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REGENXBIO has opened a new in-house facility at its headquarters in Rockville, Md., that will be used to manufacture AAV gene therapies at commercial scale.
REGENXBIO, a clinical-statge biotechnology company, announced the opening of its new manufacturing innovation center for gene therapy manufacturing in Rockville, Md. on June 9, 2022. The company has invested $65 million to enable end-to-end control of gene therapy manufacturing at the center.
The good manufacturing practices (GMP) facility will enable the company to boost manufacturing of adeno-associated virus (AAV) vectors using its NAV Technology. Production can be scaled up to 2000 L. The facility will implement the company’s NAVXpress platform, a suspension cell culture process that has demonstrated increased product purity and yield.
The GMP facility has been designed to meet global clinical and commercial regulatory standards. It includes two independent bulk drug substance production suites, a final drug product suite, and integrated quality control labs.
“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, in a company press release. “We believe our in-house manufacturing capabilities will enable us to rapidly transition production processes across the product lifecycle and efficiently advance new AAV [t]herapeutics 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.”
“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,” said Curran Simpson, chief operations and technology officer at REGENXBIO, in the press relese.