Industryweek 34810 Precigen 1

New Gene Therapy Manufacturing Plant Opens In Maryland

April 30, 2019
The good manufacturing practices 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.

Precigen, Inc., a clinical stage biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, announced on April 26 the official opening of its new manufacturing facility.

The company, a wholly-owned subsidiary of Intrexon Corp., commenced the build-out of the nearly 5,000 square foot manufacturing facility in 2018 to support gene therapy manufacturing. The new facility adds to Precigen's existing footprint in Germantown, Md., which supports more than 95 employees.

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.

"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 Helen Sabzevari, President of Precigen,Dr.  "This facility puts Precigen in control of our gene therapy manufacturing needs."

Precigen has a Cooperative Research and Development Agreement with the National Center Institute to evaluate Precigen's proprietary adenoviral vaccines in preclinical and clinical studies for the treatment of cancer.

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 clinical trials and will occur at clinical centers through its non-viral gene transfer rapid manufacturing process. Rapid manufacturing of UltraCAR 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.

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