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A new gene and cell therapy production facility in Maryland
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A new gene and cell therapy production facility in Maryland

A new gene and cell therapy production facility in Maryland

Precigen’s new manufacturing facility has officially opened its doors in Germantown, Maryland. The wholly-owned subsidiary of Intrexon 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, which supports more than 95 employees.  The facility includes ISO 7 cleanroom suites that will be utilized to manufacture gene therapy vectors, such as adenoviral vectors, 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.  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 Precigen’s 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.


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