-Nearly 5,000 square foot facility will manufacture early stage clinical trial material for gene therapy trials
GERMANTOWN, Md., April 25, 2019 /PRNewswire/ -- Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (XON) and a clinical stage biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced the official opening of its new manufacturing facility. Precigen commenced the build-out of the nearly 5,000 square foot manufacturing facility in 2018 to support gene therapy manufacturing. The good manufacturing practices (GMP) facility was designed with agility and control in mind, focusing on rapid manufacturing and the ability to scale production appropriately to meet early stage clinical trial needs. The new facility adds to Precigen's existing footprint in Germantown, Maryland, which supports more than 95 employees. To mark the official opening, the company held a ribbon cutting ceremony attended by elected officials and local community members with remarks from Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon, Helen Sabzevari, PhD, President of Precigen, United States Congressman David Trone representing Maryland's 6th Congressional District and Jeffrey Schlom, PhD, Chief of the Laboratory of Tumor Immunology and Biology at the Center for Cancer Research, National Cancer Institute. Dr. Schlom is the principal investigator of a Cooperative Research and Development Agreement (CRADA) between the National Cancer Institute and Precigen. Under this CRADA, the National Cancer Institute and Precigen are collaborating to evaluate Precigen's proprietary adenoviral vaccines in preclinical and clinical studies for the treatment of cancer.
"We need to think long-term by supporting scientific research that will improve the lives of patients and create a better future for our children," said Congressman David Trone (MD-06). "Precigen's new manufacturing facility in Germantown will both create jobs and support the fantastic research that Precigen is conducting to help save lives."
"Precigen needs to be agile and cost-conscious in our early stage clinical manufacturing. In today's drug development environment, it's important to reduce a myriad of risks that can impact manufacturing such as technology transfer risks when outsourcing to contract manufacturing organizations as well as process and timing risks," said Dr. Sabzevari. "This facility puts Precigen in control of our gene therapy manufacturing needs."
The facility includes ISO 7 cleanroom suites that will be utilized to manufacture gene therapy vectors, such as adenoviral vectors, including AdenoVerse™ vaccines and AdenoVerse™ cytokine therapies, as well as cell banks for early stage gene therapy trials. Due to the flexible design, other types of cell-based biopharmaceutical products can also be manufactured in the facility. Additionally, the facility includes a GMP quality control laboratory that supports lot release and stability testing.
Precigen's multimodal manufacturing strategy increases patient access through shortening manufacturing times using both centralized and decentralized manufacturing processes. This new state-of-the-art facility supports the company's centralized manufacturing capacity needs for gene therapy vector production, initially centered around viral vectors, used in early stage clinical trials.
Precigen's decentralized manufacturing will be utilized for UltraCAR-T™ clinical trials and will occur at clinical centers through its non-viral gene transfer rapid manufacturing process. Rapid manufacturing of UltraCAR-T™ cells using our proprietary non-viral gene transfer process eliminates the need for ex vivo propagation, thus dramatically reducing wait times for patients from weeks to less than two days.
Precigen : Advancing Medicine with Precision™
Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cellular therapies using precision technology to target the most urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. Precigen also follows the science opportunistically in pursuit of promising programs in emerging therapeutics. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization. Precigen was founded as a wholly-owned subsidiary of Intrexon Corporation (XON) and leverages Intrexon's proprietary technology platforms to advance human health. For more information about Precigen, visit www.precigen.com or follow us on Twitter @Precigen and LinkedIn.
Precigen Media Contact:
Donelle M. Gregory
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