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- 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.
Ahead-Searching Statements
This push release includes “forward-wanting statements,” in just the which means of Portion 27A of the Securities Act of 1933, as amended, and Segment 21E of the Securities Exchange Act of 1934, as amended. These statements convey a belief, expectation or intention and are usually accompanied by text that express projected future activities or results these kinds of as “think,” “may well,” “will,” “estimate,” “continue on,” “foresee,” “think,” “style and design,” “intend,” “anticipate,” “could,” “strategy,” “probable,” “predict,” “look for,” “need to,” “would” or by variations of this kind of text or by very similar expressions. The ahead-on the lookout statements consist of statements relating to, amid other points, REGENXBIO’s manufacturing capabilities. REGENXBIO has dependent these ahead-wanting statements on its current expectations and assumptions and analyses created by REGENXBIO in mild of its encounter and its perception of historic trends, existing ailments and anticipated foreseeable future developments, as well as other factors REGENXBIO believes are ideal below the situation. On the other hand, regardless of whether precise final results and developments will conform with REGENXBIO’s expectations and predictions is issue to a variety of dangers and uncertainties, which includes the timing of enrollment, commencement and completion and the results of scientific trials carried out by REGENXBIO, its licensees and its associates, the timing of commencement and completion and the results of preclinical experiments performed by REGENXBIO and its enhancement partners, the timely enhancement and start of new merchandise, the capacity to get and keep regulatory acceptance of product or service candidates, the capability to attain and manage intellectual property safety for solution candidates and engineering, developments and troubles in the organization and marketplaces in which REGENXBIO operates, the sizing and expansion of potential markets for item candidates and the capacity to serve these marketplaces, the rate and diploma of acceptance of solution candidates, the impression of the COVID-19 pandemic or comparable public health and fitness crises on REGENXBIO’s business, and other things, numerous of which are outside of the manage of REGENXBIO. Refer to the “Danger Elements” and “Management’s Dialogue and Investigation of Economic Issue and Outcomes of Operations” sections of REGENXBIO’s Annual Report on Kind 10-K for the yr ended December 31, 2021, and equivalent “danger variables” sections of REGENXBIO’s Quarterly Studies on Variety 10-Q and other filings, which have been submitted with the U.S. Securities and Exchange Fee (SEC) and are readily available on the SEC’s website at www.sec.gov. All of the forward-hunting statements designed in this press launch are expressly skilled by the cautionary statements contained or referred to herein. The actual outcomes or developments predicted may not be recognized or, even if substantially realized, they may possibly not have the envisioned repercussions to or consequences on REGENXBIO or its enterprises or functions. Such statements are not guarantees of upcoming efficiency and genuine effects or developments may vary materially from those projected in the ahead-searching statements. Viewers are cautioned not to count also closely on the ahead-wanting statements contained in this press launch. These forward-hunting statements speak only as of the day of this push release. Apart from as necessary by law, REGENXBIO does not undertake any obligation, and specially declines any obligation, to update or revise any ahead-on the lookout statements, regardless of whether as a end result of new data, future situations or or else., Inc. All other logos referenced herein are registered logos of REGENXBIO.
Contacts:
Dana Cormack
Company Communications
Traders:
Chris Brinzey
ICR Westwicke
339-970-2843
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Source REGENXBIO Inc.
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