- In-dwelling facility to generate NAV Technologies-based mostly AAV gene therapies at 2,000 liters scale
- $65 million invested in new facility, enabling end-to-conclusion regulate of gene therapy producing in Montgomery County, Maryland
ROCKVILLE, Md., June 9, 2022 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) these days is celebrating the opening of its new Production Innovation Center gene treatment production facility.
“Launching functions at our Producing Innovation Heart is an important milestone in the evolution of REGENXBIO,” said Kenneth T. Mills, President and Main Govt Officer of REGENXBIO. “We believe our in-dwelling production capabilities will permit us to swiftly transition creation processes across the product lifecycle, and effectively progress new AAV Therapeutics from investigation and early progress to scientific applications to industrial readiness, and into the hands of clients who may perhaps gain from these possible 1-time administration therapies.”
Located in REGENXBIO’s 132,000 sq. foot headquarters in Rockville, Maryland, the condition-of-the-artwork superior manufacturing follow (GMP) facility will empower the business to strengthen producing of NAV Know-how-primarily based adeno-affiliated virus (AAV) vectors at scales up to 2,000 liters. The facility will put into action REGENXBIO’s NAVXpress™ system suspension mobile lifestyle method, which has shown the means to enhance item purity and produce.
The GMP facility is made to meet up with global scientific and industrial regulatory criteria, and consists of two unbiased bulk drug compound output suites, a ultimate drug solution suite and integrated quality control labs. REGENXBIO is a single of only a handful of gene treatment firms throughout the world with a GMP facility capable of generation at scales up to 2,000 liters.
“In-property production is a critical differentiator for REGENXBIO as a chief in gene remedy,” reported Curran Simpson, Chief Functions and Technologies Officer at REGENXBIO. “High-quality production is essential to all levels of AAV gene remedy enhancement, and we are extremely happy of this chopping-edge facility and the expert crew we have to lead these efforts. Bringing our manufacturing in-house allows us to regulate the procedure from beginning to finish and supplies overall flexibility to assist a huge variety of clinical and industrial requires.”
Through December 31, 2021, REGENXBIO experienced invested more than $100 million into the buildout of its Rockville headquarters, together with additional than $65 million devoted to the Producing Innovation Heart. In preparation to establish conclusion-to-conclusion capabilities in gene therapy from analysis and early progress to commercial completely ready producing, the organization has employed 200 individuals more than the previous two decades.
About REGENXBIO Inc.
REGENXBIO is a main scientific-phase biotechnology enterprise seeking to enhance life through the healing prospective of gene treatment. REGENXBIO’s NAV Engineering Platform, a proprietary adeno-linked virus (AAV) gene supply system, is composed of distinctive rights to far more than 100 novel AAV vectors, together with AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its 3rd-celebration NAV Technological know-how Platform Licensees are implementing the NAV Technological innovation System in the enhancement of a broad pipeline of candidates in many therapeutic areas. REGENXBIO is dedicated to a “5x’25” approach to progress 5 AAV Therapeutics from our inner pipeline and accredited packages into pivotal-stage trials or commercial goods by 2025.
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Source REGENXBIO Inc.