REGENXBIO Opens State-of-the-Art Gene Therapy Manufacturing Facility

“Launching operations at our Manufacturing Innovation Center is an important milestone in the evolution of REGENXBIO,” said Kenneth T. Mills, President and Chief Executive Officer 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.”

Located in REGENXBIO’s 132,000 square foot headquarters in Rockville, Maryland, the state-of-the-art good manufacturing practice (GMP) facility will enable the company to boost manufacturing of NAV Technology-based adeno-associated virus (AAV) vectors at scales up to 2,000 liters. The facility will implement REGENXBIO’s NAVXpress™ platform suspension cell culture process, which has demonstrated the ability to increase product purity and yield.

The GMP facility is designed to meet global clinical and commercial regulatory standards, and includes two independent bulk drug substance production suites, a final drug product suite and integrated quality control labs. REGENXBIO is one of only a few gene therapy companies worldwide with a GMP facility capable of production at scales up to 2,000 liters.

“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.”

Through December 31, 2021, REGENXBIO had invested more than $100 million into the buildout of its Rockville headquarters, including more than $65 million dedicated to the Manufacturing Innovation Center. 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.

REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO’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. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas. REGENXBIO is committed to a “5x’25” strategy to progress five AAV Therapeutics from our internal pipeline and licensed programs into pivotal-stage trials or commercial products by 2025.