Manufacturing

Our state-of-the-art REGENXBIO Manufacturing Innovation Center, housed in the same building as our research, process development and clinical teams, allows us to accelerate the development of AAV Therapeutics for patients in need.

This cGMP gene therapy facility expertly designed and built for the manufacturing of NAV Technology-based AAV vectors at scales suitable for commercial production.

The REGENXBIO Manufacturing Innovation Center is built to meet global clinical and commercial regulatory standards, and makes REGENXBIO one of only a few gene therapy companies worldwide with a cGMP facility capable of production at scales up to 2,000 liters.

NAVXpress™

NAVXpress™ is REGENXBIO’s proprietary, high-yielding suspension-based manufacturing process. The NAVXpress platform has demonstrated robust scalability with consistent yield and product purity, both critically important factors for gene therapy manufacturing.bb

We have designed custom raw materials for use in the NAVXpress platform, including plasmids and cell lines, that increase the efficiency and productivity of NAV vectors. We have demonstrated that these cell lines, named NAVXcell®, have the potential to enable high-yielding production processes while allowing for efficient purification.