REGENXBIO Inc. opened its new Manufacturing Innovation Center gene therapy manufacturing facility at its 132,000 sq.-ft. headquarters in Rockville, MD.
  
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. 
  
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.
 
“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.”