to establish a fully integrated, proprietary AAV gene therapy platform from discovery to CMC to support its vision of developing and delivering high-quality innovative gene therapy products to patients in need.
To deliver on the strategy, Skyline has built robust process technology platforms and CMC capabilities that support its pipeline lifecycle from in-vitro research and in-vivo study to clinical development. Skyline’s state-of-the-art GMP manufacturing consists of multiple platforms for process and analytics that guide and control product quality, including an advanced plasmid process, a proprietary HEK293 cell lines, an advanced serotype independent viral vector process, and an efficient scalable downstream purification process. As an integral part of the holistic GMP-compliant manufacturing system, a comprehensive analytical platform and a rigorous quality control system were established and implemented to further safeguard the safety and quality of the viral vector products.