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For Curran Simpson, Chief Operations and Technology Officer at REGENXBIO, Maryland has the “ideal mix” of talent for process development and manufacturing. Because if that, it was a no-brainer for the company to opening of its new Manufacturing Innovation Center gene therapy manufacturing facility in Rockville.
The new 132,000 square-foot-facility was designed to boost manufacturing of the company’s NAV Technology-based adeno-associated virus (AAV) vectors at scales up to 2,000 liters. REGENXBIO’s AAV vector platform has been licensed to other companies and was used in the development of Novartis’ Zolgensma, a gene therapy for spinal muscular atrophy. With its new site that 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.
Simpson said the construction of the in-house facility is critical for the company’s role as a leader in gene therapy. He explained that quality manufacturing is crucial for all stages of AAV gene therapy, particularly as the company moves closer to winning regulatory approval for its own treatments. Curran noted that many of the clinical holds that have slowed the development of gene therapies across the industry have been due to CMC-related issues.
“As we moved into late-stage development, it became important for the company to have secure capacity under our control to have internal control over the programs. Because that’s so critical, having that in our direct control will be a huge advantage for REGENXBIO,” he said. “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 is developing gene therapies for a number of rare diseases, including Duchenne Muscular Dystrophy and wet age-related macular degeneration. Both studies are in mid- and late-stage development. Curran said the new manufacturing facility in Rockville should be significant enough to support commercialization efforts should either gene therapy be approved for commercial use.
As REGENXBIO continues to scale, Curran said the location in Maryland provides it with a significant advantage when it comes to recruiting talent. He touted the availability of potential employees that are coming out of academic programs from Montgomery College, the University of Maryland and Johns Hopkins. Curran also noted that many of the federal agencies in the area, such as the U.S. Food and Drug Administration and the National Institutes of Health, also have highly skilled scientists who are potential employees. Curran said that so far, REGENXBIO has not only been successful in its recruiting needs but has also been able to retain talent once they join the company.
“It’s one thing to recruit qualified staff but it’s difficult to retain them. We’ve had success keeping them,” he said. “The manufacturing is only as good as the people working here and we have some great people.”
The new manufacturing center allowed the company to add about 75 new employees who are directly or indirectly associated with manufacturing. Curran said REGENXBIO has plans to add additional employees over the next year, which is in-line with an internal recruiting plan the company established two years ago.
Not only has the new site afforded REGENXBIO the ability to self-govern its manufacturing needs, Curran said they hope to also use the facility in an ambassadorial manner. With close proximity to the FDA, Curran said he hopes to share their own gene therapy training knowledge with the regulatory agency’s staff. The company also hopes to provide some education in gene therapy manufacturing to the local universities and community colleges in order to “grow the next generation” of talent.
“We’re real proud of the type of work we do,” Curran said.
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