REGENXBIO opens Maryland AAV plant

REGENXBIO has launched operations at its $65 million Manufacturing Innovation Center gene therapy facility in Rockville, Maryland.

In 2019 the firm announced its plans to construct a GMP facility at its 132,000 square-foot headquarters in Maryland to produce adeno-associated viral vectors (AAV’s) for its gene therapy programs using its NAV technology-based platform.

Now, REGENXBIO has opened what is has named the “Manufacturing Innovation Center” in Rockville and says it includes AAV vectors at scales of up to 2,000 L. According to the firm, the facility has been designed to meet regulatory requirements and includes two independent bulk drug substance manufacturing suites, integrated quality control labs, and a final drug product suite.

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Furthermore, REGENXBIO claims that its in-house production capabilities will allow the company to rapidly and efficiently advance AAV therapeutics.

“In-house manufacturing has several benefits for us. The facility is co-located in our headquarters, a unique model that allows our research and manufacturing teams to work closely together to help accelerate the development and delivery of new gene therapies,” Curran Simpson, chief operations and technology officer at REGENXBIO told us.

“This in-house facility also allows us to control the manufacturing process from beginning to end. Our Manufacturing Innovation Center was designed to include two independent bulk drug substance production suites, allowing for flexibility to support a wide range of clinical and commercial needs for our pipeline.  This also allows us to have control over capacity, insulating us from swings in the external CMO market that occur for the emerging field and due to COVID-19 vaccine production.”

The firm said last month that contract development manufacturing organization (CDMO) issues validates inhouse gene therapy investment after a problem at an undisclosed CDMO delayed AAV based gene therapy candidate RGX-202 for a Phase I/II clinical trial by between six and twelve months.

In December 2021, REGENXBIO invested over $100 million into the build-out of its headquarters, and more than $65 million of this total as dedicated to the gene therapy plant. Additionally, the firm has hired 200 people over the past two years to secure end-to-end capabilities in gene therapy from research through to commercial manufacturing.

“There is also a strong biopharma talent pool in the capital region [and] in the face of COVID, we were very thorough in our COVID communications and practices, including providing on-site testing and health screenings,” said Simpson.