Manufacturing & Production

REGENXBIO, a clinical-stage biotechnology company, has opened a $65 million Manufacturing Innovation Centre gene therapy manufacturing facility at their campus in Rockville, Maryland, US.

Located in REGENXBIO’s 132,000 square foot headquarters in Rockville, Maryland, the stateof-the-art good manufacturing practice (GMP) will implement the company’s NAVXpress platform suspension cell culture process.

“In-house manufacturing is a key differentiator for REGENXBIO as a leader in gene therapy,” said Curran Simpson, Chief Operations and Technology Officer at REGENXBIO. “Quality manufacturing is crucial to all stages of AAV gene therapy development, and we’re extremely proud of this cutting-edge facility and the experienced team we have to lead these efforts. Bringing our manufacturing in-house allows us to control the process from beginning to end, and provides flexibility to support a wide range of clinical and commercial needs.”

REGENXBIO aims to improve lives through the curative potential of gene therapy. The company’s NAV Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9, and AAVrh10.

In preparation to establish end-to-end capabilities in gene therapy, from research and early development to commercial-ready manufacturing, the company has hired 200 people over the past two years.

“Launching operations at our Manufacturing Innovation Center is an important milestone in the evolution of REGENXBIO,” said Kenneth T. Mills, President and CEO of REGENXBIO. “We believe our in-house manufacturing capabilities will enable us to rapidly transition production processes across the product lifecycle, and efficiently advance new AAV Therapeutics from research and early development to clinical programs to commercial readiness, and into the hands of patients who may benefit from these potential one-time administration therapies.”