04.26.19
Precigen, Inc., a wholly-owned subsidiary of Intrexon Corp. and a clinical stage biopharmaceutical company specializing in the development of gene and cellular therapies has opened its new manufacturing facility in Germantown, MD. The nearly 5,000 square foot GMP manufacturing facility was designed for 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 has more than 95 employees.
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 lab that supports lot release and stability testing.
Precigen's manufacturing strategy increases patient access through shortening manufacturing times using both centralized and decentralized manufacturing processes. This new 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 the company’s non-viral gene transfer process eliminates the need for ex vivo propagation, reducing wait times for patients from weeks to less than two days.
"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, president of Precigen. "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 lab that supports lot release and stability testing.
Precigen's manufacturing strategy increases patient access through shortening manufacturing times using both centralized and decentralized manufacturing processes. This new 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 the company’s non-viral gene transfer process eliminates the need for ex vivo propagation, reducing wait times for patients from weeks to less than two days.
"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, president of Precigen. "This facility puts Precigen in control of our gene therapy manufacturing needs."
