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GMP facility allows for an increase in AAV vector production
REGENXBIO Inc. has opened of its new Manufacturing Innovation Center, which is a gene therapy manufacturing facility.
Located in the biotech company’s 132,000 square-foot headquarters in Rockville, MD, the state-of-the-art good manufacturing practice (GMP) center 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, as executive note, has demonstrated the ability to boost 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.
”… 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,” says Curran Simpson, REGENXBIO’s chief operations and technology officer. “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.“